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Notice

Annual Comprehensive List of Guidance Documents at the Food and Drug Administration

Document Details

Information about this document as published in the Federal Register.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is publishing its annual comprehensive list of all guidance documents currently in use at the agency. This list is being published under 21 CFR 10.115(n)(2) of FDA's regulation on Good Guidance Practices (GGPs). This list is intended to inform the public of the existence and availability of all of our current guidance documents. It also provides information on guidance documents that have been added or withdrawn in the past year.

DATES:

We welcome general comments on this list and on agency guidance documents at any time.

ADDRESSES:

Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov.dockets/​ecomments. We have provided information in the tables below on where to obtain a single copy of any of the guidance documents listed.

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FOR FURTHER INFORMATION CONTACT:

Carol A. Kimbrough, Office of Policy, Planning, and Legislation (HF-26), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3480.

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SUPPLEMENTARY INFORMATION:

I. Background

We published our final rule on GGPs in the Federal Register of September 19, 2000 (65 FR 56468), and they became effective October 19, 2000. GGPs are intended to ensure involvement of the public in the development of guidance documents, and to enhance understanding of the availability, nature, and legal effect of such guidance. We committed in the GGPs to publishing annually a comprehensive list of guidance documents. This list updates a comprehensive list published July 21, 2000 (65 FR 45428).

The following comprehensive list identifies all final guidances that have been issued and are in use, and all draft guidances that have been distributed for comment and not for implementation. Any guidances that have been withdrawn this year are also listed. We have organized the documents by the issuing Center or Office within FDA, and we have identified the pertinent intended users or regulatory activities. The dates in the list refer to the date we issued the guidances or, where applicable, the last date we revised a document. Because each issuing Center or Office maintains its own database, there are slight variations in the way in which they provide information on the tables below.

The following most frequently used Internet sites for agency guidances are provided for future reference:

CBER: http://www.fda.gov/​cber/​guidelines.htm

CDER: http://www.fda.gov/​cder/​guidance/​index.htm

CDRH: http://www.fda.gov/​cdrh/​guidance.html

CFSAN: http://www.cfsan.fda.gov/​dms/guidance.html

CVM: http://www.fda.gov/​cvm/​guidance/​published.htm#documents

ORA: http://www.fda.gov/​ora/​compliance;​ref

II. Guidance Documents Issued by the Center for Biologics Evaluation and Research (CBER)

Name of DocumentDate of IssuanceIntended User or ­Regulatory ActivityHow to Obtain a Hard Copy of the ­Document
Interpretative Guidelines of the Source Plasma (Human) StandardsOctober 2, 1973FDA Regulated IndustryOffice of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 1-800-835-4709 or 301-827-1800, FAX Information System: 1-888-CBER-FAX (within U.S.) or 301-827-3844 (outside U.S. and local to Rockville, MD). Internet access: http://www.fda.gov/​cber
Guidelines for Reviewing Amendments to Include Plasmapheresis of HemophiliacsJuly 20, 1976DoDo
Package Insert: Immune Serum Globulin (Human)March 30, 1978DoDo
Guidelines for Interpretation of Potency Test Results for All Forms of Adsorbed Diphtheria and Tetanus ToxoidsApril 12, 1979DoDo
Guidelines for Immunization of Source Plasma (Human) Donors With Blood SubstancesJune 1, 1980DoDo
Collection of Human Leukocytes for Further Manufacturing (Source Leukocytes)January 28, 1981DoDo
Platelet Testing Guidelines—Approval of New Procedures and EquipmentJuly 1, 1981DoDo
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Revised Guideline for Adding Heparin to Empty Containers for Collection of Heparinized Source Plasma (Human)August 1, 1981DoDo
Requirements for Infrequent Plasmapheresis DonorsAugust 27, 1982DoDo
Recommendations to Decrease the Risk of Transmitting AIDS From Plasma DonorsMarch 24, 1983DoDo
PTC in the Manufacture of In Vitro Monoclonal Antibody Products Subject to LicensureJune 20, 1983DoDo
Draft PTC in the Production and Testing of Interferon Intended for Investigational Use in Humans (Interferon Test Procedures)July 28, 1983DoDo
Interstate Shipment of Interferon for Investigational Use in Laboratory Research Animals or Tests in VitroNovember 21, 1983DoDo
Deferral of Blood Donors Who Have Received the Drug Accutane (Isotretinoin/Roche); 13-cis-retinoic acid)February 28, 1984DoDo
Equivalent Methods for Compatibility TestingDecember 14, 1984DoDo
Plasma Derived From Therapeutic Plasma ExchangeDecember 14, 1984DoDo
Draft PTC in the Production and Testing of New Drugs and Biologicals Produced by Recombinant DNA TechnologyApril 10, 1985DoDo
Guidelines for Meningococcal Polysaccharide VaccinesJuly 17, 1985DoDo
Guideline for the Uniform Labeling of Blood and Blood ComponentsAugust 1, 1985DoDo
Recommended Methods for Short Ragweed Pollen ExtractsNovember 1, 1985DoDo
Reduction of the Maximum Platelet Storage Period to 5 Days in an Approved ContainerJune 2, 1986DoDo
To In Vitro Diagnostic Reagent Manufacturers: Guidance on the Labeling of Human Blood Derived in Vitro Diagnostic Devices in Regard to Labeling for HTLV-III/LAV Antibody TestingDecember 6, 1986DoDo
Guideline for Submitting Documentation for the Stability of Human Drugs and BiologicsFebruary 1, 1987DoDo
Guideline for Submitting Documentation for Packaging for Human Drugs and BiologicsFebruary 1, 1987DoDo
Guideline on General Principles of Process ValidationMay 1, 1987DoDo
Guideline on Sterile Drug Products Produced by Aseptic ProcessingJune 1, 1987DoDo
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Deferral of Donors Who Have Received Human Pituitary-Derived Growth HormoneNovember 25, 1987DoDo
Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical DevicesDecember 1, 1987DoDo
Recommendations for the Management of Donors and Units That Are Initially Reactive for Hepatitis B Surface Antigen (HBsAg)December 2, 1987DoDo
Extension of Dating Period for Storage of Red Blood Cells, FrozenDecember 4, 1987DoDo
To Licensed In Vitro Diagnostic Manufacturers: Handling of Human Blood Source MaterialsDecember 23, 1987DoDo
Recommendations for Implementation of Computerization in Blood EstablishmentsApril 6, 1988DoDo
Control of Unsuitable Blood and Blood ComponentsApril 6, 1988DoDo
Discontinuance of Prelicensing Inspection for Immunization Using Licensed Tetanus Toxoid and Hepatitis B and Rabies VaccinesJuly 7, 1988DoDo
Physician SubstitutesAugust 15, 1988DoDo
To Licensed Manufacturers of Blood Grouping Reagents: Criteria for Exemption of Lot ReleaseAugust 26, 1988DoDo
Revised Guideline for the Collection of Platelets, PheresisOctober 7, 1988DoDo
To Manufacturers of HTLV-I Antibody Test Kits: Antibody to Human T-Cell Lymphotropic Virus, Type I (HTLV-I) Release Panel IOctober 18, 1988DoDo
Draft Guideline for the Design of Clinical Trials for Evaluation of Safety and Efficacy of Allergenic Products for Therapeutic UsesNovember 1, 1988DoDo
HTLV-I Antibody TestingNovember 29, 1988DoDo
Use of Recombigen HIV-1 LA TestFebruary 1, 1989DoDo
Guidelines for Release of Pneumococcal Vaccine, PolyvalentFebruary 1, 1989DoDo
Guidance for Autologous Blood and Blood ComponentsMarch 15, 1989DoDo
HTLV-I Antibody TestingJuly 6, 1989DoDo
Use of Recombigen HIV-1 Latex Agglutination (LA) TestAugust 1, 1989DoDo
Draft PTC in the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Antibodies to Human Immunodeficiency Virus Type 1 (1989)August 8, 1989DoDo
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PTC in the Collection, Processing and Testing of Ex Vivo Activated Mononuclear Leukocytes for Administration to HumansAugust 22, 1989DoDo
Information Relevant to the Manufacture of Acellular Pertussis VaccineAugust 23, 1989DoDo
FDA Regulated Industries for Drug Master FilesSeptember 1, 1989DoDo
Requirements for Computerization of Blood EstablishmentsSeptember 8, 1989DoDo
Abbott Laboratories' HIVAG-1 Test for HIV-1 Antigen(s) Not Recommended for Requirements for Computerization of Blood EstablishmentsOctober 4, 1989DoDo
Guideline for Collection of Blood or Blood Products From Donors With PositiveTests for Infectious Disease Markers (“High Risk” Donors)October 26, 1989DoDo
Guideline for Determination of Residual Moisture in Dried Biological ProductsJanuary 1, 1990DoDo
Autologous Blood Collection and Processing ProceduresFebruary 12, 1990DoDo
Cytokine and Growth Factor Pre-Pivotal Trial Information PackageApril 2, 1990DoDo
Use of Genetic Systems HIV-2 EIAJune 21, 1990DoDo
PTC in the Safety Evaluation of Hemoglobin-Based Oxygen CarriersAugust 21, 1990DoDo
Guideline on the Preparation of Investigational New Drug Products (Human and Animal)March 1, 1991DoDo
FDA Request for Information on Blood Storage Patterns and Red Cell Contamination by Yersinia EnterocoliticaMarch 15, 1991DoDo
Revision to October 26, 1989, Guideline for Collection of Blood or Blood Products From Donors With Positive Tests for Infectious Disease Markers (High Risk Donors)March 17, 1991DoDo
Deficiencies Relating to the Manufacture of Blood and Blood ComponentsMarch 20, 1991DoDo
Responsibilities of Blood Establishments Related to Errors and Accidents in the Manufacture of Blood and Blood ComponentsMarch 20, 1991DoDo
To Biologic Product Manufacturers—Controlling Materials of Bovine or Ovine OriginMay 3, 1991DoDo
FDA Recommendations Concerning Testing for Antibody to Hepatitis B Core Antigen (Anti-HBc)September 10, 1991DoDo
Disposition of Blood Products Intended for Autologous Use That Test Repeatedly Reactive for Anti-HCVSeptember 11, 1991DoDo
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Clarification of FDA Recommendations for Donor Deferral and Product Distribution Based on the Results of Syphilis TestingDecember 12, 1991DoDo
Recommended Methods for Blood Grouping Reagents EvaluationMarch 1, 1992DoDo
Recommended Methods for Evaluating Potency, Specificity and Reactivity of Anti-Human GlobulinMarch 1, 1992DoDo
PTC in the Design and Implementation of Field Trials for Blood Grouping Reagents and Anti-Human GlobulinMarch 1, 1992DoDo
PTC in the Manufacture of In Vitro Monoclonal Antibody Products for Further Manufacturing into Blood Grouping Reagent and Anti-Human GlobulinMarch 1, 1992DoDo
Supplement to the PTC in the Production and Testing of New Drugs and Biologicals Produced by Recombinant DNA Technology: Nucleic Acid Characterization and Genetic StabilityApril 6, 1992DoDo
Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood ProductsApril 23, 1992DoDo
Use of Fluorognost HIV-1 Immunofluorescent Assay (IFA)April 23, 1992DoDo
Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV)April 23, 1992DoDo
Exemptions to Permit Persons With a History of Viral Hepatitis Before the Age of Eleven Years to Serve as Donors of Whole Blood and Plasma; Alternative Procedures, 21 CFR 640.120April 23, 1992DoDo
Changes in Equipment for Processing Blood Donor SamplesJuly 21, 1992DoDo
Nomenclature for Monoclonal Blood Grouping ReagentsSeptember 28, 1992DoDo
Volume Limits for Automated Collection of Source PlasmaNovember 4, 1992DoDo
FDA's Policy Statement Concerning Cooperative Manufacturing Arrangements for Licensed BiologicsNovember 25, 1992DoDo
Revision of October 7, 1988, Memo Concerning Red Blood Cell Immunization ProgramsDecember 16, 1992DoDo
Draft PTC in the Characterization of Cell Lines Used to Produce BiologicalsJuly 12, 1993DoDo
CBER Refusal to File (RTF) Guidance for Product and Establishment License ApplicationsJuly 12, 1993DoDo
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Guidance on Alternatives to Lot Release for Licensed Biological ProductsJuly 20, 1993DoDo
Recommendations Regarding License Amendments and Procedures for Gamma Irradiation of Blood ProductsJuly 22, 1993DoDo
Deferral of Blood and Plasma Donors Based on MedicationsJuly 28, 1993DoDo
Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV)August 19, 1993DoDo
Changes in Administrative ProceduresSeptember 9, 1993DoDo
To Sponsors of INDs Using Retroviral VectorsSeptember 20, 1993DoDo
Draft Guideline for the Validation of Blood Establishment Computer SystemsSeptember 28, 1993DoDo
Methods of the Allergenic Products Testing LaboratoryOctober 1, 1993DoDo
Application of Current Statutory Authorities to Human Somatic Cell Therapy Products and Gene Therapy Products; NoticeOctober 14, 1993DoDo
Guideline for Adverse Experience Reporting for Licensed Biological ProductsOctober 15, 1993DoDo
Guidance Regarding Post Donation Information ReportsDecember 10, 1993DoDo
To Manufacturers: Bovine Derived Materials (BSE)December 17, 1993DoDo
Donor Suitability Related to Laboratory Testing for Viral Hepatitis and a History of Viral HepatitisDecember 22, 1993DoDo
Compliance Program Guidance Manual (Drugs and Biologics)1994DoNational Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, 703-605-6050 (NTIS Order No. 94-920699)
Recommendations for the Invalidation of Test Results When Using Licensed Viral Marker Assays to Screen DonorsJanuary 3, 1994DoOffice of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 1-800-835-4709 or 301-827-1800, FAX Information System: 1-888-CBER-FAX (within U.S.) or 301-827-3844 (outside U.S. and local to Rockville, MD). Internet access: http://www.fda.gov/​cber
To Sponsors of INDs for Human Immunoglobulin ProductsMay 23, 1994DoDo
To Manufacturers of Licensed Anti-HIV Test KitsMay 26, 1994DoDo
Recommendations for Deferral of Donors for Malaria RiskJuly 26, 1994DoDo
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ICH Guideline for Industry: Studies in Support of Special PopulationsAugust 1, 1994DoDo
OELPS, Advertising and Promotional Labeling Staff Procedural Guidance Document (Draft)August 1, 1994DoDo
ICH Guideline for Industry: Stability Testing of New Drug Substances and ProductsSeptember 1, 1994DoDo
Guide to Inspections of Blood Banks, Division of Field Investigations, Office of Regional Operations, Office of Regulatory AffairsSeptember 1, 1994FDA PersonnelDo
Letter to Manufacturers of Immune Globulin Intravenous (Human) (IGIV), Aseptic Meningitis SyndromeOctober 3, 1994FDA Regulated IndustryDo
Guidance on Alternatives to Lot Release for Licensed Biological ProductsOctober 27, 1994DoDo
Guidance for Industry: For the Submission of Chemistry, Manufacturing, and Controls Information for Synthetic Peptide SubstancesNovember 1994DoDo
Recommendations to Users of Medical Devices That Test for Infectious Disease Markers by Enzyme Immunoassay (EIA) Test SystemsDecember 20, 1994DoDo
To Manufacturers of Immune Globulin Products: Testing for Hepatitis C Virus RNA ImmunoglobulinDecember 27, 1994DoDo
Timeframe for Licensing Irradiated Blood ProductsFebruary 3, 1995DoDo
Home Specimen Collection Kit Systems Intended for Human Immunodeficiency Virus (HIV-1 and/or HIV-2) Antibody Testing; Revisions to Previous GuidanceFebruary 23, 1995DoDo
ICH Guideline for Industry: Clinical Safety Data Management: Definitions and Standards for Expedited ReportingMarch 1, 1995DoDo
To Manufacturers of Intramuscular Immune Globulin Products: HCV RNA Testing by PCRMarch 3, 1995DoDo
Revision of 8/27/82 FDA Memo: Requirements for Infrequent Plasmapheresis DonorsMarch 10, 1995DoDo
To Manufacturers of Intramuscular Immune Globulin Products: Additional Information Regarding HCV RNA Testing by PCRMarch 13, 1995DoDo
To Health Professionals: Implementation of Testing for HCV RNA by PCR for Immune Globulin Products for Intramuscular AdministrationMarch 14, 1995DoDo
To All Establishments Performing Red Blood Cell Immunizations: Revised Recommendations for Red Blood Cell Immunization Programs for Source PlasmaMarch 14, 1995DoDo
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Recommendations for the Deferral of Current and Recent Inmates of Correctional Institutions as Donors of Whole Blood, Blood Components, Source Leukocytes and Source PlasmaJune 8, 1995DoDo
Guideline for Quality Assurance in Blood EstablishmentsJuly 11, 1995DoDo
FDA Guidance Document Concerning Use of Pilot Manufacturing Facilities for the Development and Manufacture of Biological ProductsJuly 11, 1995DoDo
Disposition of Products Derived From Donors Diagnosed With, or at Known High Risk for, Creutzfeldt-Jakob DiseaseAugust 8, 1995DoDo
Recommendations for Labeling and Use of Units of Whole Blood, Blood Components, Source Plasma, Recovered Plasma or Source Leukocytes Obtained From Donors With Elevated Levels of Alanine Aminotransferase (ALT)August 8, 1995DoDo
Precautionary Measures to Further Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease by Blood and Blood ProductsAugust 8, 1995DoDo
Recommendations for Donor Screening With a Licensed Test for HIV-1 AntigenAugust 8, 1995DoDo
PTC in the Manufacture and Testing of Therapeutic Products for Human Use Derived From Transgenic AnimalsAugust 22, 1995DoDo
Informed Consent for Plasmapheresis/ImmunizationOctober 1, 1995FDA PersonnelDo
Draft Reviewers' Guide: Changes in PersonnelOctober 1, 1995FDA PersonnelDo
Disease Associated Antibody Collection ProgramOctober 1, 1995FDA PersonnelDo
Guidance Concerning Conversion to FDA-Reviewed Software ProductsNovember 13, 1995FDA Regulated IndustryDo
Donor Deferral Due to Red Blood Cell Loss During Collection of Source Plasma by Automated PlasmapheresisDecember 4, 1995DoDo
Interim Definition and Elimination of Lot-by-Lot Release for Well-Characterized Therapeutic Recombinant DNA-Derived and Monoclonal Antibody Biotechnology ProductsDecember 8, 1995DoDo
Dear Colleague: Regarding Reverse Transcriptase Activity in Viral Vaccines Produced in Chicken CellsJanuary 4, 1996DoDo
Requesting All Manufacturers Immediately to Revise Warning Section for Package Insert on ThrombinJanuary 4, 1996DoDo
ICH Final Guideline: Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Dervied Protein ProductsFebruary 23, 1996DoDo
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ICH Final Guideline on the Need for Long-Term Rodent Carcinogenicity Study of PharmaceuticalsMarch 1, 1996DoDo
Additional Recommendations for Donor Screening With a Licensed Test for HIV-1 AntigenMarch 14, 1996DoDo
FDA Guidance Concerning Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-Derived ProductsMarch 26, 1996DoDo
ICH Guideline on the Detection of Toxicity to Reproduction for Medicinal Products; Addendum on Toxicity to Male FertilityApril 5, 1996DoDo
ICH Guidance on Specific Aspects of Regulatory Genotoxicity Tests for PharmaceuticalsApril 24, 1996DoDo
To Manufacturers of FDA-Regulated Drug/Biological/Device Products, Bovine Spongiform Encephalopathy (BSE)May 9, 1996DoDo
Additional Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leucocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV)May 16, 1996DoDo
Guidance for Industry—The Content and Format for Pediatric Use SupplementsMay 23, 1996DoDo
Guidance on Applications for Products Comprised of Living Autologous Cells Manipulated Ex Vivo and Intended for Structural Repair of ReconstructionMay 24, 1996DoDo
Recommendations and Licensure Requirements for Leukocyte-Reduced Blood ProductsMay 29, 1996DoDo
Guide to Inspections of Infectious Disease Marker Testing FacilitiesJune 1, 1996FDA PersonnelDo
To Manufacturers: Implementation of Testing for Hepatitis C Virus RNA by Manufacturers: Implementation of Testing for Hepatitis C Virus RNA by Polymerase Chain Reaction (PCR) of Intramuscular Immune Globulin PreparationsJune 13, 1996FDA Regulated IndustryDo
ICH Final Guidelines on Stablity Testing of Biotechnological/Biological ProductsJuly 10, 1996
ICH Guideline on Structure and Content of Clinical Study ReportsJuly 17, 1996DoDo
Recommendations for the Quarantine and Disposition of Units From Prior Collections From Donors With Repeatedly Reactive Screening Tests for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human T-Lymphotropic Virus Type I (HTLV-I)July 19, 1996DoDo
To Manufacturers: HIV-1 Group OJuly 31, 1996DoDo
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Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In Vivo UseAugust 15, 1996DoDo
ICH Revised Guidance: Single Dose Acute Toxicity Testing for PharmaceuticalsAugust 26, 1996DoDo
ICH Draft Guideline on Data Elements for Transmission of Individual Case ReportsOctober 1, 1996DoDo
To All Plasma Derivative Manufacturers and to ABRA: Warning Statement for Plasma Derivative Product LabelingOctober 7, 1996DoDo
Advertising and Promotion; Guidance; NoticeOctober 8, 1996DoDo
To Biologic Product Manufacturers: Revised Procedures for Internal Labeling Review Number AssignmentDecember 3, 1996DoDo
Interim Recommendations for Deferral of Donors at Increased Risk for HIV-1 Group O InfectionDecember 11, 1996DoDo
PTC on Plasmid DNA Vaccines for Preventive Infectious Disease IndicationsDecember 22, 1996DoDo
Guidance for the Submission of Chemistry, Manufacturing, and Controls Information and Establishment Description for Autologous Somatic Cell Therapy ProductsJanuary 1997DoDo
Reviewer Guidance for a Premarket Notification Submission for Blood Establishment Computer SoftwareJanuary 13, 1997FDA PersonnelDo
PTC in the Manufacturing and Testing of Monoclonal Antibody Products for Human UseFebruary 28, 1997DoDo
Proposed Approach to Regulation of Cellular and Tissue-Based ProductsFebruary 27, 1997DoDo
Tables 1 and 2 From Proposed Approach to Regulation of Cellular and Tissue-Based ProductsMarch 4, 1997DoDo
Preclearance of Promotional Labeling; ClarificationMarch 5, 1997DoDo
Guidance for Industry for the Evaluation of Combination Vaccines for Preventable Diseases: Production, Testing and Clinical StudiesApril 1997DoDo
ICH Draft Guideline on Dose Selection for Carcinogenicity Studies for Pharmaceuticals: Addendum on the Limit DoseApril 2, 1997DoDo
ICH Draft Guideline on the Timing of Nonclinical Studies for the Conduct of Human Clinical Trials for PharmaceuticalsMay 2, 1997DoDo
ICH Draft Guideline on Impurities: Residual SolventsMay 2, 1997 (Correction May 19, 1997)DoDo
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ICH Guideline on Stability Testing for New Dosage FormsMay 9, 1997DoDo
ICH Draft Guideline on Statistical Principles for Clinical Trials, Part IIIMay 9, 1997DoDo
ICH Good Clinical Practice: Consolidated Guideline, Part IIMay 9, 1997DoDo
ICH Guideline for the Photostability Testing of New Drug Substances and Products, Part IIMay 16, 1997DoDo
ICH Guideline on Impurities in New Drug Products, Part IVMay 19, 1997DoDo
ICH Guideline on Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs, Part VIMay 19, 1997DoDo
ICH Guideline on the Validation of Analytical Procedures: Methodology, Part VMay 19, 1997DoDo
To Plasma Fractionators—CBER's View on Product Recalls Conducted by the Plasma Fractionation IndustryMay 29, 1997DoDo
ICH Draft Guideline on General Considerations for Clinical TrialsMay 30, 1997DoDo
Guide to Inspections of Source Plasma Establishments (Division of Field Investigations, Office of Regional Operations, Office of Regulatory Affairs)June 1, 1997FDA PersonnelDo
Draft Guidance for Industry: Computerized Systems Used in Clinical Trials; AvailabilityJune 18, 1997FDA Regulated IndustryDo
Guidance for Industry—Changes to an Approved Application: Biological ProductsJuly 1997DoDo
Guidance for Industry—Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological ProductsJuly 1997DoDo
Guidance for Industry—Screening and Testing of Donors of Human Tissue Intended for TransplantationJuly 1997DoDo
Guidance for Industry—Donor Screening for Antibodies to HTLV-IIAugust 1997DoDo
Guidance for Industry—Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to ReportAugust 1997DoDo
Draft Guidance for Industry Efficacy Evaluation of Hemoglobin- and Perfluorocarbon-Based Oxygen CarriersSeptember 1997DoDo
Guidance for Industry—The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE) in FDA-Regulated Products for Human UseSeptember 1997DoDo
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Notification Process for Transfusion Related Fatalities and Donation Related Deaths (revised telephone number)October 7, 1997DoDo
Submission Requirements for Requesting Certificates for Exporting Products to Foreign CountriesOctober 15, 1997DoDo
ICH Guidance on Preclinical Safety Evaluation of Biotechnology-Derived PharmaceuticalsNovember 18, 1997DoDo
ICH Guidance on Genotoxicity: A Standard Battery for Genotoxicity Testing for PharmaceuticalsNovember 21, 1997DoDo
ICH Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials for PharmaceuticalsNovember 25, 1997DoDo
Guidance for FDA and Industry: Direct Final Rule ProceduresNovember 21, 1997FDA Personnel and Regulated IndustryDo
Draft Guidance for Industry: Promoting Medical Products in a Changing Healthcare Environment; I. Medical Product Promotion by Healthcare Organizations or Pharmacy Benefits Management Companies (PBMS)December 1997FDA Regulated IndustryDo
Guidance for Industry: Industry-Supported Scientific and Educational ActivitiesDecember 3, 1997DoDo
ICH Guidance on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on a Limit Dose and Related NotesDecember 4, 1997DoDo
To Biologic Product Manufacturers—Withdrawal of Human Blood-Derived Materials Because Donors Diagnosed With, or at Increased Risk for, CJDDecember 11, 1997DoDo
To Allergenic Extract Manufacturers—Standardized Grass Pollen ExtractsDecember 23, 1997DoDo
ICH Guidance on Data Elements for Transmission of Individual Case Safety ReportsJanuary 15, 1998
Guidance for Industry: Year 2000 Date Change for Computer Systems and Software Applications Used in the Manufacture of Blood ProductsJanuary 1998DoDo
Draft Guidance for Industry: Container and Closure Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile ProductsJanuary 1998DoDo
ICH Guidance on Testing for Carcinogenicity of PharmaceuticalsFebruary 28, 1998
Draft Guidance for Industry: Manufacturing, Processing or Holding Active Pharmaceutical IngredientsMarch 1998DoDo
Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene TherapyMarch 1998DoDo
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Draft Guidance for Industry: Instructions for Submitting Electronic Lot Release Protocols to the Center for Biologics Evaluation and ResearchMay 1998DoDo
Draft Guidance for Industry: Pilot Program for Electronic Investigational New Drug (eIND) Applications for Biological ProductsMay 1998DoDo
Guidance for Industry: Classifying Resubmissions in Response to Action LettersMay 1998DoDo
Guidance for Industry: Pharmacokinetics in Patients With Impaired Renal Function—Study Design, Data Analysis and Impact on Dosing and LabelingMay 1998DoDo
Guidance for Industry: Standards for the Prompt Review of Efficacy Supplements, Including Priority Efficacy SupplementsMay 1998DoDo
Guidance for Industry: Providing Clinical Evidence of Effectiveness for Human Drugs and Biological ProductsMay 1998DoDo
Draft Guidance for Industry: Stability Testing of Drug Substances and Drug ProductsJune 1998DoDo
Guidance for Industry: Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic ActJune 1998DoDo
Guidance for Industry: Errors and Accidents Regarding Saline Dilution of Samples Used for Viral Marker TestingJune 1998DoDo
ICH Draft Guidance on Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological ProductsJune 9, 1998DoDo
ICH Guidance on Ethnic Factors in the Acceptability of Foreign Clinical DataJune 10, 1998DoDo
Draft Guidance for Industry: Exports and Imports Under the FDA Export Reform and Enhancement Act of 1996June 12, 1998DoDo
Guidance for Industry: Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997—Elimination of Certain Labeling RequirementsJuly 1998DoDo
Guidance for Industry: Environmental Assessment of Human Drug and Biologics ApplicationsJuly 1998DoDo
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Guidance for Industry: Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition of Units From Prior Collections From Donors With Repeatedly Reactive Screening Tests for Antibody to Hepatitis C Virus (Anti-HCV); (2) Supplemental Testing, and the Notification of Consignees and Blood Recipients of Donor Test Results for Anti-HCVSeptember 1998DoDo
Draft Guidance for Industry: Submitting Debarment Certification StatementsSeptember 1998DoDo
Guidance for Industry: How to Complete the Vaccine Adverse Reporting System Form (VAERS-1)September 1998DoDo
Guidance for Industry: Fast Track Drug Development Programs—Designation, Development, and Application ReviewSeptember 1998DoDo
ICH Guidance on Statistical Principles for Clinical TrialsSeptember 16, 1998DoDo
ICH Guidance on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological ProductsSeptember 21, 1998DoDo
ICH Guidance on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal OriginSeptember 24, 1998DoDo
Guidance for Industry: On Advisory Committees: Implementing Section 120 of the Food and Drug Administration Act of 1997October 1998DoDo
Draft Guidance for Industry: General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological ProductsNovember 1998DoDo
To Viral Vaccine IND Sponsors—Use of PCR-Based Reverse Transcriptase AssayDecember 18, 1998DoDo
Guidance for Industry: FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological ProductsDecember 1998DoDo
Draft Guidance for Industry: Content and Format of Geriatric LabelingDecember 1998DoDo
Draft Guidance for Industry: Product Name Placement, Size and Prominence in Advertising and Promotional LabelingJanuary 1999DoDo
Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related ProductJanuary 1999DoDo
Guidance on Amended Procedures for Advisory Panel MeetingsJanuary 1999DoDo
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Guidance for Industry: Providing Regulatory Submissions in Electronic Format—General ConsiderationsJanuary 1999DoDo
Guidance for Industry: For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Plasma-Derived Biological Products, Animal Plasma or Serum-Derived ProductsFebruary 1999DoDo
Guidance for Industry: Population PharmacokineticsFebruary 1999DoDo
Guidance for Industry: Clinical Development Programs for Drugs, Devices and Biological Products for the Treatment of Rheumatoid Arthritis (RA)February 1999DoDo
Guidance for Industry: For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Plasma-Derived Biological Products, Animal Plasma or Serum-Derived ProductsFebruary 1999DoDo
Draft Guidance for Industry: INDs for Phase 2 and 3 Studies of Drugs, Including Specified Therapeutic Biotechnology-Derived Products, Chemistry, Manufacturing and Controls Content and FormatFebruary 1999DoDo
Draft Guidance for Industry: Accelerated Approval Products—Submission of Promotional MaterialsMarch 1999DoDo
Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Biological In Vitro Diagnostic ProductMarch 1999DoDo
Guidance for Industry: Public Health Issues Posed by the Use of Nonhuman Primate Xenografts in HumansApril 1999DoDo
Guidance for Industry on the Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for an Allergenic Extract or Allergen Patch TestApril 1999DoDo
Guidance for Industry for the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and for the Completion of the Form FDA 356h “Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use”May 1999DoDo
Guidance for Industry for Platelet Testing and Evaluation of Platelet Substitute ProductsMay 1999DoDo
Guidance for Industry: Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured for Commercial UseMay 1999DoDo
Start Printed Page 53851
Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics; Chemistry, Manufacturing, and Controls DocumentationMay 1999DoDo
Draft Guidance for Industry: Establishing Pregnancy RegistriesJune 1999DoDo
Draft Reviewer Guidance: Evaluation of Human Pregnancy Outcome DataJune 1999FDA PersonnelDo
Draft Guidance for Industry: Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition of Prior Collections From Donors With Repeatedly Reactive Screening Tests for Hepatitis C Virus (HCV); (2) Supplemental Testing, and the Notification of Consignees and Transfusion Recipients of Donor Test Results for Antibody to HCV (Anti-HCV)June 1999FDA Regulated IndustryDo
ICH Guidance on the Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing)June 25, 1999DoDo
Draft Guidance for Industry: Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis (OA)July 1999DoDo
Draft Guidance for Industry: Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug RegulationsJuly 1999DoDo
Draft Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed BiologicsAugust 1999DoDo
Guidance for Industry: Consumer-Directed Broadcast AdvertisementsAugust 1999DoDo
Draft Guidance for Industry: Information Request and Discipline Review Letters Under the Prescription Drug User Fee ActAugust 1999DoDo
Guidance for Industry: Possible Dioxin/PCB Contamination of Drug and Biological ProductsAugust 1999DoDo
Guidance for Industry: Submission of Abbreviated Reports and Synopses in Support of Marketing ApplicationsAugust 1999DoDo
ICH Guidance on Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological ProductsAugust 18, 1999DoDo
Draft Guidance for Industry: Revised Recommendations for the Invalidation of Test Results When Using Licensed and 510(k) Cleared Bloodborne Pathogen Assays to Test DonorsSeptember 1999DoDo
Guidance for Industry: Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic ActSeptember 1999DoDo
Start Printed Page 53852
International Conference on Harmonisation Draft Guidance; Choice of Control Group in Clinical TrialsSeptember 24, 1999DoDo
Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format—Biologics Marketing Applications [Biologics License Application (BLA), Product License Application (PLA)/Establishment License Application (ELA) and New Drug Application (NDA)]—RevisedNovember 1999DoDo
Guidance for Industry: Revised Precautionary Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and New Variant Creutzfeldt-Jakob Disease (nvCJD) by Blood and Blood ProductsNovember 1999DoDo
Guidance for Industry: In Vivo Drug Metabolism/Drug Interaction Studies—Study Design, Data Analysis and Recommendations for Dosing and LabelingNovember 1999DoDo
Draft Guidance for Industry: Application of Current Statutory Authority to Nucleic Acid Testing of Pooled PlasmaNovember 1999DoDo
Draft Guidance for Industry: Pharmacokinetics in Patients With Impaired Hepatic Function: Study Design, Data Analysis and Impact on Dosing and LabelingNovember 1999DoDo
International Conference on Harmonsation of Technical Requirements for Registration of Pharmaceuticals for Human Use M4: Common Technical DocumentNovember 8, 1999DoDo
Guidance for Industry: In the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Nucleic Acid Sequences of Human Immunodeficiency Viruses Types 1 and 2December 1999DoDo
Draft Guidance for Industry: Precautionary Measures to Reduce the Possible Risk of Transmission of Zoonoses by Blood and Blood Products From Xenotransplantation Product Recipients and Their ContactsDecember 1999DoDo
Draft Guidance for Industry: Special Protocol AssessmentDecember 1999DoDo
Draft Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further ManufactureJanuary 2000DoDo
Draft Guidance for Reviewers: Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines: A Revised ProtocolFebruary 2000FDA PersonnelDo
Start Printed Page 53853
Draft Guidance for Industry: IND Meetings for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls InformationFebruary 2000FDA Regulated IndustryDo
Guidance for Industry: Formal Meetings With Sponsors and Applicants for PDUFA ProductsFebruary 2000DoDo
Guidance for Industry: Formal Dispute Resolution: Appeals Above the Division LevelFebruary 2000DoDo
Guidance for Industry: Gamma Irradiation of Blood and Blood Components: A Pilot Program for LicensingFebruary 2000DoDo
Draft Guidance for Industry: Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Establishment of a Data BankMarch 2000DoDo
International Conference on Harmonisation; Draft Revised Guidance on Q1A(R) Stability Testing of New Drug Substances and ProductsApril 21, 2000DoDo
Draft Guidance for Industry: Content and Format of the Adverse Reactions Section of Labeling for Human Prescription Drugs and BiologicsMay 2000DoDo
Guidance for Industry: Recognition and Use of a Standard for the Uniform Labeling of Blood and Blood ComponentsJune 2000DoDo
Draft Guidance for Industry: Recommendations for Donor Questioning Regarding Possible Exposure to MalariaJune 2000DoDo
Draft Guidance for Industry: Pediatric Oncology Studies in Response to a Written RequestJune 2000DoDo
Guidance for Industry: Availability of Licensed Donor Screening Tests Labeled for Use With Cadaveric Blood Specimens (Level 2)June 2000DoDo
Draft Guidance for Industry: Chronic Cutaneous Ulcer and Burn Wounds—Developing Products for TreatmentJune 2000DoDo
Draft Guidance for Industry: CBER Pilot Licensing Program for Immunization of Source Plasma Donors Using Immunogen Red Blood Cells Obtained From an Outside SupplierJune 2000DoDo
Draft Guidance for Industry: Developing Medical Imaging Drugs and Biological ProductsJune 2000DoDo
International Conference on Harmonisation (ICH) Draft Guidance; Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (March 17, 2000)June 2000DoDo
International Conference on Harmonisation (ICH) Draft Revised Guidance on Impurities in New Drug ProductsJuly 19, 2000DoDo
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International Conference on Harmonisation (ICH) Draft Revised Guidance on Impurities in New Drug SubstancesJuly 20, 2000DoDo
International Conference on Harmonisation (ICH) Draft Guideline: Organisation of the Common Technical Document for the Registration of Pharmaceuticals for Human UseJuly 20, 2000DoDo
International Conference on Harmonisation (ICH) Draft Guideline on Safety Pharmacology Studies for Human PharmaceuticalsAugust 2000DoDo
Draft Guidance for Industry: Analytical Procedures and Methods Validation—Chemistry, Manufacturing, and Controls DocumentationAugust 2000DoDo
Draft Guidance for Industry: Considerations for Reproductive Toxicity Studies for Preventive Vaccines for Infectious Disease IndicationsAugust 2000DoDo
Guidance for Industry: Q A Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived ProductsOctober 2000DoDo
Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral VectorsOctober 2000DoDo
Guidance for Industry: Submitting and Reviewing Complete Responses to Clinical HoldsOctober 2000DoDo
Draft Guidance for Industry: Cancer Drug and Biological Products—Clinical Data in Marketing ApplicationsNovember 2000DoDo
Guidance for Industry: Testing Limits in Stability Protocols for Standardized Grass Pollen ExtractsNovember 2000DoDo
Guidance for Industry: Use of Sterile Connecting Devices in Blood Bank Practices (Level 2)November 2000DoDo
Draft Guidance for Industry: Recommendations for Complying With the Pediatric Rule (21 CFR 314.55(a) and 601.27(a))November 2000DoDo
International Conference on Harmonisation (ICH) Guidance for Industry: E11 Clinical Investigation of Medicinal Products in the Pediatric PopulationDecember 2000DoDo
Draft Guidance for Industry: Variances for Blood Collection From Individuals With Hereditary HemochromatosisDecember 2000DoDo
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Draft Guidance for Industry: Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User FeesDecember 2000DoDo
International Conference on Harmonisation; Guidance on Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical SubstancesDecember 29, 2000DoDo
PHS Guideline on Infectious Disease Issues in XenotransplantationJanuary 19, 2001DoDo
Draft Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for TransfusionJanuary 2001DoDo
Guidance for Industry: Recommendations for Collecting Red Blood Cells by Automated Apheresis MethodsJanuary 2001DoDo
Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format—Prescription Drug Advertising and Promotional LabelingJanuary 2001DoDo
Draft Guidance for Industry: Source Animal, Product, Preclinical and Clinical Issues Concerning the Use of Xenotransplantation Products in HumansFebruary 2001DoDo
Guidance for Industry: Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods—Technical Correction February 2001February 2001DoDo
Draft Guidance for Industry: Disclosing Information Provided to Advisory Committees in Connection With Open Advisory Committee Meetings Related to the Testing or Approval of Biologic Products and Convened by the Center for Biologics Evaluation and ResearchFebruary 2001DoDo
Draft Guidance for Industry: Postmarketing Safety Reporting for Human Drug and Biological Products Including VaccinesMarch 2001DoDo
Guidance for Industry: Acceptance of Foreign Clinical StudiesMarch 2001DoDo
Guidance for Industry: Financial Disclosure by Clinical InvestigatorsMarch 2001DoDo
Guidance for Industry: Monoclonal Antibodies Used as Reagents in Drug ManufacturingMarch 2001DoDo
Draft Guidance for Industry: Reports on the Status of Postmarketing Studies—Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997April 2001DoDo
Draft Guidance for Industry: Using FDA-Approved Patient Labeling in Consumer-Directed Print AdvertisementsApril 2001DoDo
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Draft Guidance for Industry: Forms for Registration of Producers of Drugs and Listing of Drugs in Commercial DistributionApril 2001DoDo
Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format—Postmarketing Expedited Safety ReportsMay 2001DoDo
Guidance for Industry: E 10 Choice of Control Group and Related Issues in Clinical TrialsMay 2001DoDo
Draft Guidance for Industry: IND Meetings for Human Drugs and Biologics; Chemistry, Manufacturing and Controls InformationMay 2001DoDo

III. Guidance Documents Issued by the Center for Drug Evaluation and Research (CDER)

Name of DocumentDate of IssuanceIntended User or ­Regulatory ActivityHow to Obtain a Hard Copy of the ­Document
Accelerated Approval Products—Submission of Promotional Materials—DraftMarch 26, 1999Advertising Drafthttp://www.fda.gov/​cder/​guidance/​index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Product Name, Placement, Size, and Prominence in Advertising and Promotional Labeling—DraftMarch 12, 1999DoDo
Promoting Medical Products in a Changing Healthcare Environment; Medical Product Promotion by Healthcare Organizations or Pharmacy Management Companies—DraftJanuary 5, 1998DoDo
Using FDA-Approved Patient Labeling in Consumer-Directed Print Advertisements—DraftApril 23, 2001DoDo
Aerosol Steroid Product Safety Information in Prescription Drug Advertising and Promotional LabelingJanuary 12, 1998AdvertisingDo
Consumer-Directed Broadcast AdvertisementsAugust 9, 1999DoDo
Industry-Supported Scientific and Educational ActivitiesDecember 3, 1997DoDo
Antifungal (Topical)—DraftFebruary 24, 1990Biopharmaceutic DraftDo
Antifungal (Vaginal)—DraftFebruary 24, 1990DoDo
Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action—DraftJune 2, 1999DoDo
Conjugated Estrogens, USP: LC-MS Method for Both Qualitative Chemical Characterization and Documentation of Qualitative Pharmaceutical Equivalence—DraftMarch 9, 2000DoDo
Start Printed Page 53857
Food-Effect Bioavailability and Bioequivalence Studies—DraftDecember 30, 1997DoDo
In Vivo Bioequivalence Studies Based on Population and Individual Bioequivalence Studies—DraftDecember 10, 1997DoDo
Topical Dermatological Drug Product NDAs and ANDAs—In Vivo Bioavailability, Bioequivalence, In Vitro Release and Associated Studies—DraftJune 18, 1998DoDo
Bioanalytical Method ValidationMay 23, 2001BiopharmaceuticDo
Bioavailability and Bioequivalence Studies for Orally Administered Drug Products—General ConsiderationsOctober 27, 2000DoDo
Cholestyramine Powder In Vitro BioequivalenceJuly 15, 1993DoDo
Clozapine (Tablets) In Vivo Bioequivalence and In Vitro Dissolution TestingNovember 15, 1996DoDo
Corticosteroids, Detmatologic (Topical) In VivoJune 2, 1995DoDo
Dissolution Testing of Immediate Release Solid Oral Dosage FormsAugust 25, 1997DoDo
Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo CorrelationsSeptember 26, 1997DoDo
Levothyroxine Sodium Tablets—In Vivo Pharmacokinetic and Bioavailability Studies and In Vitro Dissolution TestingMarch 8, 2001DoDo
Metaproterenol Sulfate and Albuterol Metered Dose Inhalers In VitroJune 27, 1989DoDo
Phenytoin/Phenytion Sodium (Capsules, Tablets, Suspension) In Vivo Bioequivalence and In Vitro Dissolution TestingMarch 4, 1994DoDo
Potassium Chloride (Slow-Release Tablets and Capsules) In Vivo Bioequivalence and In Vitro Dissolution TestingJune 6, 1994DoDo
Statistical Approaches to Establishing BioequivalenceFebruary 2, 2001DoDo
Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification SystemAugust 31, 2000DoDo
Analytical Procedures and Methods Validation: Chemistry, Manufacturing, and Controls Documentation—DraftAugust 30, 2000Chemistry DraftDo
Botanical Drug Products—DraftAugust 11, 2000DoDo
INDs for Phase 2 and 3 Studies of Drugs, Including Specified Therapeutic Biotechnology-Derived Products, Chemistry, Manufacturing, and Controls Content and Format—DraftApril 20, 1999DoDo
Start Printed Page 53858
Metered Dose Inhalers (MDI) and Dry Powder Inhalers (DPI) Drug Products; Chemistry, Manufacturing, and Controls Documentation—DraftNovember 19, 1998DoDo
Monoclonal Antibodies Used as Reagents in Drug Manufacturing—DraftJune 24, 1999DoDo
Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products—DraftJune 2, 1999DoDo
Stability Testing of Drug Substances and Drug Products—DraftJune 8, 1998DoDo
Submitting Supporting Chemistry Documentation in Radiopharmaceutical Drug Applications—DraftNovember 1, 1991DoDivision of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
SUPAC-SS: Nonsterile Semisolid Dosage Forms Manufacturing Equipment Addendum—DraftJanuary 5, 1999Dohttp://www.fda.gov/​cder/​guidance/​index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Tracking of NDA and NDA Reformulations for Solid, Oral, Immediate Release Drug Products—DraftApril 12, 1989DoDivision of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
BACPAC1: Intermediates in Drug Substance Synthesis: Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls DocumentationFebruary 16, 2001ChemistryDo
Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological ProductsJuly 24, 1997DoDo
Changes to an Approved NDA or ANDANovember 23, 1999DoDo
Changes to an Approved NDA or ANDA: Questions and AnswersJanuary 22, 2001DoDo
Container Closure Systems for Packaging Human Drugs and BiologicsJuly 7, 1999DoDo
Development of New Stereoisomeric DrugsMay 1, 1992DoDo
Drug Master FilesSeptember 1, 1989DoDo
Drug Master Files for Bulk Antibiotic Drug SubstancesNovember 29, 1999DoDo
Environmental Assessment of Human Drugs and Biologics ApplicationsJuly 27, 1998DoDo
Format and Content for the CMC Section of an Annual ReportSeptember 1, 1994DoDo
Format and Content of the Chemistry, Manufacturing and Controls Section of an ApplicationFebruary 1, 1987DoDo
Start Printed Page 53859
Format and Content of the Microbiology Section of an ApplicationFebruary 1, 1987DoDo
IND Meetings for Human Drugs and Biologics; Chemistry, Manufacturing, and Controls InformationMay 25, 2001DoDo
Monoclonal Antibodies Used as Reagents in Drug ManufacturingMarch 29, 2001DoDo
NDAs: Impurities in Drug SubstancesFebruary 25, 2000DoDo
PAC-ALTS: Postapproval Changes—Analytical Testing Laboratory SitesApril 28, 1998DoDo
Reviewer Guidance: Validation of Chromatographic MethodsNovember 1, 1994DoDo
Submission of Chemistry, Manufacturing, and Controls Information for Synthetic Peptide SubstancesNovember 1, 1994DoDo
Submission of Documentation for Sterilization Process Validation Applications for Human and Veterinary Drug ProductsNovember 1, 1994DoDo
Submitting Documentation for the Manufacturing of and Controls for Drug ProductsFebruary 1, 1987DoDo
Submitting Documentation for the Stability of Human Drugs and BiologicsFebruary 1, 1987DoDo
Submitting Samples and Analytical Data for Methods ValidationFebruary 1, 1987DoDo
Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug ProductsFebruary 1, 1987DoDo
Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug SubstancesFebruary 1, 1987DoDo
SUPAC IR: Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing and In Vivo Bioequivalence DocumentationNovember 30, 1995DoDo
SUPAC IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms, Manufacturing Equipment AddendumFebruary 26, 1999DoDo
SUPAC-IR: Questions and AnswersFebruary 18, 1997DoDo
SUPAC-MR: Modified Release Solid Oral Dosage Forms: Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence DocumentationOctober 6, 1997DoDo
SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Release Testing and In Vivo Bioequivalence DocumentationJune 13, 1997DoDo
Start Printed Page 53860
The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform EncephalopathyDecember 20, 2000DoDo
Acute Bacterial Exacerbation of Chronic Bronchitis; Developing Antimicrobial Drugs for Treatment—DraftJuly 22, 1998Clinical Antimicrobial DraftDo
Acute Bacterial Meningitis; Developing Antimicrobial Drugs for Treatment—DraftJuly 22, 1998DoDo
Acute Bacterial Sinusitis; Developing Antimicrobial Drugs for Treatment—DraftJuly 22, 1998DoDo
Acute or Chronic Bacterial Prostatitis; Developing Antimicrobial Drugs for Treatment—DraftJuly 22, 1998DoDo
Acute Otitis Media; Developing Antimicrobial Drugs for Treatment—DraftJuly 22, 1998DoDo
Bacterial Vaginosis; Developing Antimicrobial Drugs for Treatment—DraftJuly 22, 1998DoDo
Catheter-Related Bloodstream Infections—Developing Antimicrobial Drugs for Treatment—DraftOctober 18, 1999DoDo
Clinical Considerations for Accelerated and Traditional Approval of Antiretroviral Drugs Using Plasma HIV RNA Measurements—DraftSeptember 1, 1999DoDo
Community Acquired Pneumonia; Developing Antimicrobial Drugs for Treatment—DraftJuly 22, 1998DoDo
Complicated Urinary Tract Infections and Pylonephritis; Developing Antimicrobial Drugs for Treatment—DraftJuly 22, 1998DoDo
Developing Antimicrobial Drugs—General Considerations for Clinical Trials—DraftJuly 22, 1998DoDo
Empiric Therapy of Febrile Neutropenia; Developing Antimicrobial Drugs for Treatment—DraftJuly 22, 1998DoDo
Evaluating Clinical Studies of Antimicrobials in the Division of Anti-Infective Drug Products—DraftFebruary 17, 1997DoDo
Lyme Disease; Developing Antimicrobial Drugs for Treatment—DraftJuly 22, 1998DoDo
Nosocomial Pneumonia; Developing Antimicrobial Drugs for Treatment—DraftJuly 22, 1998DoDo
Secondary Bacterial Infections of Acute Bronchitis; Developing Antimicrobial Drugs for Treatment—DraftJuly 22, 1998DoDo
Streptococcal Pharyngitis and Tonsillitis; Developing Antimicrobial Drugs for Treatment—DraftJuly 22, 1998DoDo
Uncomplicated and Complicated Skin and Skin Structure Infections; Developing Antimicrobial Drugs for Treatment—DraftJuly 22, 1998DoDo
Start Printed Page 53861
Uncomplicated Gonorrhea—Cervical, Urethral, Rectal, and/or Pharyngeal; Developing Antimicrobial Drugs for Treatment—DraftJuly 22, 1998DoDo
Uncomplicated Urinary Tract Infections; Developing Antimicrobial Drugs for Treatment—DraftJuly 22, 1998DoDo
Vulvovaginal Candidiasis; Developing Antimicrobial Drugs for Treatment—DraftJuly 22, 1998DoDo
Clinical Development and Labeling of Anti-Infective Drug ProductsOctober 26, 1992Clinical AntimicrobialDo
Clinical Evaluation of Anti-Infective Drugs (Systemic)September 1, 1977DoDo
Preclinical Development of Antiviral DrugsNovember 1, 1990DoDo
Abuse Liability Assessment—DraftJuly 1, 1990Clinical Medical DraftDivision of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Allergic Rhinitis: Clinical Development Programs for Drug Products—DraftJune 21, 2000Dohttp://www.fda.gov/​cder/​guidance/​index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Cancer Drug and Biological Products—Clinical Data in Marketing Applications—DraftNovember 9, 2000DoDo
Chronic Cutaneous Ulcer and Burn Wounds—Developing Products for Treatment—DraftJune 28, 2000DoDo
Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis (OA)—DraftJuly 15, 1999DoDo
Clinical Evaluation of Anti-Anginal Drugs—DraftJanuary 1, 1989DoDivision of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Clinical Evaluation of Anti-Arrhythmic Drugs—DraftJuly 1, 1985Dohttp://www.fda.gov/​cder/​guidance/​index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Clinical Evaluation of Antihypertensive Drugs—DraftMay 1, 1988DoDo
Start Printed Page 53862
Clinical Evaluation of Drugs for the Treatment of Congestive Heart Failure—DraftDecember 1, 1987DoDivision of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Clinical Evaluation of Drugs for Ulcerative Colitis (3rd draft)—DraftJanuary 7, 1991DoDo
Clinical Evaluation of Lipid-Altering Agents In Adults and Children—DraftSeptember 1, 1990Dohttp://www.fda.gov/​cder/​guidance/​index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Clinical Evaluation of Motility-Modifying Drugs—DraftDate not availableDoDivision of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Clinical Evaluation of Weight-Control Drugs—DraftSeptember 24, 1996Dohttp://www.fda.gov/​cder/​guidance/​index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Developing Medical Imaging Drugs and Biologics—Revised—DraftJuly 31, 2000DoDo
Development and Evaluation of Drugs for the Treatment of Psychoactive Substance Use Disorders—DraftFebruary 12, 1992DoDivision of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Development of Parathyroid Hormones for the Prevention and Treatment of Osteoporosis—DraftJune 14, 2000Dohttp://www.fda.gov/​cder/​guidance/​index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Establishing Pregnancy Registries—DraftJune 4, 1999DoDo
Evaluation of Human Pregnancy Outcome Data—DraftJune 4, 1999DoDo
Female Sexual Dysfunction: Clinical Development of Drug Products for Treatment—DraftMay 19, 2000DoDo
Institutional Review Boards, Clinical Investigators, and Sponsors: Exception From Informed Consent Requirements for Emergency Research—DraftMarch 30, 2000DoDo
OTC Treatment of Herpes Labialis With Antiviral Agents—DraftMarch 8, 2000DoDo
Pediatric Oncology Studies in Response to a Written Request—DraftJune 21, 2000DoDo
Start Printed Page 53863
Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines—DraftMarch 12, 2001DoDo
Preclinical and Clinical Evaluation of Agents Used in the Prevention or Treatment of Postmenopausal Osteoporosis—DraftApril 1, 1994DoDo
Preparation of IND Applications for New Drugs Intended for the Treatment of HIV-Infected Individuals—DraftSeptember 1, 1991DoDivision of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Recommendations for Complying With the Pediatric Rule—DraftDecember 4, 2000Dohttp://www.fda.gov/​cder/​guidance/​index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
System Inflammatory Response Syndrome (SIRS) (1st draft)—DraftJuly 1993DoDivision of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Acceptance of Foreign Clinical StudiesMarch 13, 2001Clinical Medicalhttp://www.fda.gov/​cder/​guidance/​index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA)February 17, 1999DoDo
Clinical Development Programs for MDI and DPI Drug ProductsSeptember 19, 1994DoDo
Clinical Evaluation of Analgesic DrugsDecember 1, 1992DoDo
Clinical Evaluation of Antacid DrugsApril 1, 1978DoDo
Clinical Evaluation of Anti-Inflammatory and Antirheumatic Drugs (Adults and Children)April 1, 1988DoDo
Clinical Evaluation of Antianxiety DrugsSeptember 1, 1977DoDo
Clinical Evaluation of Antidepressant DrugsSeptember 1, 1977DoDo
Clinical Evaluation of Antidiarrheal DrugsSeptember 1, 1977DoDo
Clinical Evaluation of Antiepileptic Drugs (Adults and Children)January 1, 1981DoDo
Clinical Evaluation of Combination Estrogen/Progestin-Containing Drug Products Used for Hormone Replacement Therapy of Postmenopausal WomenMarch 20, 1995DoDo
Clinical Evaluation of Gastric Secretory Depressant (GSD) DrugsSeptember 1, 1977DoDo
Start Printed Page 53864
Clinical Evaluation of General AnestheticsMay 1, 1982DoDo
Clinical Evaluation of Hypnotic DrugsSeptember 1, 1977DoDo
Clinical Evaluation of Laxative DrugsApril 1, 1978DoDo
Clinical Evaluation of Local AnestheticsMay 1, 1982DoDo
Clinical Evaluation of Psychoactive Drugs in Infants and ChildrenJuly 1, 1979DoDo
Clinical Evaluation of Radiopharmaceutical DrugsOctober 1, 1981DoDo
Content and Format for Pediatric Use SupplementsMay 24, 1996DoDo
Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived ProductsNovember 20, 1995DoDo
Development of Vaginal Contraceptive Drugs (NDA)April 19, 1995DoDo
FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological ProductsFebruary 2, 1999DoDo
FDA Requirements for Approval of Drugs to Treat Non-Small Lung CancerJanuary 29, 1991DoDo
FDA Requirements for Approval of Drugs to Treat Superficial Bladder CancerJune 20, 1989DoDo
Format and Content of the Clinical and Statistical Sections of an ApplicationJuly 1, 1988DoDo
Format and Content of the Summary for New Drug and Antibiotic ApplicationsFebruary 1, 1987DoDo
Formatting, Assembling and Submitting New Drug and Antibiotic ApplicationsFebruary 1, 1987DoDo
General Considerations for the Clinical Evaluation of DrugsDecember 1, 1978DoDo
General Considerations for the Clinical Evaluation of Drugs in Infants and ChildrenSeptember 1, 1977DoDo
Levothyroxine Sodium Tablets—In Vivo Pharmacokinetic and Bioavailability Studies and In Vitro Dissolution TestingMarch 8, 2001DoDo
Oncologic Drugs Advisory Committee Discussion on FDA Requirements for Approval of New Drugs for Treatment of Ovarian CancerApril 13, 1988DoDo
Oncologic Drugs Advisory Committee Discussion on FDA Requirements for Approval of New Drugs for Treatment of Colon and Rectal CancerApril 19, 1988DoDo
Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products; Clarification of What to ReportAugust 27, 1997DoDo
Start Printed Page 53865
Postmarketing Reporting of Adverse Drug ExperiencesMarch 1, 1992DoDo
Preclinical Development of Immunomodulatory Drugs for the Treatment of HIV Infection and Associated DisordersSeptember 4, 1992DoDo
Preparation of Investigational New Drug Products (Human and Animal)November 1, 1992DoDo
Providing Clinical Evidence of Effectiveness for Human Drug and Biological ProductsMay 15, 1998DoDo
Study and Evaluation of Gender Differences in the Clinical Evaluation of DrugsJuly 22, 1993DoDo
Study of Drugs Likely To Be Used in the ElderlyNovember 1, 1989DoDo
Submission of Abbreviated Reports and Synopses in Support of Marketing ApplicationsSeptember 13, 1999DoDo
General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products—DraftNovember 30, 1998Clinical Pharmacology DraftDo
Pharmacokinetics in Patients With Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling—DraftDecember 7, 1999DoDo
Drug Metabolism/Drug Interaction Studies in the Drug Development Process: Studies In VitroApril 7, 1997Clinical PharmacologyDo
Format and Content of the Human Pharmacokinetics and Bioavailability Section of an ApplicationFebruary 1, 1987DoDo
In Vivo Metabolism/Drug Interaction Studies—Study Design, Data Analysis, and Recommendations for Dosing and LabelingNovember 24, 1999DoDo
Pharmacokinetics and Pharmacodynamics in Patients With Impaired Renal Function: Study Design, Data Analysis, and Impact on Dosing and LabelingMay 15, 1998DoDo
Population PharmacokineticsFebruary 10, 1999DoDo
Guidance for IRBs, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency Research (21 CFR 50.24)—DraftMarch 30, 2000Compliance DraftDo
Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production—DraftSeptember 30, 1998DoDo
Manufacture, Processing or Holding of Active Pharmaceutical Ingredients—DraftApril 17, 1998DoDo
Repacking of Solid Oral Dosage Form Drug Products—DraftFebruary 1, 1992DoDo
Start Printed Page 53866
A Review of FDA’s Implementation of the Drug Export Amendments of 1986ComplianceDo
Compressed Medical GasesDecember 1, 1989DoDo
Computerized Systems Used in Clinical TrialsMay 10, 1999DoDo
Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing IronJune 27, 1997DoDo
General Principles of Process ValidationMay 1, 1987DoDo
Good Laboratory Practice Regulations Questions and AnswersDoDo
Guidance for Hospitals, Nursing Homes, and Other Health Care FacilitiesApril 6, 2001DoDo
Monitoring of Clinical InvestigationsJanuary 1, 1988DoDo
Nuclear Pharmacy Guideline Criteria for Determining When to Register as a Drug EstablishmentMay 1, 1984DoDo
Possible Dioxin/PCB Contamination of Drug and Biological ProductsAugust 23, 1999DoDo
Sterile Drug Products Produced by Aseptic ProcessingMay 1, 1987DoDo
Street Drug AlternativesApril 3, 2000DoDo
Validation of Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical DevicesDecember 1, 1987DoDo
Providing Regulatory Submissions in Electronic Format—Postmarketing Expedited Safety Reports—DraftMay 4, 2001Electronic Submission DraftDo
Providing Regulatory Submissions in Electronic Format: Prescription Drug Advertising and Promotional Labeling—DraftJanuary 31, 2001DoDo
Preparing Data for Electronic Submissions in ANDAsSeptember 23, 1999Electronic SubmissionDo
Regulatory Submissions in Electronic Format; General ConsiderationsJanuary 28, 1999DoDo
Regulatory Submissions in Electronic Format; New Drug ApplicationsJanuary 28, 1999DoDo
ANDAs; Blend Uniformity Analysis—DraftAugust 26, 1999Generic Drug DraftDo
ANDAs; Impurities in Drug Products—DraftJanuary 5, 1999DoDo
Content and Format of an Abbreviated New Drug Application (ANDA)—Positron Emission Tomography (PET) Drug Products—With Specific Information for ANDAs for Fludeoxyglucose F18 Injection—DraftApril 18, 1997DoDo
Alternate Source of Active Pharmaceutical Ingredients in Pending ANDAs—DraftDecember 12, 2000DoDo
Start Printed Page 53867
ANDAs: Impurities in Drug SubstancesDecember 3, 1999Generic DrugsDo
Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic ActMarch 30, 2000DoDo
Letter Announcing That the OGD Will Now Accept the ICH Long-Term Storage Conditions as Well as the Stability Studies Conducted in the PastAugust 18, 1995DoDo
Letter Describing Efforts by CDER and ORA to Clarify the Responsibilities of CDER Chemistry Review Scientists and ORA Field Investigators in the New and Abbreviated Drug Approval Process in Order to Reduce Duplication or Redundancy in the ProcessOctober 14, 1994DoDo
Letter on Incomplete Abbreviated Applications, Convictions Under GDEA, Multiple Supplements, Annual Reports for Bulk Antibiotics, Batch Size for Transdermal Drugs, Bioequivalence Protocols, Research, Deviations From OGD PolicyApril 8, 1994DoDo
Letter on the Provision of New Information Pertaining to New Bioequivalence Guidelines and Refuse-to-File LettersJuly 1, 1992DoDo
Letter on the Provision of New Procedures and Policies Affecting the Generic Drug Review ProcessMarch 15, 1989DoDo
Letter on the Request for Cooperation of Regulated Industry to Improve the Efficiency and Effectiveness of the Generic Drug Review Process, by Assuring the Completeness and Accuracy of Required Information and Data SubmissionsNovember 8, 1991DoDo
Letter on the Response to 12/20/84 Letter From the Pharmaceutical Manufacturers Association About the Drug Price Competition and Patent Term Restoration ActMarch 26, 1985DoDo
Letter to all ANDA and AADA Applicants About the Generic Drug Enforcement Act of 1992 (GDEA), and the Office of Generic Drugs intention to Refuse-to-File Incomplete Submissions as Required by the New LawJanuary 15, 1993DoDo
Letter to Regulated Industry Notifying Interested Parties About Important Detailed Information Regarding Labeling, Scale-up, Packaging, Minor/major Amendment Criteria, and Bioequivalence RequirementsAugust 4, 1993DoDo
Major, Minor, Facsimile, and Telephone Amendments to Original Abbreviated New Drug Applications (Revised)May 1, 2000DoDo
Organization of an ANDAMarch 2, 1999DoDo
Revising ANDA Labeling Following Revision of the RLD LabelingApril 25, 2000DoDo
Start Printed Page 53868
Skin Irritation and Sensitization Testing of Generic Transdermal Drug ProductsFebruary 3, 2000DoDo
Variations in Drug Products That May Be Included ANDAJanuary 27, 1999DoDo
Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review—DraftNovember 22, 1996Good Review Practices DraftDo
Pharmacology/Toxicology Review FormatMay 10, 2001Good Review PracticesDo
Q1A(R)—Stability Testing of New Drug Substances and Products—DraftApril 21, 2000ICH Draft—QualityDo
Q3A(R)—Impurities in New Drug Substances—DraftJuly 20, 2000DoDo
Q3B(R)—Impurities in New Drug Products—DraftJuly 19, 2000DoDo
Q6A—Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances—DraftNovember 25, 1997DoDo
Q7A—Good Manufacturing Practice for Active Pharmaceutical Ingredients—DraftAugust 1, 2000DoDo
S7—Safety Pharmacology Studies for Human Pharmaceuticals—DraftAugust 7, 2000ICH Draft—SafetyDo
E12 A—Principles for Clinical Evaluation of New Antihypertensive Drugs—DraftAugust 9, 2000ICH Draft—EfficacyDo
M4—Common Technical Document—DraftAugust 24, 2000ICH Draft—Joint Safety/Efficacy (Multidisciplinary)Do
Q1A—Stability Testing of New Drug Substances and ProductsSeptember 22, 1994ICH—QualityDo
QIB—Photostability Testing of New Drug Substances and ProductsMay 16, 1997DoDo
QIC—Stability Testing for New Dosage FormsMay 9, 1997DoDo
Q2A—Text on Validation of Analytical ProceduresMarch 1, 1995DoDo
Q2B—Validation of Analytical Procedures: MethodologyMay 19, 1997DoDo
Q3A—Impurities in New Drug SubstancesJanuary 4, 1996DoDo
Q3B(R)— Impurities in New Drug ProductsJuly 19, 2000DoDo
Q3C—Impurities: Residual SolventsDecember 24, 1997DoDo
Q5A—Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal OriginSeptember 24, 1998DoDo
Q5B—Quality of Biotechnology Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein ProductsFebruary 23, 1996DoDo
Start Printed Page 53869
Q5C—Quality of Biotechnological Products: Stability Testing of Biotechnology/Biological ProductsJuly 10, 1996DoDo
Q5D—Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological ProductsSeptember 21, 1998DoDo
Q6A—Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical SubstancesDecember 29, 2000DoDo
Q6B—Test Procedures and Acceptance Criteria for Biotechnological/Biological ProductsAugust 18, 1999DoDo
S1A—The Need for Long-Term Rodent Carcinogenicity Studies of PharmaceuticalsMarch 1, 1996ICH—SafetyDo
S1B—Testing for Carcinogenicity in PharmaceuticalsFebruary 23, 1998DoDo
S1C—Dose Selection for Carcinogenicity Studies of PharmaceuticalsMarch 1, 1995DoDo
S1C(R)—Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on a Limit Dose and Related NotesDecember 4, 1997DoDo
S2A—Specific Aspects of Regulatory Genotoxicity Tests for PharmaceuticalsApril 24, 1996DoDo
S2B—Genotoxicity: Standard Battery TestingNovember 21, 1997DoDo
S3A—Toxicokinetics: The Assessment of Systemic Exposure in Toxicity StudiesMarch 1, 1995DoDo
S3B—Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution StudiesMarch 1, 1995DoDo
S4A—Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing)June 25, 1999DoDo
S5A—Detection of Toxicity to Reproduction for Medicinal ProductsSeptember 22, 1994DoDo
S5B—Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male FertilityApril 5, 1996DoDo
S6—Preclinical Safety Evaluation of Biotechnology-Derived PharmaceuticalsNovember 18, 1997DoDo
S7A—Safety Pharmacology Studies for Human PharmaceuticalsJuly 13, 2001DoDo
EIA—The Extent of Population Exposure to Assess Clinical Safety: for Drugs Intended for Long-Term Treatment of Non-Life-Threatening ConditionsMarch 1, 1995ICH—EfficacyDo
E2A—Clinical Safety Data Management: Definitions and Standards for Expedited ReportingMarch 1, 1995DoDo
Start Printed Page 53870
E2B—Data Elements for Transmission of Individual Case Safety ReportsJanuary 15, 1998DoDo
E2C—Clinical Safety Data Management: Periodic Safety Update Reports for Marketed DrugsMay 19, 1997DoDo
E3—Structure and Content of Clinical Study ReportsJuly 17, 1996DoDo
E4—Dose-Response Information to Support Drug RegistrationNovember 9, 1994DoDo
E5—Ethnic Factors in the Acceptability of Foreign Clinical DataJune 10, 1998DoDo
E6—Good Clinical Practice: Consolidated GuidelineMay 9, 1997DoDo
E7—Studies in Support of Special Populations: GeriatricsAugust 2, 1994DoDo
E8—General Considerations for Clinical TrialsDecember 24, 1997DoDo
E9—Statistical Principles for Clinical TrialsSeptember 16, 1998DoDo
E10—International Conference on Harmonisation: Choice of Control Group and Related Issues in Clinical TrialsMay 14, 2001DoDo
E11—Clinical Investigation of Medicinal Products in the Pediatric PopulationDecember 15, 2000DoDo
M3—Nonclinical Safety Studies for the Conduct of Human Clinical Trials for PharmaceuticalsNovember 25, 1997ICH—Joint Safety/Efficacy (Multidisciplinary)Do
A Revision in Sample Collection Under the Compliance Program Pertaining to Pre-Approval InspectionsJuly 15, 1996Industry LettersDivision of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Certification Requirements for Debarred Individuals in Drug ApplicationsJune 1, 1990DoDo
Continuation of a Series of Letters Communicating Interim and Informal Generic Drug Policy and Guidance. Availability of Policy and Procedure Guides, and Further Operational Changes to the Generic Drug Review ProgramMarch 2, 1998DoHttp://www.fda.gov/​cder/​guidance/​index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Fifth of a Series of Letters Providing Informal Notice About the Act, Discussing the Statutory Mechanism by Which ANDA Applicants May Make Modifications in Approved Drugs Where Clinical Data Is RequiredApril 10, 1987DoDo
Fourth of a Series of Letters Providing Informal Notice to Affected Parties About Policy Developments and Interpretations Regarding the Act. Three-Year Exclusivity Provisions of Title 1October 31, 1986DoDo
Start Printed Page 53871
Implementation of the Drug Price Competition and Patent Term Restoration Act; Preliminary GuidanceOctober 11, 1984DoDo
Implementation Plan USP Injection NomenclatureOctober 2, 1995DoDo
Instructions for Filing Supplements Under the Provisions of SUPAC-IRApril 11, 1996DoDivision of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Seventh of a Series of Letters About the Act Providing Guidance on the “180-Day Exclusivity” Provision of Section 505(j)(4)(B)(iv) of the ActJuly 29, 1988DoHttp://www.fda.gov/​cder/​guidance/​index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Sixth of a Series of Informal Notice Letters About the Act Discussing 3- and 5-year Exclusivity Provisions of Section 505(c)(3)(D) and (j)(4)(D) of the ActApril 28, 1988DoDo
Streamlining InitiativeDecember 24, 1996DoDivision of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Supplement to 10/11/84 Letter About Policies, Procedures and Implementation of the Act (Q A Format)November 16, 1984Dohttp://www.fda.gov/​cder/​guidance/​index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Third of a Series of Letters Regarding the Implementation of the ActMay 1, 1985DoDo
Y2K Letter From Dr. Janet WoodcockOctober 19, 1998DoDo
Combined Oral Contraceptives—Labeling for Healthcare Providers and Patients—DraftJuly 10, 2000Labeling DraftDo
Content and Format for Geriatric Labeling—DraftJanuary 21, 1999DoDo
Content and Format of the Adverse Reactions Section of Labeling for Human Prescription Drugs and Biologics—DraftJune 21, 2000DoDo
Non-Contraceptive Estrogen Drug Products—Physician and Patient Labeling—DraftJanuary 8, 1999DoDo
Noncontraceptive Estrogen Class Labeling—DraftSeptember 27, 1999DoDo
Labeling of OTC Topical Drug Products for the Treatment of Vaginal Yeast Infections (Vulvovaginal Candidiasis)—DraftJuly 16, 1998DoDo
Start Printed Page 53872
Referencing Discontinued Labeling for Listed Drugs in Abbreviated New Drug Applications—DraftOctober 26, 2000DoDo
Therapeutic Equivalence Code Placement on Prescription Drug Labels and Labeling—DraftJanuary 28, 1999DoDo
Acetaminophen and Codeine Phosphate Tablets/CapsulesDecember 1, 1993LabelingDo
Acetaminophen and Codeine Phosphate Oral Solution/SuspensionDecember 1, 1993DoDo
Acetaminophen, Aspirin and Codeine Phosphate Tablets/CapsulesDecember 1, 1993DoDo
Alprazolam Tablets USPAugust 1, 1996DoDo
Amiloride Hydrochloride and Hydrochlorothiazide Tablets USPSeptember 1, 1997DoDo
Amlodipine Besylate TabletsSeptember 1, 1997DoDo
Astemizole TabletsSeptember 1, 1997DoDo
Atenolol Tablets USPAugust 1, 1997DoDo
Barbiturate, Single Entity-Class LabelingMarch 1, 1981DoDivision of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Butalbital, Acetaminophen and Caffeine Capsules/Tablets USPSeptember 1, 1997Dohttp://www.fda.gov/​cder/​guidance/​index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Butalbital, Acetaminophen, Caffeine and Hydocodone Bitartrate TabletsSeptember 21, 1997DoDo
Butorphanol Tartrate Injection USPOctober 1, 1992DoDo
Captopril and Hydrochlorothiazide Tablets USPApril 1, 1995DoDo
Captopril TabletsFebruary 1, 1995DoDo
Carbidopa and Levodopa Tablets USPFebruary 1, 1992DoDo
Chlordiazepoxide Hydrochloride CapsulesJanuary 1, 1988DoDo
Cimetidine Hydrochloride InjectionSeptember 1, 1995DoDo
Cimetidine TabletsSeptember 1, 1995DoDo
Cisapride Oral SuspensionSeptember 1, 1997DoDo
Cisapride TabletsSeptember 1, 1997DoDo
Clindamycin Phosphate Injection USPSeptember 1, 1998DoDo
Start Printed Page 53873
Clorazepate Dipotassium Capsules/TabletsMarch 1, 1993DoDivision of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Combination Oral Contraceptives—Physician and Patient LabelingJanuary 1, 1994DoDo
Cyproheptadine Hydrochloride Tablets/SyrupDecember 1, 1986DoDo
Diclofenac Sodium Delayed-Release TabletsJanuary 1, 1997Dohttp://www.fda.gov/​cder/​guidance/​index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Diltiazem Hydrochloride Extended-Release CapsulesSeptember 1, 1995DoDo
Diphenoxylate Hydrochloride and Atropine Sulfate Oral Solution USPApril 1, 1995DoDo
Diphenoxylate Hydrochloride and Atropine Sulfate Tablets USPApril 1, 1995DoDo
Dipivefrin Hydrochloride Ophthalmic Solution, 0.1%November 2, 1998DoDivision of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Ergoloid Mesylates TabletsJanuary 1, 1988DoDo
Fludeoxyglucose F18 InjectionJanuary 1, 1997Dohttp://www.fda.gov/​cder/​guidance/​index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Flurbiprofen Tablets USPJanuary 1, 1994DoDo
Fluvoxamine Maleate TabletsSeptember 1, 1997DoDo
Gentamicin Sulfate Ophthalmic Ointment and Solution USPApril 1, 1992DoDo
Heparin Sodium Injection USPMarch 1, 1991DoDo
Hydrocodone Bitartrate and Acetaminophen Tablets USPApril 1, 1994DoDo
Hydroxyzine Hydrochloride InjectionDecember 1, 1989DoDivision of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Hypoglycemic Oral Agents Federal RegisterApril 1, 1984DoDo
Start Printed Page 53874
Indomethacin Capsules USPSeptember 1, 1995Dohttp://www.fda.gov/​cder/​guidance/​index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Informal Labeling Guidance Texts for Estrogen Drug Products Patient LabelingAugust 1, 1992DoDivision of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Informal Labeling Guidance Texts for Estrogen Drug Products: Professional LabelingAugust 1, 1992DoDo
Isoetharine Inhalation SolutionMarch 1, 1989DoDo
Itraconazole Capsules, USPSeptember 1, 1998Dohttp://www.fda.gov/​cder/​guidance/​index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Leucovorin Calcium for InjectionJuly 1, 1996DoDo
Leucovorin Calcium Tablets, USPJuly 1, 1996DoDo
Local Anesthetics Class LabelingSeptember 1, 1982DoDivision of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Meclofenamate Sodium CapsulesJuly 1, 1992DoDo
Medroxyprogesterone Acetate Tablets, USPSeptember 1, 1998Dohttp://www.fda.gov/​cder/​guidance/​index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Metaproterenol Sulfate Inhalation Solution USPMay 1, 1992DoDo
Metaproterenol Sulfate Syrup USPMay 1, 1992DoDo
Metaproterenol Sulfate TabletsMay 1, 1992DoDo
Metoclopramide Tablets USP/Oral SolutionFebruary 1, 1995DoDo
Naphazoline Hydrochloride Ophthalmic SolutionMarch 1, 1989DoDivision of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Start Printed Page 53875
Naproxen Sodium Tablets, USPSeptember 1, 1997Dohttp://www.fda.gov/​cder/​guidance/​index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Naproxen Tablets, USPSeptember 1, 1997DoDo
Niacin TabletsJuly 1, 1982DoDivision of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Paclitaxel InjectionSeptember 1, 1997Dohttp://www.fda.gov/​cder/​guidance/​index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Phendimetrazine Tartrate Capsules/T Nets, and Extended-Release CapsulesFebruary 1, 1991DoDivision of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Phentermine Hydrochloride Capsules/TabletsAugust 1, 1988DoDo
Promethazine Hydrochloride TabletsMarch 1, 1990DoDo
Propantheline Bromide TabletsAugust 1, 1988DoDo
Pyridoxine Hydrochloride InjectionJune 1, 1984DoDo
Quinidine Sulfate Tablets/Capsules USPOctober 1, 1995Dohttp://www.fda.gov/​cder/​guidance/​index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Ranitidine Tablets USPNovember 1, 1993DoDo
Risperidone Oral SolutionSeptember 1, 1997DoDo
Risperidone TabletsSeptember 1, 1997DoDo
Sulfacetainide Sodium and Prednisolone Acetate Ophthalmic Suspension and OintmentJanuary 1, 1995DoDo
Sulfacetamide Sodium Ophthalmic Solution/OintmentAugust 1, 1992DoDo
Sulfamethoxazole and Phenazopyridine Hydrochloride TabletsFebruary 1, 1992DoDivision of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Start Printed Page 53876
Sulfamethoxazole and Trimethoprim Tablets and Oral SuspensionAugust 1, 1993Dohttp://www.fda.gov/​cder/​guidance/​index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Theophylline Immediate-Release Dosage FormsFebruary 1, 1995DoDivision of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Theophylline Intravenous Dosage FormsSeptember 1, 1995Dohttp://www.fda.gov/​cder/​guidance/​index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Thiamine Hydrochloride InjectionFebruary 1, 1988DoDivision of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Tobramycin Sulfate Injection USPMay 1, 1993Dohttp://www.fda.gov/​cder/​guidance/​index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
Venlafaxine Hydrochloride TabletsOctober 1, 1997DoDo
Verapamil Hydrochloride TabletsOctober 1, 1991DoDo
Vitamin A CapsulesFebruary 1, 1992DoDo
Zolpidem Tartrate TabletsSeptember 1, 1997DoDo
Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-Derived ProductsApril 1, 1996MicrobiologyDo
Labeling OTC Human Drug Products—Submitting Requests for Exemptions and Deferrals—DraftDecember 19, 2000OTC DraftDo
Labeling OTC Human Drug Products: Updating Labeling in ANDAs—DraftFebruary 22, 2001DoDo
OTC Actual Use Studies—DraftJuly 22, 1994DoDivision of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
OTC Nicotine Substitutes—DraftMarch 1, 1994DoDo
Start Printed Page 53877
Enforcement Policy on Marketing OTC Combination Products (CPG 7132b.16)OTChttp://www.fda.gov/​cder/​guidance/​index.htm Division of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573
General Guidelines for OTC Combination ProductsDoDo
Labeling OCT Human Drug Products Using a Column FormatDecember 19, 2000DoDo
Upgrading Category III Antiperspirants to Category 1 (43 FR 46728-46731)DoDo
Carcinogenicity Study Protocol Submissions—DraftNovember 7, 2000Pharmacology/Toxicology DraftDo
Immunotoxicology Evaluation of Investigational New Drugs—DraftMay 11, 2001DoDo
Photosafety Testing—DraftJanuary 10, 2000DoDo
Statistical Aspects of the Design, Analysis, and Interpretation of Chronic Rodent Carcinogenicity Studies of Pharmaceuticals—DraftMay 8, 2001DoDo
Content and Format of INDs for Phase 1 Studies of Drugs Including Well-Characterized, Therapeutic, Biotechnology-Derived ProductsOctober 4, 2000Pharmacology/ToxicologyDo
Format and Content of the Nonclinical Pharmacology/Toxicology Section of an ApplicationFebruary 1, 1987DoDo
Nonclinical Pharmacology/Toxicology Development of Topical Drugs Intended to Prevent the Transmission of Sexually Transmitted Diseases (STD) and/or for the Development of Drugs Intended to Act as Vaginal ContraceptivesOctober 16, 1996DoDo
Reference Guide for the Nonclinical Toxicity Studies of Antiviral Drugs Indicated for the Treatment of N/A Non-Life Threatening Disease: Evaluation of Drug Toxicity Prior to Phase I Clinical StudiesFebruary 1, 1989DoDo
Single Dose Acute Toxicity Testing Toxicity Testing for PharmaceuticalsAugust 26, 1996DoDo
Applications Covered by Section 505(b)(2)—DraftDecember 8, 1999Procedural DraftDo
Content and Format of New Drug Applications and Abbreviated New Drug Applications for Certain Positron Emission Tomography Drug Products—DraftMarch 10, 2000DoDo
Disclosing Information Provided to Advisory Committees in Connection With Open Advisory Committee Meetings Related to the Testing or Approval of New Drugs and Convened by CDER, Beginning January 1, 2000—DraftDecember 22, 1999DoDo
Start Printed Page 53878
Forms for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution—DraftMay 15, 2001DoDo
Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Establishment of a Data Bank—DraftMarch 29, 2000DoDo
Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Implementation Plan—DraftJuly 9, 2001DoDo
Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act—DraftAugust 17, 1999DoDo
PET Drug Applications—Content and Format for NDAs and ANDAs—DraftMarch 10, 2000DoDo
Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines—DraftMarch 12, 2001DoDo
Potassium Iodide as a Thyroid Blocking Agent in Radiation Emergencies—DraftJanuary 4, 2001DoDo
Reports on the Status of Postmarketing Studies—Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997—DraftApril 4, 2001DoDo
Special Protocol Assessment—DraftFebruary 9, 2000DoDo
Submitting Debarment Certification Statements—DraftOctober 2, 1998DoDo
180-Day Generic Drug Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic ActJuly 14, 1998ProceduralDo
Advisory Committees: Implementing Section 120 of the Food and Drug Modernization Act of 1997November 2, 1998DoDo
Court Decisions, ANDA Approvals, and 130-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic ActMarch 30, 2000DoDo
Disclosure of Materials Provided to Advisory Committees in Connection With Open Advisory Committee Meetings Convened by the Center for Drug Evaluation and Research Beginning on January 1, 2000November 30, 1999DoDo
Enforcement Policy During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic ActNovember 23, 1998DoDo
Fast Track Drug Development Programs: Designation, Development, and Application ReviewNovember 18, 1998DoDo
Financial Disclosure by Clinical InvestigatorsMarch 20, 2001DoDo
Formal Dispute Resolution: Appeals Above the Division LevelMarch 7, 2000DoDo
Start Printed Page 53879
Formal Meetings With Sponsors and Applicants for PDUFA ProductsMarch 7, 2000DoDo
Implementation of Section 120 of the FDA Modernization Act of 1997—Advisory CommitteesNovember 20, 1998DoDo
Implementation of Section 126 of the FDA Modernization Act of 1997—Elimination of Certain Labeling RequirementsJuly 21, 1998DoDo
Levothyroxine Sodium Products—Enforcement of August 14, 2001, Compliance Date and Submission of New ApplicationsJuly 13, 2001DoDo
National Uniformity for Nonprescription Drugs Ingredient Labeling for OTC DrugsApril 9, 1998DoDo
Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act—RevisedOctober 1, 1999DoDo
Reduction of Civil Money Penalties for Small Business EntitiesMarch 20, 2001DoDo
Refusal to FileJuly 12, 1993DoDo
Repeal of Section 507 of the Federal Food, Drug, and Cosmetic ActJune 15, 1998DoDo
Standards for the Prompt Review of Efficacy Supplements Including Priority Efficacy SupplementsMay 15, 1998DoDo
Women and Minorities Guidance RequirementsJuly 20, 1998DoDo
Information Request and Discipline Review Letters Under the Prescription Drug User Fee ActAugust 17, 1999User Fee DraftDo
Submitting Separate Marketing Applications and Definitions of Clinical Data for Purposes of Assessing User Fees—DraftFebruary 22, 2001DoDo
Waivers of and Reductions in User Fees (Attachment G)—DraftJuly 16, 1993DoDo
Applicability of User Fees to: (1) Applications Withdrawn Before Filing Decision, or (2) Applications the Agency Has Refused to File and That Are Resubmitted or Filed Over Protest (Attachment F)July 12, 1993User FeeDo
Application, Product, and Establishment Fees: Common Issues and Their Resolution (Attachment D)December 16, 1994DoDo
Classifying Resubmissions in Response to Action LettersMay 14, 1998DoDo
Fees-Exceed-the-Costs Waivers Under the Prescription Drug User Fee ActAugust 25, 1999DoDo
Formal Meetings With Sponsors and Applicants for PDUFA ProductsMarch 7, 2000DoDo
Submitting and Reviewing Complete Responses to Clinical Holds (Revised)October 26, 2000DoDo
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Withdrawals

Name of DocumentDate of IssuanceIntended User or ­Regulatory ActivityDate of Withdrawal
Dissemination and Reprints of Certain Published Original Data (No Replacement)October 8, 1996AdvertisingFebruary 16, 2000
Funded Dissemination of Reference Texts (No Replacement)October 8, 1996AdvertisingFebruary 16, 2000
Buspirone Hydrochloride Tablets In Vivo Bioequivalence (No Replacement)May 14, 1998BiopharmaceuticsNovember 30, 2000
Cimetidine Tablets In Vivo Bioequivalence and In Vitro Dissolution (No Replacement)UnknownBiopharmaceuticsNovember 30, 2000
Diclofenac Sodium (Tablets) In Vivo Bioequivalence and In Vitro Dissolution Testing (No Replacement)October 6, 1994BiopharmaceuticsNovember 30, 2000
Glipizide In Vivo Bioequivalence and In Vivo Dissolution Testing (No Replacement)UnknownBiopharmaceuticsNovember 30, 2000
Glyburide In Vivo Bioequivalence and In Vivo Dissolution Testing (No Replacement)UnknownBiopharmaceuticsNovember 30, 2000
Oral Extended (Controlled) Release Dosage Forms In Vivo Bioequivalence and In Vitro Dissolution Testing (No Replacement)UnknownBiopharmaceuticsNovember 30, 2000
Statistical Procedures for Bioequivalence Studies Using a Standard Two-Treatment Crossover Design (No Replacement)July 1, 1992BiopharmaceuticsNovember 30, 2000
Clinical Evaluation of Drugs to Prevent Dental Caries (No Replacement)November 1, 1978Clinical MedicalMay 18, 2000
Clinical Evaluation of Drugs to Prevent, Control, and/or Treat Periodontal Disease (No Replacement)November 1, 1978Clinical MedicalMay 18, 2000
OTC Treatment of Hypercholesterolemia (No Replacement)October 27, 1997OTCAugust 3, 2000
Levothyroxine Sodium: Questions and Answers (Replaced by Levothyroxine Sodium Products Enforcement of August 14, 2001, Compliance Date and Submission of New Applications issued on July 13, 2001)March 8, 2001ProceduralJuly 13, 2001

IV. Guidance Documents Issued by the Center for Devices and Radiological Health (CDRH)

Name of DocumentDate of IssuanceIntended User or ­Regulatory ActivityHow to Obtain a Hard Copy of the Document (Name and Address, Phone, FAX, E-mail or Internet)FOD No.
The FDA Export Reform and Enhancement Act of 1996/Export Certification Package Including “Instructions for Requests for Certificate to Foreign Governments”February 7, 2000Office of Compliance (OC)Division of Small Manufacturers Assistance; 1-800-638-2041 or 301-827-0111 or (FAX) Facts-on-Demand (FOD) at 1-800-899-0381 or Internet at http://www.fda.gov/​ cdrh/ggpmain.html865
Commercial Distribution/Exhibit LetterApril 10, 1992OCDo246
Color Additive Status List (Inspection Operations Manual)February 1, 1989OCDo268
FDA Guide for Validation of Biological Indicator Incubation TimeJanuary 1, 1986OCDo283
Start Printed Page 53881
Guide for Establishing and Maintaining a Calibration Constancy Intercomparison System for Microwave Oven Compliance Survey Instruments (FDA 88-8264)March 1, 1988OCDo286
Preproduction Quality Assurance Planning: Recommendations for Medical Device Manufacturers (FDA 90-4236)September 1, 1989OCDo295
Color Additive Petitions (p. 11-19 of PMA Manual)June 1, 1987OCDo296
Guidance for Preparation of PMA Manufacturing InformationAugust 1, 1992OCDo448
Civil Money Penalty Policy; Guidance for FDA StaffJune 8, 1999OCDo1124
General Principles of Software Validation; Draft GuidanceJune 9, 1997OCDo938
Classification Names for Medical Devices and In Vitro Diagnostic Products (FDA Pub. No. 95-4246)March 1, 1995OCDo10
Cover Letter/Guidance Document on the Performance Standard for Electrode Lead Wires and Patient CableMarch 9, 1998OCDo1197
Guidance on Medical Device Tracking [FDAMA]; Guidance for Industry and FDA StaffJanuary 24, 2000OCDo169
Compliance Program Guidance Manual: Inspection of Medical Devices; DraftAugust 12, 1999OCDo1702
Procedures for Laboratory Compliance Testing of Television Receivers—Part of TV PacketMay 1, 1986OCDo945
Sec. 300.600 Commercial Distribution with Regard to Premarket Notification [510(k)] [CPG 7124.19]September 24, 1987OCDo181
Letter to Medical Device Manufacturer on Pentium ProcessorsFebruary 14, 1995OCDo456
Implementation of the Biomaterials Access Assurance Act of 1998April 2, 2001OCDo1324
Guideline for the Monitoring of Clinical InvestigationsJanuary 1, 1988OCDo428
Regulating In Vitro Diagnostic Device (IVD) Studies; Guidance for FDA StaffDecember 17, 1999OC/Division of Bioresearch Monitoring (DBM)Do1132
Preparing Notices of Availability of Investigational Medical Devices and for Recruiting Study SubjectsMarch 19, 1999OC/DBMDo2229
Guidance on Electrosurgical Devices and the Application of the Performance Standard for Electrode Lead Wires and Patient CablesNovember 15, 1999OC/Division of Enforcement (DOE) IDo1129
Guidance on Quality System Regulation Information for Various Premarket Submissions; DraftAugust 3, 1999OC/DOEIIDo1140
Surveillance and Detention Without Physical Examination of Surgeons’ and/or Patient Examination Gloves; Guidance for Industry—DraftJuly 26, 2000OC/DOEIIDo1141
Manufacturers/Assemblers of Diagnostic X-Ray Systems: Enforcement Policy for Positive-Beam Limitation (PBL) Requirements in 21 CFR 1020.31(g)October 13, 1993OC/DOEIDo116
Guide for the Submission of Initial Reports on Diagnostic X-Ray Systems and their Major ComponentsJanuary 1, 1982OC/DOEIDo257
Start Printed Page 53882
Exemption From Reporting and Recordkeeping Requirements for Certain Sunlamp Product ManufacturersSeptember 16, 1981OC/DOEIDo343
Letter to Medical Device Industry on Endoscopy and Laparoscopy Accessories (Galdi)May 17, 1993OC/DOEIDo545
Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (FDA 89-8221)March 1, 1989OC/DOEIDo758
CPG 7133.19: Retention of Microwave Oven Test Record/Cover Letter: 08/24, 1981 Retention of Records Required by 21 CFR [Part] 1002March 1, 1995OC/DOEIDo880
Guideline for the Manufacture of In Vitro Diagnostic ProductsJanuary 10, 1994OC/DOEIDo918
A Guide for the Submission of Abbreviated Radiation Safety Reports on Cephalometric X-Ray Devices: Defined as Dental Units With an Attachment for Mandible Work That Holds a Cassette and Beam Limiting DeviceMarch 1, 1996OC/DOEIDo977
A Guide for the Submission of an Abbreviated Radiation Safety Report on X-Ray Tables, Cradles, Film Changers or Cassette Holders Intended for Diagnostic UseMarch 1, 1996OC/DOEIDo978
A Guide for the Submission of Abbreviated Radiation Safety Reports on Image Receptor Support Devices for Mammographic X-Ray SystemsMarch 1, 1996OC/DOEIDo979
Compliance Program Guidance Manual; Field Compliance Testing of Diagnostic (Medical) X-Ray Equipment; Guidance for FDA StaffMarch 15, 2000OC/DOEIDo1133
Information Disclosure by Manufacturers to Assemblers for Diagnostic X-Ray Systems; Final Guidance for Industry and FDAApril 2, 2001OC/DOEIDo2619
Guide for Submission of Information on Accelerators Intended to Emit X-Radiation Required Pursuant to 21 CFR 1002.10April 1, 1971OC/DOEIIIIDo235
Abbreviated Reports on Radiation Safety for Microwave Products (Other Than Microwave Ovens)—E.G. Microwave Heating, Microwave Diathermy, RF Sealers, Induction, Dielectric Heaters, Security SystemsAugust 1, 1995OC/DOEIIIIDo236
Guide for Preparing Reports on Radiation Safety of Microwave OvensMarch 1, 1985OC/DOEIIIIDo239
Reporting Guide for Laser Light Shows and Displays (21 CFR [Part] 1002) (FDA 88-8140)September 1, 1995OC/DOEIIIIDo251
Guide for Filing Annual Reports for X-Ray Components and SystemsJuly 1, 1980OC/DOEIIIIDo253
Reporting and Compliance Guide for Television Products Including Product Report, Supplemental Report, Radiation Safety Abbreviated Report, Annual Report, Information and GuidanceOctober 1, 1995OC/DOEIIIIDo260
Revised Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show Products (Replaces FDA 82-8127)September 1, 1995OC/DOEIIIIDo264
Start Printed Page 53883
Guide for Preparing Abbreviated Reports of Microwave and RF Emitting Electronic Products Intended for Medical UseSeptember 1, 1996OC/DOEIIIIDo399
Letter to Manufacturers and Importers of Microwave Ovens: Information Requirements for Cookbooks and User and Service ManualsOctober 31, 1988OC/DOEIIIIDo697
Abbreviated Reports on Radiation Safety of Non-Medical Ultrasonic ProductsAugust 1, 1995OC/DOEIIIIDo951
Guide for Preparing Product Reports for Medical Ultrasound ProductsSeptember 1, 1996OC/DOEIIIIDo960
Letter—Manufacturers, Distributors and Importers of Condom ProductsFebruary 23, 1994OC/DOEIIDo52
Letter—Manufacturers, Importers, and Repackagers of Condoms for Contraception or Sexually-Transmitted Disease Prevention (Holt)February 13, 1989OC/DOEIIDo53
Letter—Condom Manufacturers and DistributorsApril 5, 1994OC/DOEIIDo56
Letter to Manufacturers/Repackers Using CottonApril 22, 1994OC/DOEIIDo101
Guide for Preparing Product Reports for Lasers and Products Containing LasersSeptember 1, 1995OC/DOEIIDo277
Compliance Guide for Laser Products (FDA 86-8260)September 1, 1985OC/DOEIIDo278
Condoms: Inspection and Sampling at Domestic Manufacturers and of All Repackers; Sampling From All Importers (Damaska Memo to Field on 4/8, 1987)April 8, 1987OC/DOEIIDo293
Dental Handpiece Sterilization (Dear Doctor Letter)September 28, 1992OC/DOEIIDo589
Latex Labeling Letter (Johnson)March 18, 1993OC/DOEIIDo831
Pesticide Regulation Notice 94-4: Interim Measures for the Registration of Antimicrobial Products/Liquid Chemical Germicides With Medical Device Use Claims Under the Memorandum of Understanding Between EPA and FDAJune 30, 1994OC/DOEIIDo851
Letter to Industry, Powered Wheelchair Manufacturers From RM JohnsonMay 10, 1993OC/DOEIIDo869
Hazards of Volume Ventilators and Heated HumidifiersSeptember 15, 1993OC/DOEIIDo901
Manufacturers and Initial Distributors of Sharps Containers and Destroyers Used by Health Care ProfessionalsFebruary 3, 1994OC/DOEIIDo933
Ethylene Oxide; Ethylene Chlorohydrin; and Ethylene Glycol; Proposed Maximum Residue Limits and Maximum Levels of ExposureJune 23, 1978OC/DOEIIDo1019
Letter to: Manufacturers and Users of Lasers for Refractive Surgery [Excimer]October 10, 1996OC/DOEIIDo1093
Shielded Trocars and Needles Used for Abdominal Access During LaparoscopyAugust 23, 1996OC/DOEIIDo1122
Surveillance and Detention Without Physical Examination of Condoms; Guidance for Industry; DraftAugust 14, 2000OC/DOEIIDo1139
All U.S. Condom Manufacturers, Importers and RepackagersApril 7, 1987OC/DOEIIDo2510
Start Printed Page 53884
Manufacturers and Initial Distributors of HemodialyzersMay 23, 1996OC/DOEIIDo2507
Laser Light Show Safety—Who's Responsible? (FDA 86-8262)May 1, 1986OC/DOEIIIDo13
Suggested State Regulations for Control of Radiation—Volume II Nonionizing Radiation—Lasers (FDA Pub. No. 83-8220)January 1, 1982OC/DOEIIIDo70
Letter to All Foreign Manufacturers and Importers of Electronic Products for Which Applicable FDA Performance Standards ExistMay 28, 1981OC/DOEIIIDo231
Guide for Submission of Information on Industrial X-Ray Equipment Required Pursuant to 21 CFR 1002.10March 1, 1973OC/DOEIIIDo237
Guide for Submission of Information on Analytical X-Ray Equipment Required Pursuant to 21 CFR 1002.10April 30, 1974OC/DOEIIIDo240
Guidance for the Submission of Cabinet X-Ray System Reports Pursuant to 21 CFR 1020.40February 1, 1975OC/DOEIIIDo241
Guide for Preparing Annual Reports on Radiation Safety Testing of Electronic Products (General)October 1, 1987OC/DOEIIIDo243
Computerized Devices/Processes Guidance—Application of the Medical Device GMP to Computerized Devices and Manufacturing ProcessesMay 1, 1992OC/DOEIIIDo247
Guide for Preparing Product Reports for Ultrasonic Therapy Products (Physical Therapy Only)August 1, 1996OC/DOEIIIDo249
Guide for Submission of Information on Industrial Radiofrequency Dielectric Heater and Sealer Equipment Pursuant to 21 CFR 1002.10 and 1002.12 (FDA 81-8137)September 1, 1980OC/DOEIIIDo254
Guide for Preparing Annual Reports for Ultrasonic Therapy ProductsSeptember 1, 1996OC/DOEIIIDo261
Guide for Preparing Annual Reports on Radiation Safety Testing of Sunlamps and Sunlamp Products (Replaces FDA 82-8127)September 1, 1995OC/DOEIIIDo262
Guide for Preparing Annual Reports on Radiation Safety Testing of Mercury Vapor Lamps (Replaces FDA 82-8127)September 1, 1995OC/DOEIIIDo263
Quality Control Guide for Sunlamp Products (FDA 88-8234)March 1, 1988OC/DOEIIIDo270
Guide for the Submission of Initial Reports on Computed Tomography X-Ray SystemsSeptember 1, 1984OC/DOEIIIDo271
Guide for Preparing Product Reports on Sunlamps and Sunlamp Products (21 CFR [Part] 1002)September 1, 1995OC/DOEIIIDo279
Letter: Policy on Maximum Timer Interval and Exposure Schedule for Sunlamp ProductsAugust 21, 1986OC/DOEIIIDo342
Reporting Guide for Product Reports on High Intensity Mercury Vapor Discharge Lamps (21 CFR [Part] 1002)September 1, 1995OC/DOEIIIDo348
Quality Control Practices for Compliance With the Federal Mercury Vapor Lamp Performance StandardMay 1, 1980OC/DOEIIIDo349
Start Printed Page 53885
Keeping Up With the Microwave Revolution (FDA Pub. No. 91-4160)March 1, 1990OC/DOEIIIDo356
Quality Assurance Guidelines for Hemodialysis DevicesFebruary 1, 1991OC/DOEIIIDo507
Letter to Manufacturers and Importers of Microwave Ovens—Open Door Operation of Microwave Ovens as a Result of Oven MiswiringMarch 28, 1980OC/DOEIIIDo646
Reporting of New Model Numbers to Existing Model FamiliesJune 14, 1983OC/DOEIIIDo675
Import: Radiation-Producing Electronic Products (FDA 89-8008)November 1, 1988OC/DOEIIIDo756
Unsafe Patient Lead Wires and CablesSeptember 3, 1993OC/DOEIIIDo889
Application for a Variance from 21 CFR 1040.11(c) for a Laser Light Show, Display, or Device [Form FDA 3147]July 1, 1998OC/DOEIIIDo903
Letter to Trade Association: Reuse of Single-Use or Disposable Medical DevicesDecember 27, 1995OC/DOEIIIDo961
Design Control Guidance for Medical Device ManufacturersMarch 11, 1997OC/DOEIIIDo994
Keeping Medical Devices Safe From Electromagnetic InterferenceJuly 1, 1995OC/DOEIIIDo1081
Medical Devices and EMI: The FDA PerspectiveJanuary 1, 1995OC/DOEIIIDo1082
Medical Device Electromagnetic Interference Issues, Problem Reports, Standards, and RecommendationsOC/DOEIIIDo1086
Safety of Electrically Powered Products: Letter to Medical Device and Electronic Product Manufacturers From Lillian Gill and BHB Correction MemoSeptember 18, 1996OC/DOEIIIDo1087
Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals; Guidance for Industry and for FDA StaffAugust 14, 2000OC/DOEIIIDo1168
Labeling for Electronic Anti-Theft Systems; Guidance for Industry; FinalAugust 15, 2000OC/DOEIIIDo1170
Wireless Medical Telemetry Risks and Recommendations, Guidance for Industry; FinalSeptember 27, 2000OC/DOEIIIDo1173
Policy on Warning Label Required on Sunlamp ProductsJune 25, 1985OC/DOEIIIDo1343
Policy on Lamp Compatibility (Sunlamps)September 2, 1986OC/DOEIIIDo2343
Guidance for Industry on the Likelihood of Facilities Inspections When Modifying Devices Subject to Premarket ApprovalAugust 5, 1999OC/Division of Program Operations (DPO)Do1269
Guidance on IDE Policies and Procedures [FDAMA]; FinalJanuary 20, 1998Office of Device Evaluation (ODE)Do882
Color Additives for Medical DevicesNovember 15, 1995ODEDo575
Preamendment Class III DevicesMarch 11, 1992ODEDo584
Viable Bacteriophage in CO2 Laser Plume: Aerodynamic Size DistributionDate not availableODEDo595
Guidance for Submitting Reclassification PetitionJune 1, 1989ODEDo609
Start Printed Page 53886
Electromagnetic Compatibility for Medical Devices: Issues and Solutions; MemorandumJune 13, 1995ODEDo639
SMDA Changes—Premarket Notification; Regulatory Requirements for Medical Devices [510(k)] Manual InsertApril 17, 1992ODEDo655
“Real-Time” Review Program for Premarket Approval Application (PMA) SupplementsApril 22, 1997ODEDo673
Classified Convenience KitsApril 30, 1993ODEDo789
30-Day Notices and 135-Day PMA Supplements for Manufacturing Method or Process Changes, Guidance for Industry and CDRH [FDAMA]; FinalFebruary 19, 1998ODEDo795
Suggested Content for Original IDE Application Cover Letter—Version 4February 27, 1996ODEDo797
Device Specific Guidance Documents (List)May 11, 1993ODEDo815
PMA Shell Development and Modular Review; Guidances for the Medical Device Industry; FinalNovember 6, 1998ODEDo835
Determination of Intended Use for 510(k) Devices—Guidance for Industry and CDRH Staff [FDAMA]; FinalJanuary 30, 1998ODEDo857
Premarket Notification [510(k)] Status Request Form, RevisedMarch 14, 1997ODEDo858
CDRH's 510(k)/IDE/PMA Refuse to Accept/Accept/File PoliciesJune 30, 1993ODEDo859
Indications for Use StatementFebruary 6, 1996ODEDo879
The New 510(k) Paradigm—Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications; FinalMarch 20, 1998ODEDo905
Preamendments Class III Strategy; SXAlpertApril 19, 1994ODEDo611
Letter to Industry, Powered Wheelchair/Scooter or Accessory/Component Manufacturer From Susan Alpert, Ph.D., M.D.May 26, 1994ODEDo883
ODE Executive Secretary Guidance ManualAugust 7, 1987ODEDo1338
Modifications to Devices Subject to Premarket Approval—The PMA Supplement Decision Making Process; Guidance for Industry; DraftAugust 6, 1998ODEDo102
CDRH Submissions Coversheet [PMA/PDP/510k/IDE]May 8, 1998ODEDo147
Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff [FDAMA]; FinalFebruary 19, 1998ODEDo159
Limulus Amebocyte Lysate; Reduction of Samples for TestingOctober 23, 1987ODEDo178
Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer GuidanceApril 1, 1996ODEDo198
New Section 513(f)(2)—Evaluation of Automatic Class III Designation; Guidance for Industry and CDRH Staff [FDAMA]; FinalFebruary 19, 1998ODEDo199
Start Printed Page 53887
Methods for Conducting Recall Effectiveness ChecksJune 16, 1978ODEDo225
Suggestions for Submitting a Premarket Approval (PMA) ApplicationApril 1, 1993ODEDo228
Guidance for Off-the-Shelf Software Use in Medical Devices; FinalSeptember 9, 1999ODEDo1252
Application of the Device Good Manufacturing Practice (GMP) Regulation to the Manufacture of Sterile DevicesDecember 1, 1983ODEDo267
Points to Consider in the Characterization of Cell Lines Used to Produce Biological Products (From John C. Petricciani, M.D.)June 1, 1984ODEDo269
Early Collaboration Meetings Under the FDA Modernization Act (FDAMA), Guidance for Industry and CDRH Staff [FDAMA]February 19, 1998ODEDo310
Format for IDE Progress ReportsJune 1, 1996ODEDo311
Guidance on PMA Interactive Procedures for Day-100 Meetings and Subsequent Deficiencies—For Use by CDRH and Industry [FDAMA]; FinalFebruary 19, 1998ODEDo322
Industry Representatives on Scientific PanelsMarch 27, 1987ODEDo329
PMA Review Schedule [P87-1]March 31, 1988ODEDo333
Necessary Information for Diagnostic Ultrasound 510(k) (Draft)November 24, 1987ODEDo335
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices; Guidance for FDA and Reviewers and Industry; FinalMay 29, 1998ODEDo337
Master Files Part III; Guidance on Scientific and Technical InformationJune 1, 1987ODEDo338
510(k) Quality Review Program (Blue Book Memo) (I96-1)March 29, 1996ODEDo344
FDA Policy for the Regulation of Computer Products (Draft)November 13, 1989ODEDo351
Threshold Assessment of the Impact of Requirements for Submission of PMAs for 31 Medical Devices Marketed Prior to May 28, 1976January 1, 1990ODEDo352
4-of-A-Kind PMAsOctober 1, 1991ODEDo371
Supplements to Approved Applications for Class III Medical Devices: Use Published Literature, Use of Previously Submitted Materials, and Priority Review [FDAMA]; Guidance for Industry; FinalMay 20, 1998ODEDo380
Substantial Equivalence (SE) Decision Making Documentation ATTACHED: “SE” Decision Making Process (Detailed), i.e., the Decision Making TreeJanuary 1, 1990ODEDo390
Shelf Life of Medical DevicesMarch 1, 1991ODEDo415
Guideline on General Principles of Process ValidationMay 1, 1987ODEDo425
Guideline on Sterile Drug Products Produced by Aseptic ProcessingJune 1, 1987ODEDo426
Start Printed Page 53888
Guideline on Validation of the Limulus Amebocyte Lysate (LAL) Test as an End-Product Endotoxin TestDecember 1, 1987ODEDo427
General/Specific Intended Use [FDAMA]; Draft Guidance for IndustryNovember 4, 1998ODEDo499
Distribution and Public Availability of Premarket Approval Application Summary of Safety and Effectiveness Data Packages [Blue Book Memo #P98-1]; FinalOctober 10, 1997ODEDo563
Proposal for Establishing Mechanisms for Setting Review Priorities Using Risk Assessment and Allocating Review Resources and T93-28 dated 6/25, 1993, Device “Fast Track” Plan Announcement (Include with 926-930)June 30, 1993ODEDo931
New Model Medical Device Development Process; Guidance for Industry; FinalJuly 21, 1998ODEDo1101
Guidance on the Use of Standards in Substantial Equivalence Determinations; FinalMarch 12, 2000ODEDo1131
Guidance for Industry and for FDA Reviewers; Interpretive Guidance on Section 216 of the Food and Drug Administration Modernization Act of 1997August 9, 2000ODEDo1135
Evidence Models for the Least Burdensome Means to Market; Guidance for Industry and FDA Reviewers; DraftSeptember 1, 1999ODEDo1154
Questions and Answers for the FDA Reviewer Guidance: Labeling Reusable Medical Devices for Reprocessing in Health Care FacilitiesSeptember 3, 1996ODEDo1198
Deciding When to Submit a 510(k) for a Change to an Existing Wireless Telemetry Medical Device; Final Guidance for FDA Reviewers and IndustryNovember 30, 2000ODEDo1073
Guidance on Amended Procedures for Advisory Panel MeetingsJuly 22, 2000ODEDo413
Medical Devices Containing Materials Derived From Animal Sources (Except for In Vitro Diagnostic Devices), Guidance for FDA Reviewers and Industry; FinalNovember 16, 1998ODEDo2206
Frequently Asked Questions on the New 510(k) Paradigm; Guidance for Industry; FinalOctober 22, 1998ODEDo2230
The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles; Draft Guidance for FDA and IndustryMay 3, 2001ODEDo1332
Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley CathetersSeptember 12, 1994ODE Division of Reproductive, Abdominal, and Radiological Devices (DRARD)Do97
Checklist for Mechanical Lithotripters and Stone Dislodgers Used in Gastroenterology and UrologyNovember 1, 1994ODE/DRARDDo98
Convenience Kits Interim Regulatory Guidance (Include 874)May 20, 1997ODE/510KDo562
Start Printed Page 53889
Announcement: Implementation of the FDA/HCFA Interagency Agreement Regarding Reimbursement Categorization of Investigational Devices, Att. A Interagency Agreement, Att. B Criteria for Categorization of Investigational Devices #D95-2 (Blue Book Memo)September 15, 1995ODE/BlueBookDo106
Consolidated Review of Submissions for Diagnostic Ultrasound Equipment, Accessories and Related Measurement Devices #G90-2 (Blue Book Memo)October 19, 1990ODE/BlueBookDo30
Consolidated Review of Submissions for Lasers and Accessories #G90-1 (Blue Book Memo)October 19, 1990ODE/BlueBookDo31
Review of Final Draft Medical Device Labeling #P91-4 (Blue Book Memo)August 29, 1991ODE/BlueBookDo34
Review of 510(k)s for Computer Controlled Medical Devices #K91-1 (Blue Book Memo)August 29, 1991ODE/BlueBookDo35
Use of International Standard ISO-10993, “Biological Evaluation of Medical Devices Part 1: Evaluation and Testing” (Replaces #G87-1 #8294) (Blue Book Memo)May 1, 1995ODE/BlueBookDo164
ODE Regulatory Information for the Office of Compliance—Information Sharing Procedures #G87-2 (Blue Book Memo)May 15, 1987ODE/BlueBookDo276
Panel Review of “Me-Too” Devices #P86-6 (Blue Book Memo)July 1, 1986ODE/BlueBookDo280
Guidance on the Center for Devices and Radiological Health's Premarket Notification Review Program #K86-3 (Blue Book Memo)June 30, 1986ODE/BlueBookDo289
PMA Filing Decisions #P90-2 (Blue Book Memo)May 18, 1990ODE/BlueBookDo297
PMAs—Early Review and Preparation of Summaries of Safety and Effectiveness #P86-1 (Blue Book Memo)January 27, 1986ODE/BlueBookDo302
Criteria for Panel Review of PMA Supplements #P86-3 (Blue Book Memo)January 30, 1986ODE/BlueBookDo304
Review and Approval of PMAs of Licensees #P86-4 (Blue Book Memo)October 22, 1990ODE/BlueBookDo305
Panel Report and Recommendations on PMA Approvals #P86-5 (Blue Book Memo)April 18, 1986ODE/BlueBookDo306
510(k) Sign-Off Procedures #K94-2 (Blue Book Memo)June 3, 1994ODE/BlueBookDo308
Review of Laser Submissions #G88-1 (Blue Book Memo)April 15, 1988ODE/BlueBookDo330
Delegation of IDE Actions #D88-1 (Blue Book Memo)April 26, 1988ODE/BlueBookDo331
Premarket Notification—Consistency of Reviews #K89-1 (Blue Book Memo)February 28, 1989ODE/BlueBookDo339
Telephone Communications Between ODE Staff and Manufacturers #I93-1 (Blue Book Memo)January 29, 1993ODE/BlueBookDo360
510(k) Sterility Review Guidance—and Revision of 11/18/1994 #K90-1 (Blue Book Memo)February 12, 1990ODE/BlueBookDo361
Review of IDEs for Feasibility Studies #D89-1 (Blue Book Memo)May 17, 1989ODE/BlueBookDo362
Start Printed Page 53890
Toxicology Risk Assessment Committee #G89-1 (Blue Book Memo)August 9, 1989ODE/BlueBookDo363
Assignment of Review Documents #I90-2 (Blue Book Memo)August 24, 1990ODE/BlueBookDo366
Meetings With the Regulated Industry #I89-3 (Blue Book Memo)November 20, 1989ODE/BlueBookDo367
Policy Development and Review Procedures #I90-1 (Blue Book Memo)February 15, 1990ODE/BlueBookDo368
PMA Supplements: ODE Letter to Manufacturers; Identifies Situations Which May Require the Submission of a PMA Supplement (When PMA Supplements Are Required) #P90-1 (Blue Book Memo)April 24, 1990ODE/BlueBookDo387
510(k) Refuse to Accept Procedures #K94-1 (Blue Book Memo)May 20, 1994ODE/BlueBookDo401
PMA Refuse to File Procedures #P94-1 (Blue Book Memo)May 20, 1994ODE/BlueBookDo402
Premarket Approval Application (PMA) Closure #P94-2 (Blue Book Memo)July 8, 1994ODE/BlueBookDo403
PMA/510(k) Triage Review Procedures #G94-1 (Blue Book Memo)May 20, 1994ODE/BlueBookDo404
Goals and Initiatives for the IDE Program #D95-1 (Blue Book Memo)July 12, 1995ODE/BlueBookDo405
Cover Letter: 510(k) Requirements During Firm-Initiated Recalls; Attachment A: Guidance on Recall and Premarket Notification Review Procedures During Firm-Initiated Recalls of Legally Marketed Devices (Blue Book Memo #K95-1)November 21, 1995ODE/BlueBookDo406
IDE Refuse to Accept Procedures #D94-1 (Blue Book Memo)May 20, 1994ODE/BlueBookDo410
Device Labeling Guidance #G91-1 (Blue Book Memo)March 8, 1991ODE/BlueBookDo414
Clinical Utility and Premarket Approval #P91-1 (Blue Book Memo)May 3, 1991ODE/BlueBookDo443
Panel Review of Premarket Approval Applications #P91-2 (Blue Book Memo)May 3, 1991ODE/BlueBookDo444
PMA Compliance Program #P91-3 (Blue Book Memo)May 3, 1991ODE/BlueBookDo445
Document Review Processing #I91-1 (Blue Book Memo)February 12, 1992ODE/BlueBookDo446
Integrity of Data and Information Submitted to ODE #I91-2 (Blue Book Memo)May 29, 1991ODE/BlueBookDo447
Nondisclosure of Financially Sensitive Information #I92-1 (Blue Book Memo)March 5, 1992ODE/BlueBookDo587
Memorandum of Understanding Regarding Patient Labeling Review (Blue Book Memo #G96-3))August 9, 1996ODE/BlueBookDo806
Continued Access to Investigational Devices During PMA Preparation and Review (Blue Book Memo) (D96-1)July 15, 1996ODE/BlueBookDo872
Start Printed Page 53891
510(k) Additional Information Procedures #K93-1 (Blue Book Memo)July 23, 1993ODE/BlueBookDo886
Overdue IDE Annual Progress Report Procedures #D93-1 (Blue Book Memo)July 23, 1993ODE/BlueBookDo887
Documentation and Resolution of Differences of Opinion on Product Evaluations #G93-1 (Blue Book Memo)December 23, 1993ODE/BlueBookDo920
Deciding When to Submit a 510(k) for a Change to an Exisiting Device; (Blue Book Memo #K97-1)January 10, 1997ODE/BlueBookDo1935
Interagency Agreement Between FDA and HCFA; #D95-2, Attachment ASeptember 15, 1995ODE/BlueBookDo2106
Executive Secretaries Guidance Manual #G87-3August 7, 1987ODE/BlueBookDo2326
Criteria for Categorization of Investigational Devices (HCFA); #D95-2, Attachment BSeptember 15, 1995ODE/BlueBookDo3106
Center for Devices and Radiological Health's Premarket Notification [510(k)] Refuse to Accept Policy—(Updated Checklist March 14, 1995)June 30, 1993ODE/BlueBookDo3859
HCFA Reimbursement Categorization Determinations for FDA-Approved IDEsOctober 31, 1995ODE/BlueBookDo4106
Center for Devices and Radiological Health's Investigational Device Exemption (IDE) Refuse to Accept PolicyJune 30, 1993ODE/BlueBookDo4859
Guidance for Prescription Use Drugs of Abuse Assays Premarket Notifications; Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance; Draft Guidance—Not for ImplementationNovember 14, 2000ODE Division of Clinical Laboratory Devices (DCLD)Do152
Review Criteria for Assessment of In Vitro Diagnostic Devices for Drugs of Abuse Assays Using Various MethodologiesAugust 31, 1995ODE/DCLDDo1191
Guidance for Labeling for Over-the-Counter Sample Collection Systems for Drugs of Abuse Testing; DraftDecember 21, 1999ODE/DCLDDo1359
Review Criteria for In Vitro Diagnostic Devices for the Assessment of Thyroid Autoantibodies Using Indirect Immunofluorescence Assay (IFA), Indirect Hemagglutination Assay (IHA), Radioimmunoasay (RIA), and Enzyme Linked Immunosorbent Assay (ELISA)February 1, 1994ODE/DCLDDo51
Review Criteria for Blood Culture SystemsAugust 12, 1991ODE/DCLDDo82
Points to Consider for Collection of Data in Support of In Vitro Device Submissions for 510(k) ClearanceSeptember 26, 1994ODE/DCLDDo95
Points to Consider for Portable Blood Glucose Monitoring Devices Intended for Bedside Use in the Neonate NurseryFebruary 20, 1996ODE/DCLDDo122
Criteria for Assessment of In Vitro Diagnostic Devices for Drugs of Abuse Assays Using Various Methodologies; DraftAugust 31, 1995ODE/DCLDDo1191
Review Criteria for Assessment of Rheumatoid Factor (RF) In Vitro Diagnostic Devices Using Enzyme-Linked Immunoassay (EIA), Enzyme Linked Immunosorbent Assay (ELISA), Particle Agglutination Tests, and Laser and Rate NephelometryFebruary 21, 1997ODE/DCLDDo165
Start Printed Page 53892
Assessing the Safety/Effectiveness of Home-Use In Vitro Diagnostic Devices (IVDs): Points to Consider Regarding Labeling and Premarket Submissions; DraftOctober 1, 1988ODE/DCLDDo272
Guidance for Submission of Immunohistochemistry Applications to the FDA; FinalJune 3, 1998ODE/DCLDDo364
Review Criteria for Assessment of Cytogenetic Analysis Using Automated and Semi-Automated Chromosome AnalyzersJuly 15, 1991ODE/DCLDDo417
Review Criteria for Assessment of Alpha-Fetoprotein (AFP) In Vitro Diagnostic Devices for Fetal Open Neural Tube Defects Using Immunological Test MethodologiesJuly 15, 1994ODE/DCLDDo459
Guidance for 510(k) Submission of Lymphocyte Immunophenotyping IVDs using Monoclonal Antibodies; DraftSeptember 26, 1991ODE/Do475
Points to Consider for Hematology Quality Control MaterialsSeptember 30, 1997ODE/DCLDDo512
Review Criteria for In Vitro Diagnostic Devices for Detection of IGM Antibodies to Viral AgentsAugust 1, 1992ODE/DCLDDo527
Points to Consider for Review of Calibration and Quality Control Labeling for In Vitro Diagnostic Devices/Cover Letter Dated March 14, 1996February 1, 1996ODE/DCLDDo553
Review Criteria for Devices Intended for the Detection of Hepatitis B “e” Antigen and Antibody to HBeDecember 30, 1991ODE/DCLDDo554
Guidance Criteria for Cyclosporine PMAsJanuary 24, 1992ODE/DCLDDo564
Review Criteria for Assessment of Laboratory Tests for the Detection of Antibodies to Helicobacter PyloriSeptember 17, 1992ODE/DCLDDo588
Review Criteria for Assessment of Human Chorionic Gonadotropin (hCG) In Vitro Diagnostic Devices (IVDs)September 27, 1995ODE/DCLDDo592
Premarketing Approval Review Criteria for Premarket Approval of Estrogen (ER) or Progesterone (PGR) Receptors In Vitro Diagnostic Devices Using Steroid Hormone Binding (SBA) With Dextran-Coated Charcoal (DCC) Separation, Histochemical Receptor Bi; DraftSeptember 10, 1992ODE/DCLDDo603
Review Criteria for Assessment of Portable Blood Glucose In Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase, or Hexokinase MethodologyFebruary 14, 1996ODE/DCLDDo604
Guidance for 510(k)s on Cholesterol Tests for Clinical Laboratory, Physicians' Office Laboratory, and Home UseJuly 14, 1995ODE/DCLDDo605
Review Criteria for Devices Assisting in the Diagnosis of C. Difficile Associated DiseasesMay 31, 1990ODE/DCLDDo629
Guidance Document for 510(k) Submission of Glycohemoglobin (Glycated or Glycosylated) Hemoglobin for IVDs; DraftSeptember 30, 1991ODE/DCLDDo658
Review Criteria For Premarket Approval of In Vitro Diagnostic Devices for Detection of Antibodies to Parvovirus B19May 15, 1992ODE/DCLDDo770
Start Printed Page 53893
Guidance Document for 510(k) Submission of Fecal Occult Blood Tests; DraftJuly 29, 1992ODE/DCLDDo772
Review Criteria for Assessment of In Vitro Diagnostic Devices for Direct Detection of Chlamydiae in Clinical SpecimensJanuary 1, 1992ODE/DCLDDo778
Guidance Document for 510(k) Submission of Immunoglobulins A, G, M, D and E Immunoglobulin System In Vitro Devices; DraftSeptember 1, 1992ODE/DCLDDo785
Review Criteria for the Assessment of Allergen-Specific Immunoglobulin E (IGE) In Vitro Diagnostic Devices Using Immunological Test MethodologiesMarch 2, 1993ODE/DCLDDo800
Review Criteria for the Assessment of Anti-Nuclear Antibodies (ANA) In Vitro Diagnostic Devices Using Indirect Immunofluorescence Assay (IFA), Immunodiffusion (IMD) and Enzyme Linked Immunosorbant Assay (ELISA).September 1, 1992ODE/DCLDDo848
Review Criteria for Nucleic Acid Amplification Based In Vitro Diagnostic Devices for Direct Detection of Infectious Microorganisms; DraftJune 14, 1993ODE/DCLDDo861
Review Criteria for Assessment of In Vitro Diagnostic Devices for Direct Detection of Mycobacterium Spp. [Tuberculosis (TB)]July 6, 1993ODE/DCLDDo862
Data for Commercialization of Original Equipment Manufacturer, Secondary and Generic Reagents for Automated AnalyzersJune 10, 1996ODE/DCLDDo950
Guidance Document for the Submission of Tumor Associated Antigen Premarket Notification [510(k)] to FDASeptember 19, 1996ODE/DCLDDo957
Points to Consider for Cervical Cytology DevicesJuly 25, 1994ODE/DCLDDo968
Review Criteria for In Vitro Diagnostic Devices That Utilize Cytogenetic In Situ Hybridization Technology for the Detection of Human Genetic Mutations (Germ Line and Somatic)February 15, 1996ODE/DCLDDo980
In Vitro Diagnostic Bicarbonate/Carbon Dioxide Test System; Guidance for Industry; FinalJuly 6, 1998ODE/DCLDDo1102
In Vitro Diagnostic Chloride Test System; Guidance for Industry; FinalJuly 6, 1998ODE/DCLDDo1103
In Vitro Diagnostic Creatinine Test System; Guidance for Industry; FinalJuly 2, 1998ODE/DCLDDo1104
In Vitro Diagnostic Glucose Test System; Guidance for Industry; FinalJuly 6, 1998ODE/DCLDDo1105
In Vitro Diagnostic Potassium Test System; Guidance for Industry; FinalJuly 6, 1998ODE/DCLDDo1107
In Vitro Diagnostic Sodium Test System; Guidance for Industry; FinalJuly 6, 1998ODE/DCLDDo1109
In Vitro Diagnostic Urea Nitrogen Test System; Guidance for Industry; FinalJuly 6, 1998ODE/DCLDDo1110
Guidance for Administrative Procedures for CLIA Categorization; Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance; DraftAugust 14, 2000ODE/DCLDDo1143
Start Printed Page 53894
Guidance for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Criteria for Waiver; Draft Guidance for Industry and FDA ApplicationsMarch 1, 2001ODE/DCLDDo1147
Guidance for Over-the-Counter (OTC) Ovulation Predictor 510(k)sJuly 22, 2000ODE/DCLDDo1171
Guidance for Over-the-Counter (OTC) Human Chorionic Gonadotropin (hCG) 510(k)sJuly 22, 2000ODE/DCLDDo1172
Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices; DraftMarch 8, 2000ODE/DCLDDo631
In Vitro Diagnostic C-Reactive Protein Immunological Test System; Guidance for Industry; FinalJuly 20, 1998ODE/DCLDDo1246
Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators; Guidance for Industry: FinalFebruary 22, 1999ODE/DCLDDo1247
Guidance on Labeling for Laboratory Tests; Guidance for Industry; DraftJune 24, 1999ODE/DCLDDo1352
Premarket Approval Applications for Assays Pertaining to Hepatitis C Viruses (HCV) That Are Indicated for Diagnosis or Monitoring of HCV Infection or Associated Disease; DraftOctober 8, 1999ODE/DCLDDo1353
Class II Special Control Guidance Document for Anti-Saccharomyces Cerevisiae (S. Cerevisiae) Antibody (ASCA) Premarket Notifications; FinalAugust 23, 2000ODE/DCLDDo1183
Guidance for Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final; Guidance for Industry and FDANovember 1, 2000ODE/DCLDDo1184
Review Criteria for Assessment of Antimicrobial Susceptibility Test DiscsOctober 30, 1996ODE/DCLDDo1631
Over the Counter (OTC) Screening Tests for Drugs of Abuse: Guidance for Premarket Notifications; Guidance for Industry; DraftNovember 14, 2000ODE/DCLDDo2209
Points to Consider Guidance Document on Assayed and Unassayed Quality Control Material; Guidance for IndustryFebruary 3, 1999ODE/DCLDDo2231
Document for Special Controls for Erythropoietin Assay Premarket Notifications [510(k)s]; Guidance for Industry; FinalApril 28, 1999ODE/DCLDDo2241
In Vitro Diagnostic Fibrin Monomer Paracoagulation Test; Guidance for Industry and FDA Reviewers/Staff; FinalApril 27, 1999ODE/DCLDDo2242
Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA ReviewersNovember 30, 2000ODE/DCLDDo1072
Guidance for Electrical Safety, Electromagnetic Compatibility and Mechanical Testing for Indwelling Blood Gas Analyzer Premarket Notification SubmissionsJune 28, 2000ODE Division of Cardiovascular and Respiratory Devices (DCRD)Do1161
Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions; FinalNovember 1, 2000ODE/DCRDDo372
Start Printed Page 53895
Investigational Device Exemption (IDE) Study Enrollment for Cardiac Ablation of Typical Atrial Flutter; Final Guidance for Industry and FDA ReviewersNovember 8, 2000ODE/DCRDDo1199
Guidance Document for Vascular Prostheses 510(k) Submissions; Guidance for Industry and FDA Staff; FinalNovember 1, 2000ODE/DCRDDo1357
Guidance for Annuloplasty Rings 510(k) Submissions; Final Guidance for Industry and FDA StaffJanuary 31, 2001ODE/DCRDDo1358
1-Consolidated Annual Report for a Device Product Line (1-CARD); Pilot for Preparation of Annual Reports for Pacemaker Premarket Approval ApplicationsJuly 6, 2000ODE/DCRDDo1167
Excerpts Related to EMI From November 1993 Anesthesiology and Respiratory Devices Branch (Including Electromagnetic Compatibility Standard for Medical Devices; 10/1/79)November 1, 1993ODE/DCRDDo638
Guidance for Infant/Child Apnea Monitor 510(k) SubmissionsSeptember 22, 2000ODE/DCRDDo1178
Guidance for Industry and for FDA Reviewers: Recommended Clinical Study Design for Ventricular Tachycardia AblationMay 7, 1999ODE/DCRDDo2244
Guidance for Industry: Electro-Optical Sensors for the In Vivo Detection of Cervical Cancer and its Precursors: Submission Guidance for an IDE/PMA; DraftAugust 25, 1999ODE/DCRDDo266
Guidance for Cardiovascular Intravascular Filter 510(k) Submission; FinalNovember 26, 1999ODE/DCRDDo24
Guidance for the Submission of 510(k) Premarket Notifications for Electrocardiograph (ECG) Electrode—Version 1.0February 11, 1997ODE/DCRDDo25
Guidance for the Submission of 510(k) Premarket Notifications for Electrocardiograph (ECG) Lead Switching Adapter—Version 1.0February 11, 1997ODE/DCRDDo26
Guidance Document Device: Electrocardiograph (ECG) Surface Electrode Tester—Version 1.0February 11, 1997ODE/DCRDDo27
Draft Guidance Outline—Points to Consider for Clinical Studies for Vasovasostomy DevicesNovember 30, 1993ODE/DCRDDo100
Medical Device Labeling—Suggested Format and Content; Draft DocumentApril 25, 1997ODE/DCRDDo119
Non-Invasive Blood Pressure (NIBP) Monitor GuidanceMarch 10, 1997ODE/DCRDDo123
Policy for Expiration Dating (DCRD RB92-G)October 30, 1992ODE/DCRDDo137
Human Heart Valve Allografts; DraftJune 21, 1991ODE/DCRDDo224
Guidance for Extracorporeal Blood Circuit Defoamer 510(k) Submissions; FinalFebruary 16, 2000ODE/DCRDDo1632
Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions; FinalFebruary 21, 2000ODE/DCRDDo1622
Balloon Valvuloplasty Guidance for the Submission of an IDE Application and a PMA ApplicationJanuary 1, 1989ODE/DCRDDo370
Replacement Heart Valve Guidance; DraftOctober 14, 1994ODE/DCRDDo375
Start Printed Page 53896
Implantable Pacemaker Testing GuidanceJanuary 12, 1990ODE/DCRDDo383
Letter/Guidance: Vascular Graft Manufacturer, Developer, or RepresentativeMay 11, 1990ODE/DCRDDo391
Reviewer Guidance for Ventilators; DraftJuly 1, 1995ODE/DCRDDo500
Draft 510(k) Checklist for Urological Irrigation System and Tubing SetAugust 1, 1995ODE/DCRDDo515
Draft Guidance to Firms on Biliary Lithotripsy StudiesAugust 2, 1990ODE/DCRDDo522
Draft Guidance for Clinical Investigations of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH)November 11, 1994ODE/DCRDDo533
Letter: Notice to Manufacturers of Bone Mineral DensitometersSeptember 25, 1997ODE/DCRDDo552
Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers: DraftSeptember 30, 1997ODE/DCRDDo560
Draft Guidance for the Content of Premarket Notifications for Urological Balloon Dilatation CathetersJanuary 24, 1992ODE/DCRDDo567
Guideline for the Arrangement and Content of a Premarket Approval (PMA) Application for a Cochlear Implant in Adults at Least 18 Years of AgeMay 1, 1990ODE/DCRDDo577
Guidance for the Preparation of the Annual Report to the PMA Approved Heart Valve ProsthesesApril 1, 1990ODE/DCRDDo582
Draft Version: Electrode Recording Catheter Preliminary Guidance (Data to Be Sumitted to the FDA in Support of Premarket Notifications [510(k)s])March 1, 1995ODE/DCRDDo602
Cardiac Ablation Preliminary Guidance (Data to Be Submitted to the FDA in Support Investigation Device Exemption Application; DraftMarch 1, 1995ODE/DCRDDo619
Premarket Testing Guidelines for FalloposcopesNovember 20, 1992ODE/DCRDDo621
Guidelines for Evaluation of Non-Drug IUDsSeptember 28, 1976ODE/DCRDDo641
Simplified 510(k) procedures for certain radiology devices: 12/21, 1993, letter from L Yin, ODE/ODE/DRARD, to NEMADecember 21, 1993ODE/DCRDDo708
Draft 510(k) Checklist for Endoscopic Electrosurgical Unit (ESU) and Accessories Used in Gastroenterology and UrologyAugust 16, 1995ODE/DCRDDo768
Heated Humidifier Review GuidanceAugust 30, 1991ODE/DCRDDo780
Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and ActuatorsOctober 1, 1993ODE/DCRDDo784
Reviewer Guidance for Automatic X-Ray Film Processor 510(k)February 1, 1990ODE/DCRDDo788
Guidance for the Technical Content of a Premarket Approval (PMA) Application for an Endolymphatic Shunt Tube With ValveApril 1, 1990ODE/DCRDDo791
Guidance for Magnetic Resonance Diagnostic Devices—Criteria for Significant Risk InvestigationsSeptember 29, 1997ODE/DCRDDo793
Start Printed Page 53897
Draft Guidance for Preparation of PMA Applications for Testicular ProsthesesMarch 16, 1993ODE/DCRDDo809
Draft Guidance for Preparation of PMA Applications for Penile Inflatable ImplantsMarch 16, 1993ODE/DCRDDo810
Draft Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for HemodialysisMay 30, 1997ODE/DCRDDo842
Guidance for the Submission of Research and Marketing Applications for Interventional Cardiology Devices: PTCA Catheters, Atherectomy Catheters, Lasers, Intravascular Stents; DraftMay 1, 1995ODE/DCRDDo846
Draft Guidance for Preclinical and Clinical Investigations of Urethral Bulking Agents Used in the Treatment of Urinary IncontinenceNovember 29, 1995ODE/DCRDDo850
Draft Guidance for Review of Bone Densitometer 510(k) SubmissionsNovember 9, 1992ODE/DCRDDo866
Battery GuidanceJuly 12, 1993ODE/DCRDDo873
Guidance for the Preparation of Research and Marketing Applications for Vascular Graft Prostheses; DraftAugust 1, 1993ODE/DCRDDo885
510(k) Checklist for Sterile Lubricating Jelly Used With Transurethral Surgical InstrumentsSeptember 19, 1994ODE/DCRDDo892
Draft Guidance for Hemodialyzer Reuse LabelingOctober 6, 1995ODE/DCRDDo899
Hysteroscopes and Gynecology Laparoscopes—Submission Guidance for a 510(k)—Includes 00192March 27, 1996ODE/DCRDDo907
Draft Guidance for the Content of Premarket Notifications for Loop and Rollerball Electrodes for GYN Electrosurgical ExcisionsJuly 29, 1991ODE/DCRDDo953
Intravascular Brachytherapy—Guidance for Data to be Submitted to the Food and Drug Administration in Support of Investigational Device Exemption (IDE) Applications; DraftMay 24, 1996ODE/DCRDDo955
Percutaneous Transluminal Coronary Angioplasty Package Insert Template; DraftFebruary 7, 1995ODE/DCRDDo959
Coronary and Cerebrovascular Guidewire GuidanceJanuary 1, 1995ODE/DCRDDo964
Guidance for Implantable Cardioverter-Defibrillators; DraftJune 24, 1996ODE/DCRDDo965
Carotid Stent—Suggestions for Content of Submissions to the Food and Drug Administration in Support of Investigational Devices Exemption (IDE) ApplicationsOctober 26, 1996ODE/DCRDDo974
Emergency Resuscitator Guidance; DraftApril 14, 1993ODE/DCRDDo985
Review Guidelines for Oxygen Generators and Oxygen Equipment; Draft DocumentApril 14, 1993ODE/DCRDDo986
Draft 510(k) Checklist for Condom CathetersFebruary 23, 1995ODE/DCRDDo991
CDRH Interim Regulatory Policy for External Penile Rigidity DevicesSeptember 10, 1997ODE/DCRDDo992
Start Printed Page 53898
Reviewer Guidance on Face Masks and Shield for CPR; DraftMarch 16, 1994ODE/DCRDDo996
General Guidance Document: Non-Invasive Pulse OximeterSeptember 7, 1992ODE/DCRDDo997
Guidance for Peak Flow Meters for Over-the-Counter SaleJune 23, 1992ODE/DCRDDo998
510(K) Submission Requirements for Peak Flow Meters; DraftJanuary 13, 1994ODE/DCRDDo999
Guidance for Industry and FDA; Guidance for Indwelling Blood Gas Analyzer 510(k) SubmissionsFebruary 21, 2000ODE/DCRDDo1126
Guidance Document for Premarket Notification Submission for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer; FinalJanuary 24, 2000ODE/DCRDDo1157
Latex Condoms for Men—Information for 510(k) Premarket Notifications: Use of Consensus Standards for Abbreviated SubmissionsJuly 23, 1998ODE/DCRDDo1250
Guidance for Industry—Uniform Contraceptive Labeling; FinalJuly 23, 1998ODE/DCRDDo1251
Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions; FinalJanuary 17, 2000ODE/DCRDDo1361
Guidance for the Content of Premarket Notifications for Penile Rigidity Implants; FinalJanuary 16, 2000ODE/DCRDDo177
Federal Register Notice; Devices Used for In Vitro Fertilization and Related Assisted Reproduction Procedures: Submission Guidance for a 510(k); Draft; AvailabilitySeptember 10, 1998ODE/DCRDDo1620
Hysteroscopic and Laparoscopic Insufflators: Submission Guidance for a 510(k)August 1, 1995ODE/DCRDDo1907
Guidance for Industry and CDRH Reviewers—Guidance for the Content of Premarket Notifications for Hemodialysis Delivery Systems; FinalAugust 7, 1998ODE/DCRDDo2202
Noise Claims in Hearing Aid Labeling; FinalOctober 21, 1998ODE/DCRDDo2210
Guidance for Industry—Diagnostic ECG Guidance (Including Non-Alarming ST Segment Measurement); FinalNovember 5, 1998ODE/DCRDDo2232
Guidance for Industry—Cardiac Monitor Guidance (including Cardiotachometer and Rate Alarm); FinalNovember 5, 1998ODE/DCRDDo2233
Guidance for Industry—Harmonic Imaging With/Without Contrast—Premarket Notification; FinalNovember 16, 1998ODE/DCRDDo2234
Guidance for Industry—Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters; FinalNovember 30, 1998ODE/DCRDDo2235
Guidance for Industry—Guidance for the Submission of Premarket Notifications for Radionuclide Dose Calibrators; FinalNovember 20, 1998ODE/DCRDDo2238
Guidance for Industry—Non-Automated Sphygmomanometer (Blood Pressure Cuff) Guidance; Version 1; FinalNovember 19, 1998ODE/DCRDDo2239
Start Printed Page 53899
Guidance for Industry—Guidance for the Submission of Premarket Notifications for Emission Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems; FinalDecember 3, 1998ODE/DCRDDo2240
Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents; FinalFebruary 5, 1998ODE/DCRDDo2243
Guidance for the Submission of 510(k)'s for Solid State X-Ray Imaging Devices; FinalAugust 6, 1999ODE/DCRDDo644
Class II Special Control Guidance Document for Acute Upper Airway Obstruction DevicesJuly 30, 2000ODE/DCRDDo1138
Guidance for Conducting Stability Testing to Support an Expiration Date Labeling Claim for Medical Gloves; DraftNovember 16, 1999ODE Division of Dental, Infection Control and General Hospital Devices (DDIGD)Do1355
Reprocessing and Reuse of Single-Use Devices: Review Prioritization Scheme; DraftFebruary 8, 2000ODE/DDIGDDo1156
Premarket Approval Applications (PMA) for Sharps Needle Destruction Devices; Final Guidance for Industry and FDAMarch 2, 2001ODE/DDIGDDo891
Guidance on the Content and Format of Premarket Notification 510(k) Submissions of Washers and Washer-DisinfectorsJune 2, 1998ODE/DDIGDDo4
Overview of Information Necessary for Premarket Notification Submissions for Endosseous Implants; FinalApril 21, 1999ODE/DDIGDDo86
Guidance for the Arrangement and Content of a Premarket Approval (PMA) Application for an Endosseous Implant for Prosthetic AttachmentMay 16, 1989ODE/DDIGDDo353
Guidance on 510(k) Submissions for Implanted Infusion PortsOctober 1, 1990ODE/DDIGDDo392
Guidance on the Content of Premarket Notification [510(K)] Submissions for Hypodermic Single Lumen NeedlesApril 1, 1993ODE/DDIGDDo450
Guidance Document on Dental HandpiecesJuly 1, 1995ODE/DDIGDDo556
Guidance on the Content and Format of Premarket Notification 510(k) Submissions for Liquid Chemical GermicidesDecember 6, 1996ODE/DDIGDDo576
Guidance on the Content of Premarket Notification [510(K)] Submissions for Piston SyringesApril 1, 1993ODE/DDIGDDo821
Guidance on the Content of Premarket Notification [510(K)] Submissions for Clinical Electronic ThermometersMarch 1, 1993ODE/DDIGDDo822
Guidance on the Content of Premarket Notification [510(k)] Submissions for External Infusion PumpsMarch 1, 1993ODE/DDIGDDo823
Guidance on Premarket Notification [510(K)] Submissions for Short-Term and Long-Term Intravascular CathetersMarch 16, 1995ODE/DDIGDDo824
Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care FacilitiesMarch 1, 1993ODE/DDIGDDo833
Start Printed Page 53900
Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care FacilitiesAugust 1, 1993ODE/DDIGDDo881
Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical DrapesAugust 1, 1993ODE/DDIGDDo888
Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Sharps ContainersOctober 1, 1993ODE/DDIGDDo895
Draft Supplementary Guidance on the Content of Premarket Notification [510(k)] Submissions for Medical Devices With Sharps Injury Prevention Features (Antistick)March 1, 1995ODE/DDIGDDo934
Guidance for Industry and FDA Reviewers/Staff—Premarket Notification [510(k)] Submissions for Testing for Skin Sensitization to Chemicals in Natural Latex Products [Draize Testing]January 13, 1999ODE/DDIGDDo944
Information Necessary for Premarket Notification Submissions for Screw-Type Endossesous ImplantsDecember 9, 1996ODE/DDIGDDo948
Draft Guidance Document for the Preparation of Premarket Notification [510(k)'s] for Dental AlloysMarch 3, 1997ODE/DDIGDDo984
Guidance on the Content of Premarket Notification [510(k)] Submissions for Protective RestraintsDecember 1, 1995ODE/DDIGDDo993
Guidance on Premarket Notifications for Intravascular Administration Sets; Guidance for Industry and FDA Review Staff; FinalOctober 12, 2000ODE/DDIGDDo1189
Addendum to: Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care FacilitiesSeptember 19, 1995ODE/DDIGDDo1833
Groups Capable of Testing for Latex Skin Sensitization (Addendum to #944)July 28, 1997ODE/DDIGDDo1944
Guidance for Industry and FDA Reviewers; Neonatal and Neonatal Transport Incubators—Premarket Notifications; FinalSeptember 18, 1998ODE/DDIGDDo2201
Dental Impression Materials—Premarket Notification; FinalAugust 17, 1998ODE/DDIGDDo2203
Dental Cements Premarket Notification; FinalAugust 18, 1998ODE/DDIGDDo2204
OTC Denture Cushions, Pads, Reliners, Repair Kits and Partially Fabricated Denture Kits; FinalAugust 18, 1998ODE/DDIGDDo2205
Guidance for the Preparation of a Premarket Notification [510(k)] for Direct Filling Dental CompositesNovember 27, 1998ODE/DDIGDDo642
Guidance and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants; FinalJanuary 3, 2000ODE/DDIGDDo397
Class II Special Control Guidance Document: Pharmacy Compounding Devices; Final Guidance for Industry and FDAMarch 12, 2001ODE/DDIGDDo1326
Guidance for Industry: Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses; FinalApril 28, 1998ODE Division of General, Restorative and Neurological Devices (DGRND)Do6
Start Printed Page 53901
Calcium Phosphate (Ca-P) Coating Draft Guidance for Preparation of FDA Submissions for Orthopedic and Dental Endosseous ImplantsFebruary 21, 1997ODE/DGRNDDo33
510(k) Information Needed for Hydroxyapatite Coated Orthopedic ImplantsFebruary 20, 1997ODE/DGRNDDo47
Letter: Core Study for Silicone Breast ImplantsJanuary 11, 1996ODE/DGRNDDo107
Protocol for Dermal Toxicity Testing for Devices in Contact With Skin (Draft)January 1, 1985ODE/DGRNDDo124
Draft Version 1—Biofeedback Devices—Draft Guidance for 510(k) ContentAugust 1, 1994ODE/DGRNDDo143
Draft Data Requirements for Ultrahigh Molecular Weight Polyethylene (Uhmupe) Used in Orthopedic DevicesMarch 28, 1995ODE/DGRNDDo180
Draft Guidance Document for Femoral Stem ProsthesesAugust 1, 1995ODE/DGRNDDo187
Draft Premarket Notification Review Guidance for Evoked Response Somatosensory StimulatorsJune 1, 1994ODE/DGRNDDo207
Draft Version Guide for Cortical Electrode 510(k) ContentAugust 10, 1992ODE/DGRNDDo208
Draft Version Guidance for Clinical Data to be Submitted for Premarket Approval Application for Cranial Electrotherapy StimulatorsAugust 20, 1992ODE/DGRNDDo209
Draft Version Cranial Perforator GuidanceJuly 13, 1994ODE/DGRNDDo212
Draft Version Neuro Endoscope GuidanceJuly 7, 1994ODE/DGRNDDo214
Galvanic Skin Response Measurement Devices—Draft Guidance for 510(k) ContentAugust 1, 1994ODE/DGRNDDo215
Guidance Document for the Preparation of IDE and PMA Applications for Intra-Articular Prosthetic Knee Ligament DevicesFebruary 18, 1993ODE/DGRNDDo233
Guidance for Industry, FDA Reviewers/Staff and Compliance Guidance Document for Powered Muscle Stimulator 510(k)s; FinalJune 9, 1999ODE/DGRNDDo2246
Guidance for Industry—Guidance for the Preparation of a Premarket Notification Application for Processed Human Dura Mater; FinalAugust 30, 1999ODE/DGRNDDo54
Guide for TENS 510(k) Content (Draft)August 1, 1994ODE/DGRNDDo300
Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Submerged (Underwater) Exercise EquipmentJuly 26, 1995ODE/DGRNDDo307
Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Electromyograph Needle ElectrodesJuly 26, 1995ODE/DGRNDDo325
Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Exercise EquipmentJuly 26, 1995ODE/DGRNDDo326
Guidance Document for the Preparation of Premarket Notification [510k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled VehiclesJuly 26, 1995ODE/DGRNDDo346
Start Printed Page 53902
Guidance Document for the Preparation of Premarket Notification for Ceramic Ball Hip SystemsJanuary 10, 1995ODE/DGRNDDo355
Guidance on the Content and Organization of a Premarket Notification for a Medical LaserJune 1, 1995ODE/DGRNDDo386
Draft Guidance Document for Testing Acetabular Cup ProsthesesMay 1, 1995ODE/DGRNDDo453
Guidance Document for Industry and CDRH Staff for the Preparation of Investigational Device Exemptions and Premarket Approval Applications for Bone Growth Stimulator Devices; DraftMarch 18, 1998ODE/DGRNDDo487
Copy of October 9, 1992, Letter and Original Suture Labeling Guidance (Reformatted 12/17/1997)October 9, 1992ODE/DGRNDDo502
Alternate Suture Labeling Resulting From the January 11, 1993, Meeting With HIMA (Reformatted 12/17/1997)January 11, 1993ODE/DGRNDDo503
Guidelines for Reviewing Premarket Notifications that Claim Substantial Equivalence to Evoked Response StimulatorsFebruary 1, 1997ODE/DGRNDDo593
Draft Version—Guidance on Biocompatibility Requirements for Long Term Neurological Implants: Part 3—Implant ModelSeptember 12, 1994ODE/DGRNDDo627
Guidance for Studies for Pain Therapy Devices—General Considerations in the Design of Clinical Studies for Pain-Alleviating DevicesMay 12, 1988ODE/DGRNDDo640
ORDB 510(k) Sterility Review GuidanceJuly 3, 1997ODE/DGRNDDo659
Draft Guidance for the Preparation of a Premarket Notification for Extended Laparoscopy Devices (ELD)August 30, 1994ODE/DGRNDDo667
Draft Outline for a Guidance Document for Testing Orthopedic Bone Cement, Request for Comments by December 10, 1993November 1, 1993ODE/DGRNDDo668
Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for BedsJuly 26, 1995ODE/DGRNDDo689
Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Immersion HydrobathsJuly 26, 1995ODE/DGRNDDo729
Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Powered Tables and Multifunctional Physical Therapy TablesJuly 26, 1995ODE/DGRNDDo735
Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Communications Systems (Powered and Non-Powered) and Powered Environmental Control SystemsJuly 26, 1995ODE/DGRNDDo762
Electroencephalograph Devices Guidance for 510(k) Content; DraftNovember 3, 1997ODE/DGRNDDo767
Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Therapeutic Massagers and VibratorsJuly 26, 1995ODE/DGRNDDo818
Guidance Document for Testing Orthopedic Implants With Modified Metallic Surfaces Apposing Bone or Bone Cement (Replaces 8623 and 8093)April 28, 1994ODE/DGRNDDo827
Start Printed Page 53903
Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and Cooling DevicesJuly 26, 1995ODE/DGRNDDo828
Reviewers Guidance Checklist for Orthopedic External Fixation DevicesFebruary 21, 1997ODE/DGRNDDo829
Draft Guidance for the Preparation of Premarket Notifications [510(k)]s for Cemented, Semi-Constrained Total Knee ProsthesesApril 1, 1993ODE/DGRNDDo830
Draft Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Orthopedic Devices—The Basic ElementsJuly 16, 1997ODE/DGRNDDo832
Draft 510(k) Guideline for General Surgical Electrosurgical DevicesMay 10, 1995ODE/DGRNDDo904
Draft Guidance for Arthroscopes and Accessory 510(k)sMay 1, 1994ODE/DGRNDDo909
Guidance Document for Testing Biodegradable Polymer Implant Devices; DraftApril 20, 1996ODE/DGRNDDo914
Guidance Document for Testing Bone Anchor Devices; DraftApril 20, 1996ODE/DGRNDDo915
Guidance Document for Testing Non-Articulating, “Mechanically Locked”, Modular Implant Components; DraftMay 1, 1995ODE/DGRNDDo916
Reviewers Guidance Checklist for Intramedullary RodsFebruary 21, 1997ODE/DGRNDDo956
Draft Guidance for Testing MR Interaction With Aneurysm ClipsMay 22, 1996ODE/DGRNDDo958
Guidance for Industry—Guidance Document for Dura Substitute Devices; FinalAugust 13, 1999ODE/DGRNDDo1152
Guidance Document for Surgical Lamp 510Ks; FinalJuly 13, 1998ODE/DGRNDDo1244
Guidance for Industry—Guidance on Preclinical and Clinical Data and Labeling for Breast Prostheses; DraftOctober 5, 1999ODE/DGRNDDo1354
Guidance Document for the Preparation of IDEs for Spinal Systems; FinalJanuary 13, 2000ODE/DGRNDDo2250
Draft Guidance for the Preparation of an IDE Submission for a Interactive Wound and Burn DressingApril 4, 1995ODE/DGRNDDo1817
Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance—Guidance Document for Powered Suction Pump 510(k)sOctober 30, 1998ODE/DGRNDDo2207
Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh; FinalMarch 2, 1999ODE/DGRNDDo2247
Class II Special Controls Guidance Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis; FinalOctober 31, 2000ODE/DGRNDDo1193
Guidance for Dermabrasion Devices; FinalMarch 2, 1999ODE/DGRNDDo2248
Draft Guidance for the Preparation of a Premarket Notification for a Non-Interactive Wound and Burn Dressing [510(k)]May 31, 1995ODE/DGRNDDo2817
Start Printed Page 53904
Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery; DraftDecember 16, 1999ODE/DGRNDDo1356
Special Control Guidance for Premarket Notifications for Totally Implanted Spinal Cord Stimulators for Pain Relief; Guidance for Industry; DraftSeptember 6, 2000ODE/DGRNDDo1179
Guidance for Surgical Suture 510(k)s; Guidance for Industry; FinalAugust 10, 2000ODE/DGRNDDo1180
Guidance for Neurological Embolization Devices; Guidance for Industry; FinalNovember 1, 2000ODE/DGRNDDo1151
Guidance for Spinal System 510(k)sSeptember 27, 2000ODE/DGRNDDo636
FDA Guidelines for Multifocal Intraocular Lens IDE Studies and PMAsMay 29, 1997ODE Division of Ophthalmic and Ear, Nose, and Throat Devices (DOED)Do55
Announcement: Information for Manufacturers and Users of Lasers for Refractive Surgery [Excimer]September 22, 1997ODE/DOEDDo93
Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Surgical Mask—DraftJanuary 16, 1998ODE/DOEDDo94
New FDA Recommendations and Results of Contact Lens Study (7-Day Letter)May 30, 1989ODE/DOEDDo265
Draft Premarket Notification 510(k) Guidance for Contact Lens Care ProductsMay 1, 1997ODE/DOEDDo674
Important Information About Rophae Intraocular LensesAugust 20, 1992ODE/DOEDDo811
Draft Premarket Notification [510(k)] Guidance Document for Class II Daily Wear Contact Lenses and 6/28, 1994, Corrections to Pages 18 and 20May 12, 1994ODE/DOEDDo896
Retinoscope Guidance; FinalJuly 8, 1998ODE/DOEDDo1240
Guidance for Industry—Ophthalmoscope Guidance (Direct and Indirect)July 8, 1998ODE/DOEDDo1241
Slit Lamp Guidance; FinalJuly 13, 1998ODE/DOEDDo1242
Guidance for Industry and FDA Staff—Revised Procedures for Adding Lens Finishing Laboratories to Approved Premarket Approval (PMA) Applications for Class III Rigid Gas Permeable Contact Lenses for Extended Wear; FinalAugust 11, 1998ODE/DOEDDo1249
Accountability Analysis for Clinical Studies for Ophthalmic Devices; DraftAugust 4, 1999ODE/DOEDDo1350
Guidance on 510(k) Submissions for Keratoprostheses; FinalMarch 3, 1999ODE/DOEDDo1351
Amendment 1: Draft Premarket Notification [510(k)] Guidance Document for Class II Daily Wear Contact LensesJune 28, 1994ODE/DOEDDo1896
Checklist of Information Usually Submitted in an Investigational Device Exemptions (IDE) Application for Refractive Surgery Lasers [Excimer]October 10, 1996ODE/DOEDDo2093
Third Party Review Guidance for Vitreous Aspiration and Cutting Device Premarket Notification [510(k)]January 31, 1997ODE/DOEDDo2196
Start Printed Page 53905
Guidance Document for Nonprescription Sunglasses; FinalOctober 9, 1998ODE/DOEDDo2208
Aqueous Shunts—510(k) Submissions; FinalNovember 16, 1998ODE/DOEDDo2236
Discussion Points for Expansion of the “Checklist of Information Usually Submitted in an Investigational Device Exemption (IDE) Application for Refractive Surgery Lasers” Draft DocumentSeptember 5, 1997ODE/DOEDDo7093
Intraocular Lens (IOL) Guidance Document; DraftOctober 14, 1999ODE/DOEDDo834
Refractive Implants: Guidance for Investigational Device Exemptions (IDE) and Premarket Approval (PMA) ApplicationsAugust 1, 2000ODE/DOEDDo1145
Guidance on Premarket Submissions of Orthokeratology Rigid Gas Permeable Contact Lenses; FinalApril 10, 2000ODE/DOEDDo1134
Guidance for Manufacturers Seeking Marketing Clearance of Ear, Nose, and Throat Endoscope Sheaths Used as Protective Barriers; FinalMarch 12, 2000ODE/DOEDDo954
Information for a Latex Condom 510(k) Submission for Obstetrics-Gynecology Devices Branch—DraftApril 13, 1994ODE Division of Reproductive, Abdominal, and Radiological Devices (DRARD)Do398
Guidance for the Content of Premarket Notifications for Urine Drainage BagsJune 7, 1994ODE/DRARDDo96
Draft—510(k) Checklist for Conditioned Response Enuresis AlarmsNovember 23, 1994ODE/DRARDDo99
Draft Guidance for Preparation of PMA Applications for the Implanted Mechanical/Hydraulic Urinary Continence Device (Artificial Urinary Sphincter)May 1, 1995ODE/DRARDDo161
Draft Guidance for the Content of Premarket Notifications for Endoscopes Used in Gastroenterology and UrologyMarch 17, 1995ODE/DRARDDo162
Draft Guidance for the Content of Premarket Notifications for Menstrual TamponsMay 25, 1995ODE/DRARDDo166
Draft 510(k) Checklist for Non-Implanted Electrical Stimulators Used for the Treatment of Urinary IncontinenceJune 6, 1995ODE/DRARDDo189
Draft 510(k) Checklist for Endoscopic Light Sources Used in Gastroenterology and UrologyJune 22, 1995ODE/DRARDDo190
Guidance (“Guidelines”) for Evaluation of Laparoscopic Bipolar and Thermal Coagulators (and Accessories)May 1, 1978ODE/DRARDDo232
Guidance (“Guidelines”) for Evaluation of Fetal Clip ElectrodeMarch 8, 1977ODE/DRARDDo244
Guidance (“Guidelines”) for Evaluation of Tubal Occlusion DevicesNovember 22, 1977ODE/DRARDDo245
Guidance (“Guidelines”) for Evaluation of Hysteroscopic Sterilization DevicesMay 10, 1978ODE/DRARDDo248
Intrapartum Continuous Monitors for Fetal Oxygen Saturation and Fetal pH; Submission Guidance for a PMA; Draft DocumentJune 14, 1997ODE/DRARDDo298
Start Printed Page 53906
Guidance for the Arrangement and Content of a Premarket Approval (PMA) Application For A Cochlear Implant in Children Ages 2 Through to 17 YearsMay 1, 1990ODE/DRARDDo327
Guidance for Industry—Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices; FinalNovember 14, 1998ODE/DRARDDo340
Premarket Testing Guidelines for Female Barrier Contraceptive Devices Also Intended to Prevent Sexually Transmitted DiseasesApril 4, 1990ODE/DRARDDo384
Draft of Suggested Information for Reporting Extracorporeal Shock Wave Lithotripsy Device Shock Wave MeasurementsJanuary 18, 1991ODE/DRARDDo418
Guidance for the Content of Premarket Notifications for Conventional and Permeability Hemodialyzers; FinalAugust 7, 1998ODE/DRARDDo421
Guidance for the Content of Premarket Notifications for Urethral StentsFebruary 10, 1993ODE/DRARDDo431
Testing Guidance for Male Condoms Made From New Material (Non-Latex)June 29, 1995ODE/DRARDDo455
Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and UrologyFebruary 10, 1993ODE/DRARDDo482
Guidance for the Content of Premarket Notifications for Urodynamic/Uroflowmetry SystemsJuly 29, 1994ODE/DRARDDo490
Guidance for Investigational Device Exemptions for Solutions for Hypothermic Flushing, Transport, and Storage of Organs for Transplantation; Final Guidance for Industry and FDA ReviewersJanuary 16, 2001ODE/DRARDDo1164
Guidance for the Submission of Premarket Notifications for Medical Image Management Devices; Guidance for Industry; FinalJuly 27, 2000ODE/DRARDDo416
Guidance for the Content of Premarket Notifications (510(k)s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi; FinalAugust 9, 2000ODE/DRARDDo1226
Guidance for the Submission of Premarket Notifications for Photon-Emitting Brachytherapy Sources; Guidance for Industry; FinalAugust 2, 2000ODE/DRARDDo1177
Premarket Applications for Digital Mammography Systems; Final Guidance for Industry and FDAFebruary 16, 2001ODE/DRARDDo983
Class II Special Controls Guidance for Home Uterine Activity Monitors; Final Guidance for Industry and FDA ReviewersMarch 9, 2001ODE/DRARDDo820
Class II Special Controls Guidance Document for Clitoral Engorgement Devices; Guidance for Industry and FDA ReviewersJuly 3, 2000ODE/DRARDDo1144
Thermal Endometrial Ablation Devices (Submission Guidance for an IDE); FinalMarch 14, 1996ODE/DRARDDo547
Draft Guidance for the Clinical Investigation of Urethral StentsNovember 2, 1995ODE/DRARDDo573
Start Printed Page 53907
Tympanostomy Tubes Submission Guidance for a 510(k) Premarket Notification; FinalJanuary 14, 1998ODE/DRARDDo930
Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Final Guidance for Industry and for CDRH StaffFebruary 28, 2001ODE Program Operations Staff (POS)Do310
PMA/510(k) Expedited Review #G98-4 (Blue Book Memo)March 20, 1998ODE/POSDo7
PMA/510(k) Expedited Review—Guidance for Industry and CDRH Staff [FDAMA]; FinalMarch 20, 1998ODE/POSDo108
Deciding When to Submit a 510(k) for a Change to an Existing DeviceJanuary 10, 1997ODE/POSDo935
A Suggested Approach to Resolving Least Burdensome IssuesSeptember 11, 2000ODE/POSDo1188
Suggested Format for Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions of FDAMA; Final; Guidance for Industry and FDA StaffNovember 2, 2000ODE/POSDo1195
FDA Modernization Act of 1997 Guidance for the Device Industry on Implementation of Highest Priority Provisions [FDAMA]February 6, 1998Office of Health and Industry Programs (OHIP)Do434
Accidental Radioactive Contamination of Human Food and Animal Feeds: Recommendations to State and Local AgenciesAugust 13, 1998OHIPDo1071
Compliance Guidance—The Mammography Quality Standards Act Final Regulations—Preparing for MQSA InspectionsMay 5, 1999OHIP Division of Mammography Quality and Radiation Programs (DMQRP)Do6400
Guidance for Submission of Request for Reconsideration of Adverse Decisions on Accreditation of Mammography Facilities Under the Mammography Quality Standards Acts, 42 U.S.C. 263(b)/4/8, 1998March 26, 1998OHIP/DMQRPDo69
Guidance for Review of Requests for Reconsideration of Adverse Decisions on Accreditation of Mammography Facilities Under the Mammography Quality Standards Act, 42 U.S.C. 263(b)/4/8, 1998March 26, 1998OHIP/DMQRPDo83
Compliance Guidance; The Mammography Quality Standards Act Final Regulations Document #4; DraftSeptember 13, 2000OHIP/DMQRPDo1159
The Mammography Quality Standards Act Final Regulations; Modifications and Additions to Policy Guidance Help System #2; Final Guidance for Industry and FDA (Incorporated into PGHS)January 24, 2001OHIP/DMQRPDo1317
Compliance Guidance: The Mammography Quality Standards Act Final Regulations Document #3 (Incorporated into PGHS)December 8, 1999OHIP/DMQRPDo1496
Guidance: The Mammography Quality Standards Act Final Regulations Document #1 (Incorporated into PGHS)March 4, 1999OHIP/DMQRPDo1499
Policy and Standard Operating Procedures When Mammography Facilities in States That Have Accreditation Bodies Intend to Change Accreditation BodiesApril 15, 1998OHIP/DMQRPDo1186
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Guidance for Request and Issuance of Interim Notice Letters for Mammography Facilities Under the Mammography Quality Standards Act, 42 U.S.C. Section 263(b)May 4, 1999OHIP/DMQRPDo2217
Continuing Education Credit for Reading/Writing Articles/Papers and Presenting Courses/Lectures (Incorporated into PGHS)March 17, 1998OHIP/DMQRPDo66206
Guidance for Industry—Requalification for Interpreting Physician's Continuing Experience Requirement (Incorporated into PGHS)May 28, 1998OHIP/DMQRPDo66301
Compliance Guidance: The Mammography Quality Standards Act Final Regulations Motion of Tube-Image Receptor Assembly (Incorporated into PGHS)March 23, 1999OHIP/DMQRPDo2256
Compliance Guidance: The Mammography Quality Standards Act Final Regulations Quality Assurance Documentation (Incorporated into PGHS)December 7, 1999OHIP/DMQRPDo1194
Compliance Guidance: The Mammography Quality Standards Act Final Regulations Document #2 (Incorporated into PGHS)February 25, 2000OHIP/DMQRPDo1498
Compliance Guidance—Mammography Facility Survey, Equipment Evaluation and Medical Physicist Qualification Requirements Under MQSA; FinalNovember 6, 2000OHIP/DMQRPDo6409
Medical Glove Guidance Manual Draft FDA 99-4257August 12, 1999OHIP Division of Small Manufacturers Assistance (DSMA)Do852
Instructions for Completion of Medical Device Registration and Listing Forms FDA 2891, 2891a and 2892July 1, 1997OHIP/DSMADo12
An Introduction to Medical Device Regulations (FDA 92-4222)January 1, 1992OHIP/DSMADo18
Regulatory Requirements for Devices for the Handicapped (FDA 87-4221)August 1, 1987OHIP/DSMADo22
Impact Resistant Lenses: Questions and Answers (FDA 87-4002)September 1, 1987OHIP/DSMADo23
Comparison Chart: 1996 Quality System Reg vs. 1978 Good Manufacturing Practices Reg vs. ANSI/ISO/ASQC Q9001 and ISO/DI 13485:1996 (Include 126)November 29, 1996OHIP/DSMADo133
Medical Device Appeals and Complaints: A Guidance on Dispute ResolutionFebruary 19, 1998OHIP/DSMADo396
Premarket Notification: 510(k)—Regulatory Requirements for Medical Devices (FDA 95-4158) [Available on Disk]August 1, 1995OHIP/DSMADo469
Labeling—Regulatory Requirements for Medical Devices (FDA 89-4203)September 1, 1989OHIP/DSMADo470
In Vitro Diagnostic Devices: Guidance for the Preparation of 510(k) Submissions (FDA 97-4224) [Available on Disk]January 1, 1997OHIP/DSMADo471
Investigational Device Exemptions [IDE] Manual (FDA 96-4159) DSMA [Available on Disk]June 1, 1996OHIP/DSMADo472
Start Printed Page 53909
Regulation of Medical Devices; Background Information for International Officials (Entire Document Available on Disk)April 14, 1999OHIP/DSMADo610
Medical Device Reporting for Manufacturers [Available on Disk]March 1, 1997OHIP/DSMADo987
Premarket Approval (PMA) ManualJanuary 1, 1998OHIP/DSMADo1051
Overview of FDA Modernization Act of 1997 Medical Device Provisions [FDAMA]February 19, 1998OHIP/DSMADo1174
Mutual Recognition Agreement Between the European Union and the United States of America: Confidence Building Programme: Overview and Procedure; Medical Device Annex, Version 7, June 29, 2000; DraftJune 29, 2000OHIP/DSMADo1175
Implementation of Third Party Programs Under the FDA Modernization Act of 1997; Final Guidance for Staff, Industry and Third PartiesFebruary 2, 2001OHIP/DSMADo1160
CDRH Manual for the Good Guidance Practices (GGP) Regulations; Final Guidance for FDA StaffFebruary 9, 2001OHIP Division of Device User Programs and Systems Analysis (DUPSA)Do1323
Human Factors Principles for Medical Device LabelingSeptember 1, 1993OHIP/DUPSADo227
Human Factors Points to Consider for IDE DevicesJanuary 17, 1997OHIP/DUPSADo839
Write It RightAugust 1, 1993OHIP/DUPSADo897
Medical Device Reporting for User FacilitiesApril 1, 1996OHIP/DUPSADo989
Do It By Design—An Introduction to Human Factors in Medical DevicesDecember 1, 1996OHIP/DUPSADo995
Medical Device Use—Safety: Incorporating Human Factors Engineering into Risk Management; Guidance for Industry and FDA Premarket and Design Control ReviewersJuly 18, 2000OHIP/DUPSADo1497
Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA ReviewersApril 19, 2001OHIP/DUPSADo1128
Perspectives on Clinical Studies for Medical Device Submissions (Statistical)Office of Surveillance and Biometrics (OSB) Division of Biostatistics (DB)Do78
PMA Review Statistical Checklist(no date available)OSB/DBDo84
Statistical Aspects of Submissions to FDA: A Medical Device Perspective (Also Includes as Appendix the Article Observed Uses and Abuses of Statistical Procedures in Medical Device SubmissionsJune 1, 1984OSB/DBDo537
MDR Guidance Document: Remedial Action Exemption—E1996001; FinalJuly 30, 1996OSB/DSSDo188
Guidance on Adverse Event Reporting for Hospitals That Reprocess Devices Intended by the Originial Equipment Manufacturer for Single UseApril 24, 2001OSB/DSSDo1334
MDR Guidance Document No. 1-IOL-E1996004; FinalAugust 7, 1996OSB/DSSDo216
MDR Guidance Document No. 3—Needlestick and Blood Exposure—E1996003; FinalAugust 9, 1996OSB/DSSDo250
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Common Problems: Baseline Reports and Medwatch Form 3500AJanuary 1, 1997OSB/DSSDo379
MDR Reporting Guidance for Breast Implants—E1996002; FinalAugust 7, 1996OSB/DSSDo452
Medical Device Reporting: An Overview; FinalApril 1, 1996OSB/DSSDo509
Instructions for Completing FDA Form 3500A With Coding Manual for Form 3500A (MEDWATCH)(MDR); FinalDecember 15, 1995OSB/DSSDo853
MEDWATCH FDA Form 3500A for Use by User Facilities, Distributors and Manufacturers for Mandatory Reporting (MDR); FinalJune 1, 1993OSB/DSSDo854
Variance From Manufacturer Report Number Format [MDR Letter]; FinalJuly 16, 1996OSB/DSSDo1059
Instructions for Completing Form 3417: Medical Device Reporting Baseline Report [MDR]; FinalMarch 31, 1997OSB/DSSDo1061
MDR Internet List Server (listserv) Instruction Sheet; FinalAugust 29, 1996OSB/DSSDo1094
Medical Device Reporting-Alternative Summary Reporting (ASR) Program; Guidance for IndustryOctober 19, 2000OSB/DSSDo315
Addendum to the Instructions for Completing FDA Form 3500A With Coding Manual (MEDWATCH) (MDR); FinalJune 9, 1999OSB/DSSDo1853
Guidance to Sponsors on the Development of a Discretionary Postmarket Surveillance Study for Permanent Implantable Cardiac Pacemaker Electrodes (Leads)June 9, 1993OSB Issues Management Staff (IMS)Do206
Guidance on Criteria and Approaches for Postmarket SurveillanceNovember 2, 1998OSB/IMSDo9
Guidance on Procedures to Determine Application of Postmarket Surveillance Strategies [FDAMA]; FinalFebruary 19, 1998OSB/IMSDo316
Guidance on Procedures for Review of Postmarket Surveillance Submissions [FDAMA]; FinalFebruary 19, 1998OSB/IMSDo317
Guidance for Industry and FDA Staff—SMDA to FDAMA: Guidance on FDA's Transition Plan for Existing Postmarket Surveillance Protocols [FDAMA]; FinalNovember 2, 1998OSB/IMSDo318
Amendment to Guidance on Discretionary Postmarket Surveillance on Pacemaker Leads; FinalMarch 30, 1994OSB/IMSDo374
Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of PostmarketFebruary 2, 2000OSB/IMSDo946
Guidance on Frequently Asked Questions on Recognition of Consensus Standards [FDAMA]December 21, 1998Office of Science and Technology (OST)Do109
Guidance on the Recognition and Use of Consensus Standards/Appendix A [FDAMA]February 19, 1998OSTDo321
A Primer on Medical Device Interactions With Magnetic Resonance Imaging Systems; DraftFebruary 7, 1997OSTDo952
CDRH Standard Operating Procedures for the Identification and Evaluation of Candidate Consensus Standard for RecognitionAugust 6, 1999OSTDo616
Start Printed Page 53911
Guidance on FDA's Expectations of Medical Device Manufacturers Concerning the Year 2000 Date ProblemsMay 15, 1998OSTDo2000
Guidance for Industry and FDA Reviewers: Guidance on Immunotoxicity TestingMay 6, 1999OST Division of Life Sciences (DLS)Do635

Withdrawals

Name of DocumentDate of IssuanceIntended User or ­Regulatory ActivityDate of WithdrawalFOD No.
Guidance for Industry and for FDA Staff: Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals, Draft Guidance—Not for Implementation (Replaced by Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals; Guidance for Industry and for FDA Staff 8/14/00)February 8, 2000OCAugust 8, 2000801029
Guidance on Information Disclosure by Manufacturers to Assemblers for Diagnostic X-Ray Systems; Guidance for Industry (Replaced by Information Disclosure by Manufacturers to Assemblers for Diagnostic X-Ray Systems; Final Guidance for Industry and FDA 4/2/01)October 18, 1999OC/DOEIMarch 30, 2001802619
Final Design Control Report and Guidance (No Replacement)June 1, 1998OC/DOEIIIJuly 24, 2000800949
Working Draft of the Current Good Manufacturing Practice (CGMP) Final Rule (No Replacement)July 1, 1995OC/OTApril 24, 2000800303
Guidance on Amended Procedures for Advisory Panel Meetings [FDAMA]; Final (Replaced by Guidance on Amended Procedures for Advisory Panel Meetings, 7/22/00)January 26, 1999ODEAugust 4, 2000800413
Review Criteria for Assessment of Antimicrobial Susceptibility Devices (Replaced by Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices, 3/8/00)May 31, 1991ODE/DCLDJune 16, 2000800631
Guidance for Premarket Submissions for Kits for Screening Drugs of Abuse to Be Used by the Consumer; Guidance for Industry; Draft (Replaced by Over-the-Counter (OTC) Screening Tests for Drugs of Abuse: Guidance for Premarket Notifications; Guidance for Industry; Draft 11/14/00)December 30, 1998ODE/DCLDOctober 30, 2000802209
Guidance Document for Vascular Prostheses 510(k) Submission; Final (Replaced by Guidance Document for Vascular Prostheses 510(k) Submissions; Guidance for Industry and FDA Staff; Final 11/1/00)November 1, 2000ODE/DCRDJanuary 16, 2000801357
Guidance to Manufacturers on the Development of Required Postapproval Epidemiological Study Protocols for Testicular Implants (No Replacement)Date not availableODE/DCRDJune 15, 2000800202
510(k) Reviewer Guidelines—Tracheostomy Tubes 868.5800 (No Replacement)Date not availableODE/DCRDJune 15, 2000800550
Start Printed Page 53912
Guidance for the Comment and Review of 510(k) Notifications for Picture Archiving and Communications Systems (PACS) and Related Devices (Replaced by Guidance for the Submission of Premarket Notifications for Medical Image Management Devices; Guidance for Industry; Final 7/27/00)August 1, 1993ODE/DCRDAugust 8, 2000800416
Guidance for Industry—Guidance for the Content of Premarket Notifications [510(k)s] for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi (Replaced by Guidance for the Content of Premarket Notifications (510(k)s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi; Final 8/9/00)February 8, 1999ODE/DCRDAugust 10, 2000801226
Guidance for Oxygen Conserving Device 510(k) Review 73 BZD 868.5905 Non-continuous Ventilator Class II (No Replacement)February 1, 1989ODE/DCRDAugust 30, 2000800583
Reviewer's Guidance for Oxygen Concentrator (No Replacement)August 30, 1991ODE/DCRDAugust 30, 2000800781
Guidance Document for Vascular Prostheses 510(k) Submission; Final (Replaced by Guidance Document for Vascular Prostheses 510(k) Submissions; Guidance for Industry and FDA Staff; Final 11/1/00)November 26, 1999ODE/DCRDNovember 16, 2000801357
Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions; Final (Replaced by Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions; Final 11/1/00)January 14, 2000ODE/DCRDJanuary 21, 2000800372
Draft Guidance for Information on Clinical Safety and Effectiveness Data for Extracorporeal Shock Wave Lithotripsy of Upper Urinary Tract (Renal Pelvis, Renal Calyx and Upper Ureteral) Calculi (Replaced by Guidance for the Content of Premarket Notifications (510(k)s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi; Final 8/9/00)February 5, 1992ODE/DCRDJanuary 10, 2001800864
Guidance for Annuloplasty Rings 510(k) Submissions; Final (Replaced by Guidance for Annuloplasty Rings 510(k) Submissions; Final Guidance for Industry and FDA Staff 1/31/01)November 26, 1999ODE/DCRDFebruary 12, 2001801358
Home Uterine Activity Monitors: Guidance for the Submission of 510(k) Premarket Notifications (Replaced by Class II Special Controls Guidance for Home Uterine Activity Monitors; Final Guidance for Industry and FDA Reviewers, 3/9/01)July 30, 1999ODE/DCRDMarch 2001800820
Status Update—Information for Manufacturers Seeking Marketing Clearance of Digital Mammography Systems (Replaced by Premarket Applications for Digital Mammography Systems; Final Guidance for Industry and FDA 2/16/01)February 4, 1999ODE/DCRDFebruary 27, 2001800983
Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for General Purpose Disinfectants (includes Addendum of 3/9, 1994) (No Replacement)October 1, 1993ODE/DDIGDAugust 10, 2000800902
Guidance for the Preparation of Premarket Notification [510(k)] for Resorbable Periodontal Barriers (No Replacement)April 1, 1991ODE/DDIGDSeptember 1, 2000800028
Start Printed Page 53913
Guidance for Spinal System 510(k); Final (Replaced by Guidance for Spinal System 510(k)s 9/27/00)May 7, 1999ODE/DGRNDOctober 2, 2000800636
Guidance for Industry—Guidance Document for Neurological Embolization Devices; Final (Replaced by Guidance for Neurological Embolization Devices; Guidance for Industry; Final 11/1/00)August 13, 1999ODE/DGRNDNovember 7, 2000801151
Ophthalmic Device Triage (No Replacement)March 19, 1998ODE/DOEDJune 20, 2000800160
Announcement by Dr Alpert at 7/26, 1996, Ophthalmic Panel Meeting Concerning Manufacturers and Users of Lasers for Refractive Surgery [Excimer] (No Replacement)August 26, 1996ODE/DOEDJuly 17, 2000803093
Owners Certification of Lasers as PMA Approved Devices [Excimer] (No Replacement)September 26, 1996ODE/DOEDJuly 17, 2000804093
Compliance Guidance—Mammography Facility Survey and Medical Physicist Qualification Requirements Under MQSA (Replaced by Compliance Guidance—Mammography Facility Survey and Medical Physicist Qualification Requirements Under MQSA; Final 11/6/00)May 5, 1999OHIP/DMORPApril 8, 2000806409
A Pocket Guide to Device GMP Inspections—Inspections of Medical Device Manufacturers and GMP Regulation Requirements (No Replacement)November 1, 1991OHIP/DSMAJune 28, 2000800508
Guidance for Staff, Industry, and Third Parties Implementation of Third Party Programs Under the FDA Modernization Act of 1997—June 2000; Draft (Replaced by Implementation of Third Party Programs Under the FDA Modernization Act of 1997; Final Guidance for Staff, Industry and Third Parties 2/2/01)June 12, 2000OHIP/DSMAFebruary 2, 2001801160
Guidance for Industry—Device Use Safety: Incorporating Human Factors in Risk Management (No Replacement)August 3, 1999OHIP/DUPSAJuly 20, 2000801497
Guidance on Medical Device Patient Labeling; Final Guidance for Industry (Replaced by Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers 4/19/01)March 3, 2000OHIP/DUPSAApril 9, 2001801128
MDR Documents Access Information for National Technical Information Service (NTIS) (No Replacement)May 10, 1996OSBJune 28, 2000803799
Proposed Draft Guidance to Sponsors Regarding Required Postmarket Surveillance Studies of Plasma-Sprayed Porous-Coated Hip Prostheses (Archived by OSB—Replaced by Guidance Testing Metallic Plasma Sprayed Orthopedic Implants, 2/2/00)October 7, 1994OSB/DPSJune 16, 2000800323
Letter to Manufacturers: Summary Reporting Approval for Adverse Events; Final (Replaced by Medical Device Reporting—Alternative Summary Reporting (ASR) Program; Guidance for Industry 10/19/00)July 31, 1997OSB/DSSOctober 30, 2000800315
Draft Thermal Endometrial Ablation Devices (Submission Guidance for an IDE) (Replaced by Thermal Endometrial Ablation Devices (Submission Guidance for an IDE); Final 3/14/96))March 14, 1996ODE/DCRDMarch 1996800547
Guidance for Review of Cases of Possible Suspension or Revocation of Mammography Facility Certificates Under the Mammography Quality Standards Act, 42 U.S.C. 263(b)/4/8, 1998 (No Replacement)March 26, 1998OHIP/DMORPMay 23, 2001800080
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Compliance Guidance—Mammography Facility Survey and Medical Physicist Qualification Requirements Under MQSA , Draft (replaced by Compliance Guidance—Mammography Facility Survey and Medical Physicist Qualification Requirements Under MQSA; Final 11/6/00May 5, 1999OHIP/DMORPNovember 8, 2000806409

V. Guidance Documents Issued by the Center for Food Safety and Applied Nutrition (CFSAN)

Name of DocumentDate of IssuanceIntended User or ­Regulatory ActivityHow to Obtain A Hard Copy of the Document (Name and Address, Phone, Fax, E-Mail or Internet)
Compliance Policy Guides Manual1998FDA Regulated IndustriesNational Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, NTIS Order No. PB96-920500
Compliance Programs Guidance Manual1995FDA Regulated IndustriesDo (NTIS Order No. PB95-915499
FDA Recall Policy1995FDA Regulated IndustriesIndustry Activities Staff (HFS-565), Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204
Investigators’ Operations ManualMay 1996FDA Regulated IndustriesNational Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, (NTIS Order No. PB-95-913399)
Regulatory Procedures ManualAugust 1995FDA Regulated IndustriesDo (NTIS Order No. PB95-265534)
Requirements of Laws and Regulations Enforced by the U.S. Food and Drug Administration “Blue Book”1997FDA Regulated IndustriesSuperintendent of Documents, Government Printing Office, Washington, DC 20402
Action Levels for Poisonous or Deleterious Substances in Human Food and Animal Feed1995Food and Animal Feed IndustriesIndustry Activities Staff (HFS-565), Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, (NTIS Order No. PB96-920500)
Pesticides Analytical Manual1996Food IndustryNational Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, (NTIS Order No. PB94-911899)
FDA Advisory for Deoxynivanol (DON) in Finished Wheat Products Intended for Human Consumption and in Grain and Grain By-Products for Animal FeedSeptember 16, 1993Food and Animal Feed IndustriesOffice of Plant and Dairy Foods and Beverages, Food and Drug Administration (HFS-306), 200 C St. SW., Washington, DC 20204, 202-205-4681
FDA’s Cosmetic Labeling ManualOctober 1991Cosmetic IndustryFood and Drug Administration, Office of Colors and Cosmetics (HFS-105), 200 C St. SW., Washington, DC 20204, 202-205-4493
Statement of Policy: Foods Derived From New Plant Varieties: NoticeMay 29, 1992Developers of New Plant Food VarietiesOffice of Premarket Approval, Food and Drug Administration (HFS-200), 200 C St. SW., Washington, DC 20204, 202-418-3100
A Food Labeling GuideMay 1997Food IndustryIndustry Activities Staff (HFS-565), Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202-205-5251
Model Small Business Food Labeling Exemption Notice1998Food IndustryDo
Food Labeling: Questions and AnswersAugust 1994Food IndustryDo
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Food Labeling: Questions and Answers: Volume IIFebruary 1996Food IndustrySuperintendent of Documents, Government Printing Office, Washington, DC 20420, 202-512-1800
Fair Packaging and Labeling Act ManualJune 1978Food IndustryNational Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, 703-487-4650, (NTIS Order No. PB-83-222117)
Bacteriological Analytical Manual 7th Edition1992FDA Regulated IndustriesAOAC International, 481 N. Frederick Ave., suite 500, Gaithersburg, MD 20877-2417, 301-924-7077
FDA Food Importer’s Guide for Low-Acid Canned and Acidified Foods1985Food IndustryIndustry Activities Staff (HFS-565), Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202-205-5251
Evaluation of Milk Laboratories1995StatesMilk Safety Branch (HFS-626), Center for Food Safety and Applied Nutrition, 200 C St. SW., Washington, DC 20204, 202-205-9175
Methods of Making Sanitation Ratings of Milk Supplies1999StatesDo
Dry Milk Ordinance1995StatesDo
Procedures Governing the Cooperative State-Public Health Service/Food and Drug Administration Program for Certification of Interstate Milk Shippers1999Dairy IndustryDo
Frozen Dessert Processing Guidelines1989Dairy IndustryOffice of Plant and Dairy Foods and Beverages (HFS-302), Center for Food Safety and Applied Nutrition, 200 C St. SW., Washington, DC 20204, 202-205-9175
Pasteurized Milk Ordinance1999StatesMilk Safety Branch (HFS-626), Center for Food Safety and Applied Nutrition, 200 C St. SW., Washington, DC 20204, 202-205-9175
Guidelines for Determining Metric Equivalents of Household MeasuresOctober 1, 1993Food IndustryOffice of Nutritional Products, Labeling, and Dietary Supplements, Food and Drug Administration (HFS-800), 200 C St. SW., Washington, DC 20204, 202-205-4561
List of Food Defect Action Levels (DALs)1995Food and Animal Feed IndustriesIndustry Activities Staff (HFS-565), Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202-205-5251
Action Levels for Poisonous or Deleterious Substances in Human Food and Feed (Also Found in CPGs)1995Food and Animal Feed IndustriesDo
FDA Food Code1999StatesNational Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, 703-487-4650
Seafood List1993Seafood IndustrySuperintendent of Documents, Government Printing Office, Washington, DC 20402, 202-512-1800
Manual of Operations National Shellfish Sanitation1992StatesOffice of Seafood (HFS-407), Shellfish Sanitation Branch, 200 C St. SW., Washington, DC 20204, 202-418-3150
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Fish and Fisheries Product Hazards and Control Guide1996Seafood IndustryDo
Guidance for Submitting Requests Under 21 CFR 170.39, Threshold of Regulation for Substances Used in Food Articles1996Food Packaging IndustryOffice of Premarket Approval, Food and Drug Administration (HFS-200), 200 C St. SW., Washington, DC 20204, 202-418-3100
Guidelines for the Preparation of Petition Submissions1996Food Ingredient or Packaging IndustryDo
Guideline for Approval of Color Additives in Contact Lenses Intended as Colors1996Color or Contact Lens IndustryDo
FDA Recommendations for Submission of Chemical and Technological Data on Color Additives for Food, Drugs or Cosmetics UseFebruary 1993Color Additives IndustryDo
Points to Consider for the Use of Recycled Plastics in Food Packaging: Chemistry ConsiderationsDecember 1992Food Packaging IndustryDo
Recommendations for Submission of Chemical and Technological Data for Direct Food Additive and GRAS Food Ingredient PetitionsMay 1993Food Packaging IndustryDo
Recommendations for Chemistry Data for Indirect Food Additive PetitionsJune 1995Food Packaging IndustryDo
Enzyme Preparations: Chemistry Recommendations for Food Additive and GRAS Affirmation PetitionsJanuary 1993Food Enzyme IndustryDo
Estimating Exposure to Direct Food Additive and Chemical Contaminants in the DietSeptember 1995Food and Food Ingredient IndustryDo
Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food (also known as Redbook I)1982Petitioners for Food or Color AdditivesNational Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 2216, (NT IS Order No. PR-83-170696
Environmental Assessment Technical HandbookMarch 1987Petitioners for Food or Color AdditivesDo (NTIS Order No. PB87175345-AS, A-01)
Color Additive Petitions Information and Guidance1996Petitioners for Color AdditivesOffice of Premarket Approval, Food and Drug Administration (HFS-200), 200 C St. SW., Washington, DC 20204, 202-418-3100
Toxological Testing of Food Additives1983Petitioners for Food or Color AdditivesDo
List of Products for Each Product CategoryOctober 8, 1992Food IndustryOffice of Nutritional Products, Labeling, and Dietary Supplements (HFS-800), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-4561
Label Declaration of Allergenic Substances in Foods; Notice to ManufacturersJune 10, 1996Food IndustryDo
Guidance on Labeling of Foods That Need Refrigeration by ConsumersFebruary 24, 1997Food IndustryDo
Guidelines Concerning Notification and Testing of Infant Formula1985Infant Formula ManufacturersDo
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Guidelines for the Evaluation of Safety and Suitability of New Infant Formulas for Feeding Preterm Infants1988Infant Formula ManufacturersDo
Clinical Testing of Infant Formulas With Respect to Nutritional Suitability for Term Infants1988Infant Formula ManufacturersDo
Guidelines for the Evaluation of the Safety and Suitability of Infant Formulas for Feeding Infants With Allergic Diseases1990Infant Formula ManufacturersDo
Guidelines for the Clinical Evaluation of New Products Used in the Dietary Management of Infants, Children and Pregnant Women With Metabolic Disorders1987Infant Formula ManufacturersDo
Guidance Document for Arsenic (Trace Elements in Seafood)January 1993StatesOffice of Seafood, Food and Drug Administration (HFS-400), 200 C St. SW., Washington, DC 20204, 202-418-3150, Internet: FDA Home Page Http://vm.cfsan.fda.gov/​list.html
Guidance Document for Cadmium (Trace Elements in Seafood)January 1993StatesDo
Guidance Document for Chromium (Trace Elements in Seafood)January 1993StatesDo
Guidance Document for Lead (Trace Elements in Seafood)August 1993StatesDo
Guidance Document for Nickel (Trace Elements in Seafood)January 1993StatesDo
Guidance on Consultation Procedures for Foods Derived From New Plant VarietiesOctober 1997Regulated IndustryOffice of Premarket Approval (HFS-200), 200 C St. SW., Washington, DC 20204, 202-418-3100, Internet: FDA Home Page Http://vm.cfsan.fda.gov
FDA’s Policy for Foods Developed by Biotechnology1995Food IndustryDo
Bovine Spongiform Encephalopathy (BSE) in Products for Human Use1997Food IndustryOffice of Plant and Dairy Foods and Beverages (HFS-302), Center for Food Safety and Applied Nutrition, 200 C St. SW., Washington, DC 20204, 202-205-9175, Internet: FDA Home Page Http://www.fda.gov/​opacom/​morechoices/​industry/​guidance/​gelguide.htm
Interim Guidance on the Voluntary Labeling of Milk and Milk Products That Have Not Been Treated With Recombinant Bovine SomatropinFebruary 1994Regulated IndustryOffice of Nutritional Products, Labeling, and Dietary Supplements (HFS-800), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-4168
Shellfish Sanitation Model Ordinance1995StatesShellfish Program Implementation Branch, Division of Cooperative Programs, Office of Field Programs (HFS-628), 200 C St. SW., Washington, DC 20204, 202-205-8137
Guide to Minimize Microbial Hazards for Fresh Fruits and Vegetables (Available in English, Spanish, Portuguese, and French)1998Farmers and Food PackersFood Safety Initiative (HFS-32), Center for Food Safety and Applied Nutrition, 200 C St. SW., Washington, DC 20204, or jsaltsman@bangate.fda.gov
Start Printed Page 53918
Iron-Containing Supplements and Drugs: Label Warning and Unit Dose Packaging; Small Entity Compliance Guide1997Dietary Supplement Manufacturers: Small EntitiesOffice of Nutritional Products, Labeling, and Dietary Supplements (HFS-450), Center for Food Safety and Applied Nutrition, 200 C St. SW., Washington, DC 20204
Partial List of Enzyme Preparations That Are Used in Foods1998FDA Regulated IndustryOffice of Premarket Approval (HFS-200), Center for Food Safety and Applied Nutrition, 200 C St. SW., Washington, DC 20204
Partial List of Microorganisms and Microbial-Derived Ingredients That Are Used in Food1998FDA Regulated IndustryDo
Fish and Fishery Products Hazards and Controls Guide, 2d EditionJanuary 1998FDA Regulated IndustryOffice of Seafood (HFS-400), Center for Food Safety and Applied Nutrition, 200 C St. SW., Washington, DC 20204
HACCP Regulations for Fish and Fishery Products: Questions and Answers1998FDA Regulated IndustryDo
Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body1998FDA Regulated IndustryOffice of Nutritional Products, Labeling, and Dietary Supplements (HFS-150), Center for Food Safety and Applied Nutrition, 200 C St. SW., Washington, DC 20204
FDA Nutrition Labeling Manual, A Guide for Developing and Using Data BasesMarch 1998FDA Regulated IndustryDo
HACCP Regulation for Fish and Fishery Products: Questions and Answers, Issue Three, Revised January 1999January 1999Seafood ProcessorsOffice of Seafood (HFS-400), Center for Food Safety and Nutrition, 200 C St. SW., Washington, DC 20204, Ellen Nesheim, 202-418-3150
Foods—Adulteration Involving Hard or Sharp Foreign Objects (CPG)February 1999FDA Field OfficesOffice of Plant and Dairy Foods and Beverages (HFS-300), Center for Food Safety and Applied Nutrition, 200 C St. SW., Washington, DC 20204
Food Additive Petition Expedited ReviewJanuary 1999Guidance for Industry and Center for Food Safety and Applied Nutrition StaffRobert L. Martin (HFS-215), OPA/CFSAN/FDA, 200 C St. SW., Washington, DC 20204, 202-418-3074, premarkt@cfsan.fda.gov or http://vm.cfsan.fda.gov/​dms/opa-expe.html
Use of Antibiotic Resistance Marker Genes in Transgenic PlantsSeptember 1998Guidance for IndustryNega Beru (HFS-206), OPA/CFSAN/FDA, 200 C St. SW., Washington, DC 20204, 202-418-3097, premarkt@cfsan.fda.gov or http://vm.cfsan.fda.gov/​/dms/opa-armg.html
Guidance: Channels of Trade Policy for Commodities With Methyl Parathion ResiduesDecember 2000Regulated IndustryOffice of Plant and Dairy Foods and Beverages, Center for Food Safety and Applied Nutrition (HFS-300), FDA, 200 C St. SW., Washington, DC 20204, http://vm.cfsan.fda.gov/​`dms
Draft Guidance: Fumonisin Levels in Human Foods and Animal FeedsJune 2000Regulated IndustryDo
Statement of Identity, Nutrition Labeling, and Ingredient Labeling of Dietary Supplements Small Entity Compliance GuideJanuary 1999Small Business EntitiesIndustry Activities Staff (HFS-565), Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202-205-5251
Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements (December 1999)December 1999Regulated IndustryOffice of Nutritional Products, Labeling, and Dietary Supplements, Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202-205-4561
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Antimicrobial Food AdditivesJuly 1999Regulated IndustryOffice of Premarket Approval (HFS-200), Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202-418-3100
Preparation of Premarket Notifications for Food Contact Substances: Chemistry RecommendationsNovember 1999Regulated IndustryDo
Preparation of Premarket Notifications for Food Contact Substances: Toxicology RecommendationsNovember 1999Regulated IndustryDo
Guidance for Small Businesses: Submission of Comments for CFSAN RulemakingOctober 1999Small Business EntitiesDivision of Market Studies (HFS-726), Center for Food Safety and Applied Nutrition, Food and Drug Administration, Washington, DC 20204, 202-401-4590
Warning and Notice Statement: Labeling of Juice Products Small Entity Compliance GuideSeptember 1998Regulated IndustryOffice of Nutritional Products, Labeling, and Dietary Supplements, Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202-205-4561
Reducing Microbial Food Safety Hazards for Sprouted SeedsOctober 1999Regulated IndustryOffice of Plant and Dairy Foods and Beverages, Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202-205-4064
Sampling and Microbial Testing of Spent Irrigation Water During Sprout ProductionOctober 1999Regulated IndustryDo
Seafood HACCP Transition PolicyDecember 1999Regulated IndustryOffice of Seafood (HFS-400), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-3150
FDA Recommendations for Sampling and Testing Yellow Corn Shipments for Cry9C Protein ResiduesJanuary 19, 2001Regulated IndustryOffice of Plant and Dairy Foods and Beverages, Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202-205-4064
Draft Guidance: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using BioengineeringJanuary 2001Regulated IndustryOffice of Premarket Approval (HFS-200), Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202-418-3100
Bacteriological Analytical Manual2001Regulated IndustryDo
Importation of PMO Defined Dairy ProductsApril 11, 2000Dairy IndustryMilk Safety Branch (HFS-626), Center for Food Safety and Applied Nutrition, 200 C St. SW., Washington, DC 20204, 202-205-9175
Draft Guidance: Apple Juice, Apple Juice Concentrates, and Apple Juice Products—Adulteration with PatulinJune 2000Juice IndustryOffice of Plant and Dairy Foods and Beverages, Center for Food Safety and Applied Nutrition, FDA, 200 C St. SW., Washington, DC 20204, 202-205-4064
Draft Guidance for Industry on Refusal of Inspection or Access to HACCP Records Pertaining to the Safe and Sanitary Processing of Fish and Fishery ProductsNovember 2000Seafood IndustryOffice of Seafood (HFS-400), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-3150
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Withdrawals

Name of DocumentDate of Issuance/Date WithdrawnIntended User or ­Regulatory ActivityHow to Obtain A Hard Copy of the Document (Name and Address, Phone, Fax, E-Mail or Internet)
FDA Nutrition Labeling Manual: A Guide for Developing and Using Databases (Replaced by 1998 update with the same title.)1993/June 2001Food IndustryOffice of Nutritional Products, Labeling, and Dietary Supplements, Food and Drug Administration (HFS-800), 200 C St. SW., Washington, DC 20204, 202-205-4561
Fabrication of Single Service Containers and Closures for Milk and Milk Products (Incorporated into Pasteurized Milk Ordinance as an appendix.)1995/June 2001StatesMilk Safety Branch, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-9175

VI. Guidance Documents Issued by the Center for Veterinary Medicine (CVM)

Name of DocumentDate of IssuanceIntended User or ­Regulatory ActivityHow to Obtain a Hard Copy of the Document
Guidance for Industry: Effectiveness of Anthelmintics: Specific Recommendations for Equine (VICH GL15)—DraftSeptember 2000Animal Drug IndustryInternet via: http://www.fda.gov/​cvm Communications Staff (HFV-12), FDA/CVM, 7500 Standish Pl., Rockville, MD 20855, 301-827-4582, FAX 301-594-1831
Guidance for Industry: Effectiveness of Anthelmintics: Specific Recommendations for Porcine (VICH GL16)—DraftSeptember 2000DoDo
Guidance for Industry: Effectiveness of Anthelmintics: Specific Recommendations for Canine (VICH GL19)—DraftSeptember 2000DoDo
Guidance for Industry: Effectiveness of Anthelmintics: Specific Recommendations for Feline (VICH GL20)—DraftDecember 2000DoDo
Guidance for Industry: Effectiveness of Anthelmintics: Specific Recommendations for Poultry (VICH GL21)—DraftDecember 2000DoDo
Guidance for Industry: Safety Studies for Veterinary Drug Residues in Human Food: Reproduction Studies (VICH GL22)—DraftDecember 2000DoDo
Guidance for Industry: Safety Studies for Veterinary Drug Residues in Human Food: Genotoxicity Studies (VICH GL23)—DraftDecember 2000DoDo
Guidance for Industry: Pharmacovigilance of Veterinary Medicinal Products: Management of Adverse Event Reports (AERs)(VICH GL24)—DraftDecember 2000DoDo
Guidance for Industry: Efficacy of Anthelmintics: General Recommendations (VICH GL7)—FinalMarch 2000DoDo
Guidance for Industry: Efficacy of Anthelmintics: Specific Recommendations for Bovines (VICH GL12)—FinalMarch 2000DoDo
Guidance for Industry: Efficacy of Anthelmintics: Specific Recommendations for Ovines (VICH GL13)—FinalMarch 2000DoDo
Guidance for Industry: Efficacy of Anthelmintics: Specific Recommendations for Caprines (VICH GL14)—FinalMarch 2000DoDo
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Guidance for Industry: Environmental Impact Assessments (EIAs) for Veterinary Medicinal Products (VMPs)—Phase I (VICH GL6)—FinalMarch 2000DoDo
Guidance for Industry: Stability Testing of New Biotechnological/Biological Veterinary Medicinal Products (VICH GL17)—FinalMarch 2000DoDo
Guidance for Industry: Good Clinical Practices (VICH GL9)—FinalMay 2000DoDo
Guidance for Industry: Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients (VICH GL18)—FinalMay 2000DoDo
Guidance for Industry: How to Use E-Mail to Submit a Notice of Final Disposition of Animals Not Intended for Immediate Slaughter (NFDAs)February 2000DoDo
Guidance for Industry: How to Use E-Mail to Submit a Notice of Intent to Slaughter for Human Food PurposesFebruary 2000DoDo
Guidance for Industry: How to Use E-Mail to Submit a Request for a Meeting or Teleconference to the Office of New Animal Drug EvaluationFebruary 2000DoDo
How to Use E-Mail to Submit Information to the Center for Veterinary Medicine—FinalFebruary 2000DoDo
Dioxin in Anti-Caking Agents Used in Animal Feed and Feed IngredientsRevised April 2000DoDo
Guidance for Industry: Fumonisin Levels in Human Foods and Animal Feeds—DraftJune 2000DoDo
The Use of Published Literature in Support of New Animal Drug ApprovalNovember 2000DoDo
Guidance for Industry: Bioequivalence GuidanceRevised October 2000DoDo
Guidance for Industry #124: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering—DraftJanuary 2001DoDo
Guidance for Industry #126: BACPAC I: Intermediates in Drug Substance Synthesis Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation, February 2001February 2001DoDo
Guidance for Industry #120: Veterinary Feed Directive RegulationMarch 2001DoDo
Guidance for Industry #121: Expedited Review for New Animal Drug Applications for Human Pathogen Reduction ClaimsMarch 2001DoDo
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Guidance for Industry and Reviewers: How the Center for Veterinary Medicine Intends to Handle Deficient Submissions Filed During the Investigation of a New Animal Drug—DraftMarch 2001DoDo

VII. Guidance Documents Issued by the Office of Policy (OP)

Name of DocumentDate of IssuanceIntended User or ­Regulatory ActivityHow to Obtain a Hard Copy of the Document
Draft Guidance for Industry; Exports and Imports Under the FDA Export Reform and Enhancement Act of 1996June 12, 1998Regulated IndustryInternet via www.fda.gov/​opacom/​fedregister/​frexport.html or 63 FR 32219, June 12, 1998, or Office of Policy, 301-827-3360
Direct Final Rule GuidanceNovember 21, 1997FDA PersonnelInternet via www.fda.gov/​opacom/​morechoices/​industry/​guidance.htm or 62 FR 62467, November 21, 1997, or Office of Policy, 301-827-3480
International Harmonization; Policy on StandardsOctober 1995FDA Personnel and Regulated Industry60 FR 53078, October 11, 1995, or Office of Policy, 301-827-3360

Withdrawals

Name of DocumentDate of IssuanceIntended User or ­Regulatory ActivityDate Withdrawn
FDA's Development, Issuance and Use of Guidance DocumentsFebruary 27, 1997FDA Personnel and Regulated IndustrySeptember 19, 2000
Small Entities Compliance Guide On: Regulations To Restrict the Sale and Distribution of Cigarettes and Smokeless Tobacco in Order to Protect Children and Adolescents (21 CFR Part 897)February 1997Regulated IndustryMarch 31, 2000
Children and Tobacco—Frequently Asked Questions About the New Regulations (Draft)July 1997Regulated IndustryMarch 31, 2000
Children and Tobacco—A Retailers Guide to the New Federal RegulationsOctober 1997Regulated IndustryMarch 31, 2000
Children and Tobacco—A Guide to the New Federal RegulationsOctober 1997Regulated IndustryMarch 31, 2000

VIII. Guidance Documents Issued by the Office of Regulatory Affairs (ORA)

Name of DocumentDate of IssuanceIntended User or ­Regulatory ActivityHow to Obtain a Hard Copy of the Document
Compliance Policy Guide Manual—Compliance Policy Guidance for FDA Staff (Replaces Compliance Policy Guide—January 1996)August 2000FDA StaffNational Technical Information Service (NTIS) 5285 Port Royal Rd., Springfield, VA 22161 or Internet at: www.fda.gov/​ora/​cpgm/​default.html
Compliance Policy Guide, New Sec. 615.115 Extra-Label Use of Medicated Feeds for Minor SpeciesApril 2001DoDivision of Compliance Policy (HFC-230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0420 or via Internet at: www.fda.gov/​ora/​compliance;​ref/​rpm/​rpmtc.html
Start Printed Page 53923
Compliance Policy Guide, New Sec. 555.250 Statement of Policy for Labeling and Preventing Cross-Contact of Common Food AllergensApril 2001DoDo
Compliance Policy Guide, Reformat Sec. 220.100 Interstate Shipment of Biological Products for Use in Medical EmergenciesMarch 2001DoDo
Compliance Policy Guide, Reformat Sec. 270.100 Final Container Labels—Allergenic Extracts Containing Glycerin; Reporting ChangesMarch 2001DoDo
Compliance Policy Guide, Draft Sec. 230.150, Blood Donor IncentivesDecember 2000DoDo
Compliance Policy Guide, Draft Distributor Medical ReportingAugust 28, 1997FDA Staff Personnel and Regulated IndustryDo Internet at: www.fda.gov/​ora/​compliance;​ref/​cpg;​mdr3.txt
Compliance Policy Guide Sec. 7150.09 Fraud, Statements of Material Facts, Bribery, and Illegal GratuitiesJuly 1991FDA Staff and Regulated IndustryDo Internet at: www.fda.gov/​ora/​compliance;​ref/​aip;​page.html
Medical Device Warning Letter PilotMarch 8, 1999FDA Staff and Regulated IndustryDo Internet at: www.fda.gov/​ohrms/​Dockets/​98fr/​030899e.pdf
Glossary of Computerized System and Software Development TerminologyAugust 1995DoNational Technical Information Service (NTIS) 5285 Port Royal Rd., Springfield, VA 22161 (NTIS Order No. PB96-127352) or via Internet: www.fda.gov/​ora/​inspect;​ref/​igs/​iglist.html
Guidelines for Entry Review of Radiation-Emitting Electronic DevicesMarch 12, 1999FDA StaffDivision of Import Operations and Policy (HFC-170), Office of Regional Operations, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-1218
Laboratory Procedures ManualJune 1994DoDivision of Field Science (HFC-141), Food and Drug Administration, 5600 Fishers Lane, rm. 12-41, Rockville, MD 20857, or Internet at: www.fda.gov/​ora/​science;​ref/​lpm/​lpmtc.html
Laboratory Procedures Manual Chapter X, New: Method Validation SamplesMay 1999DoDo
Memorandum: ORA Investigational Strategy on Gamma-Butyrolactone (GBL) and Related ProductsMay 15, 2000DoDivision of Emergency and Investigational Operations (HFC-130), Office of Regional Operations, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, Not Available on the Internet
Investigations Operations ManualJanuary 2001DoNational Technical Information Service (NTIS) 5285 Port Royal Rd., Springfield, VA 22161 (NTIS Order No. PB2001-913399 and Internet at www.fda.gov/​ora/​inspect;​ref/​iom/​default.htm)
Medical Devices: Draft Guidance entitled “Guidance for FDA Staff on Civil Money Penalty Policy”Released for Comment June 8, 1999FDA StaffDivision of Compliance Policy (HFC-230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0420, or Internet at: http://www.fda.gov/​ohrms/​dockets/​98fr/​060899e.pdf
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Regulatory Procedures Manual Update/New Subchapter 5 Civil Money Penalty Reduction Policy for Small EntitiesApril 19, 2001DoDo Internet at: www.fda.gov/​ora/​compliance;​ref/​rpm/​rpmtc.html
Regulatory Procedures Manual New RPM Subchapter: Communication Concerning Assessment of Civil Monetary Penalties by U.S. Customs Service in Cases Involving Imported FoodJanuary 2001DoDo Internet at: www.fda.gov/​ora/​compliance;​ref/​rpm/​rpmtc.html
Regulatory Procedures Manual: Update, New Subchapter Application Integrity PolicyMarch 1998DoDivision of Compliance Policy (HFC-230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0420 or via Internet at: www.fda.gov/​ora/​compliance;​ref/​rpm/​rpmtc.html
Regulatory Procedures Manual: Update/Revision Subchapter/Priority Enforcement Strategy for Problem ImportersApril 1998DoDo
Regulatory Procedures Manual: Update/Revision Subchapter/Import ProceduresApril 1998DoDo
Regulatory Procedures Manual: Update/Revision Subchapter/Notice of SamplingApril 1998FDA StaffDo
Regulatory Procedures Manual: Update New Subchapter/Granting and Denying Transportation and Exportation (TE) EntriesMay 1998DoDo
Regulatory Procedures Manual: Update/Revision Subchapter/SeizureJune 1998DoDo Internet at: www.fda.gov/​ora/​compliance;​ref/​rpm;​new2/​ch6.html
Regulatory Procedures Manual: Update/Revision Subchapter/Supervisory ChargesJune 1998DoDo Internet at: www.fda.gov/​ora/​compliance;​ref/​new2/​ch9chgs.html
Regulatory Procedures Manual: New Subchapter: Civil Penalties—Electronic Product Radiation ControlJuly 1998DoDo Internet at: www.fda.gov/​ora/​compliance;​ref/​ch6civpen.html
Regulatory Procedures Manual: Update/Revision, Chapter 4, Subchapter/Warning LettersMarch 21, 2000DoDo Internet at: www.fda.gov/​ora/​compliance;​ref/​rpm;​new2/​ch4.html
Regulatory Procedures Manual New Chapter 9, Communication Concerning Assessment of Civil Monetary Penalties by U.S. Customs in Cases Involving Imported FoodJanuary 2001DoDo Internet at: www.fda.gov/​ora/​compliance;​ref/​rpm;​new2/​ch9civmonpen.html
Regulatory Procedures Manual New Chapter 9, Secured StorageJanuary 2001DoDo Internet at: www.fda.gov/​ora/​compliance;​ref/​rpm;​new2/​ch9securedstorage.html
Guide to Inspections of Bulk Pharmaceutical ChemicalsMay 1994DoNational Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, (NTIS Order No. PB96-127154) or via Internet at: www.fda.gov/​ora/​inspect);​ref/​igs/​iglist.html
Guide to Inspections of Pharmaceutical Quality Control LaboratoriesJuly 1993DoDo (NTIS Order No. PB96-127279) or via Internet at: www.fda.gov/​ora/​inspect;​ref/​igs/​iglist.html
Start Printed Page 53925
Guide to Inspections of Microbiological Pharmaceutical Quality Control LaboratoriesJuly 1993DoDo (NTIS Order No. PB96-127287) or via Internet at: www.fda.gov/​ora/​inspect;​ref/​igs/​iglist.html
Guide to Inspections of Validation of Cleaning ProcessesJuly 1993DoDo (NTIS Order No. PB96-127246) or via Internet at: www.fda.gov/​ora/​inspect;​ref/​igs/​iglist.html
Guide to Inspections of Lyophilization of ParenteralsJuly 1993DoDo (NTIS Order No. PB96-127253) or via Internet at: www.fda.gov/​ora/​inspect;​ref/​igs/​iglist.html
Guide to Inspections of High Purity Water SystemsJuly 1993DoDo (NTIS Order No. PB96-127261) or via Internet at: www.fda.gov/​ora/​inspect;​ref/​igs/​iglist.html
Guide to Inspections of Dosage Form Drug Manufacturers—CGMPsOctober 1993DoDo (NTIS Order No. PB96-127212) or via Internet at: www.fda.gov/​ora/​inspect;​ref/​igs/​iglist.html
Guide to Inspections of Oral Solid Dosage Forms Pre/Post Approval Issues for Development and VaccinationJanuary 1994DoDo (NTIS Order No. PB96-127345) or via Internet at: www.fda.gov/​ora/​inspect;​ref/​igs/​iglist.html
Guide to Inspections of Topical Drug ProductsJuly 1994DoDo (NTIS Order No. PB96-127394) or via Internet at: www.fda.gov/​ora/​inspect;​ref/​igs/​iglist.html
Guide to Inspections of Sterile Drug Substance ManufacturersJuly 1994DoDo (NTIS Order No. PB96-127295) or via Internet at: www.fda.gov/​ora/​inspect;​ref/​igs/​iglist.html
Guide to Inspections of Oral Solutions and SuspensionsAugust 1994DoDo (NTIS Order No. PB96-127147) or via Internet at: www.fda.gov/​ora/​inspect;​ref/​igs/​iglist.html
Guide to Inspections of Nutritional Labeling and Education Act (NLEA) RequirementsFebruary 1995DoDo (NTIS Order No. PB96-127378) or via Internet at: www.fda.gov/​ora/​inspect;​ref/​igs/​iglist.html
Guide to Inspections of Interstate Carriers and Support FacilitiesApril 1995DoDo (NTIS Order No. PB96-127386) or via Internet at: www.fda.gov/​ora/​inspect;​ref/​igs/​iglist.html
Guide to Inspections of Dairy Product ManufacturersApril 1995DoDo (NTIS Order No. PB96-127329) or via Internet at: www.fda.gov/​ora/​inspect;​ref/​igs/​iglist.html
Guide to Inspections of Miscellaneous Foods Vol. 1May 1995DoDo (NTIS Order No. PB97-127220) or via Internet at: www.fda.gov/​ora/​inspect;​ref/​igs/​iglist.html
Guide to Inspections of Miscellaneous Foods Vol. 11September 1996DoDo (NTIS Order No. PB97-196133) or via Internet at: www.fda.gov/​ora/​inspect;​ref/​igs/​iglist.html
Guide to Inspections of Low Acid Canned Foods Manufacturers, Part 1—Administrative Procedures/Scheduled ProcessesNovember 1996DoDo (NTIS Order No. PB97-196141) or via Internet at: www.fda.gov/​ora/​inspect;​ref/​igs/​iglist.html
Guide to Inspections of Cosmetic Product ManufacturersFebruary 1995DoDo (NTIS Order No. PB96-127238) or via Internet at: www.fda.gov/​ora/​inspect;​ref/​igs/​iglist.html
Guide to Inspections of Low Acid Canned Foods Manufacturers, Part 2—Processes/ ProceduresApril 1997DoDo (NTIS Order No. PB97-196158) or via Internet at: www.fda.gov/​ora/​inspect;​ref/​igs/​iglist.html
Start Printed Page 53926
Guide to Inspections of Low Acid Canned Foods Manufacturers, Part 3—Container ClosurersJuly 2001FDA StaffDo (NTIS Order No. PB00-133795)
Guide to Inspections of Blood BanksSeptember 1994DoDo (NTIS Order No. PB96-127303) or via Internet at: www.fda.gov/​ora/​inspect;​ref/​igs/​iglist.html
Guide to Inspections of Source Plasma EstablishmentsDecember 1994DoDo (NTIS Order No. PB96-127360) or via Internet at: www.fda.gov/​ora/​inspect;​ref/​igs/​iglist.html
Guide to Inspections of Infectious Disease Marker Testing FacilitiesJune 1996DoDo (NTIS Order No. PB96-199476) or via Internet at: www.fda.gov/​ora/​inspect;​ref/​igs/​iglist.html
Biotechnology Inspections GuideNovember 1991DoDo (NTIS Order No. PB96-127402) or via Internet at: www.fda.gov/​ora/​inspect;​ref/​igs/​iglist.html
Guide to Inspections of Computerized Systems in Drug ProcessingFebruary 1983DoDo (NTIS Order No. PB96-127337) or via Internet at: www.fda.gov/​ora/​inspect;​ref/​igs/​iglist.html
Guide to Inspections of Foreign Medical Device ManufacturersSeptember 1995DoDo (NTIS Order No. PB96-127311) or via Internet at: www.fda.gov/​ora/​inspect;​ref/​igs/​iglist.html
Guide to Inspections of Foreign Pharmaceutical ManufacturersMay 1996DoDo (NTIS Order No. PB96-199468) or via Internet at: www.fda.gov/​ora/​inspect;​ref/​igs/​iglist.html
Mammography Quality Standards Act (MQSA) Auditors GuideJanuary 1998DoDo (NTIS Order No. PB98-127178) or via Internet at: www.fda.gov/​ora/​inspect;​ref/​igs/​iglist.html
Guide to Inspections of Electromagnetic Compatibility Aspects of Medical Device Quality SystemsDecember 1997DoDo (NTIS Order No. PB98-127152) or via Internet at: www.fda.gov/​ora/​inspect;​ref/​igs/​iglist.html
Guide to Inspections of Acidified Food ManufacturersMay 1998Dohttp://www.fda.gov/​ora/​inspect;​ref/​igs/​acidfgde.htm
Guide to Inspection of Aseptic Processing and Packaging for the Food IndustryFebruary 2001DoDivision of Emergency and Investigational Operations (HFC-130), Office of Regional Operations, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-1240
Guide to Inspections of Grain Product ManufacturersMarch 1998Do(NTIS Order No. PB-98-137128) or via Internet at: www.fda.gov/​ora/​inspect;​ref/​igs/​iglist.html
Guide to Bioresearch Monitoring Inspections of In Vitro DevicesFebruary 1998DoDo Internet at: www.fda.gov/​ora/​inspect;​ref/​igs/​iglist.html
Guide to Inspections of Viral Clearance Processes for Plasma DerivativesMarch 1998DoDo Internet at: www.fda.gov/​ora/​inspect;​ref/​igs/​iglist.html
Guide to Trace Back of Fresh Fruits and Vegetables Implicated in Epidemiological InvestigationsApril 2001DoDo Internet at: www.fda.gov/​ora/​inspect;​ref/​igs/​iglist.html
Guide to Inspections of Computerized Systems in the Food Processing IndustryAugust 1998DoDo Internet at: www.fda.gov/​ora/​inspect;​ref/​igf/​foodcomp.html
Guide to International Inspections and Travel, Revision (Formerly, FDA/ORA International Inspection Manual and Travel Guide)July 1999DoDo Revision not available on Internet
Start Printed Page 53927
Guide to Inspections of Quality SystemsAugust 1999DoDo Internet at: www.fda.gov/​ora/​inspect;​ref/​igs/​qsit/​QSITGUIDE.PDF
Guide to Inspection of Firms Producing Food Products Susceptible to Contamination with Allergenic IngredientsApril 2001DoDo Internet at: http://www.fda.gov/​ora/​inspect;​ref/​igs/​iglist.html
Computerized Systems Used in Clinical TrialsApril 1999DoDo Internet at: www.fda.gov/​ora/​compliance;​ref/​bimo/​ffinalact.html
Compliance Program 7348.001: Bioresearch Monitoring, Human Drugs, In Vivo BioequivalenceOctober 1, 1999D0Do Internet at: www.fda.gov/​ora/​compliance;​ref/​Bimo/​7348;​001/​default.html
Good Laboratory Practice Program (Nonclinical Laboratories) 7348.808A; EPA Data Audit InspectionsOctober 1, 1991DoDivision of Compliance Policy (HFC-230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0420
Guideline for the Monitoring of Clinical InvestigatorsJanuary 1988FDA Regulated IndustryDivision of Compliance Policy (HFC-230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0420
Small Business Guide to FDA (FDA 96-1092)January 1, 1996DoFederal-State Relations (HFC-150), Office of Regulatory Affairs, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-2905 Internet at: www.fda.gov/​ora/​indust;​assit/​default.htm
Compliance Program 7348.808 Bioresearch Monitoring: Good Laboratory Practices (Nonclinical)Revised August 17, 1998FDA StaffDo Internet at: www.fda.gov/​ora/​compliance;​ref/​bimo/​default.html
Compliance Program 7348.809 Bioresearch Monitoring: Institutional Review BoardAugust 18, 1994DoDo
Compliance Program 7348.810: Sponsors, Contract Research Organizations and MonitorsRevised October 30, 1998DoDo
Good Laboratory Practice Regulations Management BriefingsAugust 1979DoDo Internet at: www.fda.gov/​ora/​compliance;​ref/​bimo/​default.html
Draft: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency ResearchMarch 31, 2000FDA Regulated IndustryDo
Start Signature

Dated: October 9, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. 01-26650 Filed 10-23-01; 8:45 am]

BILLING CODE 4160-01-S