Skip to Content

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.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble Start Printed Page 45428

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is publishing an annual comprehensive list of all guidance documents currently in use at the agency. We committed to publishing this list in our February 1997 “Good Guidance Practices” (GGP's), which set forth our policies and procedures for developing, issuing, and using guidance documents. This list is intended to inform the public of the existence and availability of all our current guidance documents.

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. We have provided information on where to obtain a single copy of any of the guidance documents listed in the specific Center's list of guidance documents.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

LaJuana D. Caldwell, Office of Policy, Planning, and Legislation (HF-27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7010.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of February 27, 1997 (62 FR 8961), we announced our GGP's—our policies and procedures for developing, issuing, and using guidance documents. We adopted the GGP's to ensure your involvement in the development of guidance documents and to enhance your understanding of the availability, nature, and legal effect of such guidance.

As part of our effort to ensure meaningful interaction with the public regarding guidance documents, we committed to publish an annual comprehensive list of guidance documents and quarterly updates that list all guidance documents that were issued and withdrawn during that quarter, including “Level 2” guidance documents.

A. Plain Language in Guidance Documents

On June 1, 1998, the President instructed all Federal agencies to ensure the use of “plain language” in all new documents. As part of this initiative, We use the principles of “plain language” set forth by the President when writing our guidance documents. We seek your comments on the clarity of our guidances.

B. How the List is Organized

The following comprehensive list of guidance documents represents all guidances currently in effect. This comprehensive list is maintained on the FDA Internet home page. We will update and publish this list in the Federal Register every year. We organized the guidance documents in this comprehensive list by the issuing Center or Office within FDA, and we further grouped them by 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. We also provide document numbers when they are available.

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

Name of DocumentDate of IssuanceGrouped by Intended 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
Start Printed Page 45429
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
Deferral of Donors Who Have Received Human Pituitary-Derived Growth HormoneNovember 25, 1987DoDo
Start Printed Page 45430
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-1 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
PTC in the Collection, Processing and Testing of Ex Vivo Activated Mononuclear Leukocytes for Administration to HumansAugust 22, 1989DoDo
Start Printed Page 45431
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 Positive Tests 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 & 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 & 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
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
Start Printed Page 45432
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 Reagents 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
Alternatives to Lot ReleaseJuly 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
Start Printed Page 45433
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 IND's 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, (Publication 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 Blood Establishment Computer Software ManufacturersMarch 31, 1994DoDo
To Sponsors of IND's 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
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
Start Printed Page 45434
Use of and FDA Cleared or Approved Sterile Docking Device (STCD) in Blood Bank Practices (transmittal memo 8/12/94) (corrects 7/29/94 Memo)August 5, 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
To Blood Establishment Computer Software ManufacturersFebruary 10, 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 August 27, 1982 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
Reviewer Guidance, Computer SoftwareMarch 26, 1995FDA PersonnelDo
Start Printed Page 45435
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, 1995FDA Regulated IndustryDo
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 HighRisk 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
Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived ProductsNovember 1, 1995FDA Regulated IndustryDo
Guidance Concerning Conversion to FDA-Reviewed Software ProductsNovember 13, 1995DoDo
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
Start Printed Page 45436
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
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
Start Printed Page 45437
To Manufacturers: HIV-1 Group OJuly 31, 1996DoDo
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
Draft Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation; NoticeSeptember 23, 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
The Food and Drug Administration's Development, Issuance, and Use of Guidance DocumentsFebruary 27, 1997FDA Regulated IndustryDo
Proposed Approach to Regulation of Cellular and Tissue-Based ProductsFebruary 27, 1997DoDo
PTC in the Manufacture and Testing of Monoclonal Antibody Products for Human UseFebruary 28, 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
Start Printed Page 45438
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
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 Validatioin 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
Draft Guidance for Industry on Testing Limits in Stability Protocols for Standardized Grass Pollen ExtractsAugust 1997DoDo
Start Printed Page 45439
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
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
ICH Draft Guidance on Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical SubstancesNovember 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
Start Printed Page 45440
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 Carncinogenicity 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
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: Submitting and Reviewing Complete Responses to Clinical HoldsMay 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
Start Printed Page 45441
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
Draft Guidance for Industry: Recommendations for Collecting Red Blood Cells by Automated Apheresis MethodsJuly 1998DoDo
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
Draft Guidance for Industry: Developing Medical Imaging Drugs and BiologicsOctober 1998DoDo
Guidance for Industry: on Advisory Committees: Implementing Section 120 of the Food and Drug Administration Act of 1997October 1998DoDo
Draft Document: United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128December 1997 (Released November 1998)DoDo
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
Start Printed Page 45442
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
Guidance for Industry: Providing Regulatory Submissions in Electronic Format—General ConsiderationsJanuary 1999DoDo
Guidance for Industry: Population PharmacokineticsFebruary 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: 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
Start Printed Page 45443
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
Draft Guidance for Industry: Monoclonal Antibodies Used as Reagents in Drug ManufacturingMay 1999DoDo
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
Start Printed Page 45444
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
International Conference on Harmonisation Draft Guidance; Choice of Control Group in Clinical TrialsSeptember 24, 1999DoDo
Draft 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 VectorsNovember 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 Harmonisation 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
Start Printed Page 45445
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
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; E11: Clinical Investigation of Medicinal Products in the Pediatric PopulationApril 12, 2000DoDo
International Conference on Harmonisation; Draft Revised Guidance on Q1A(R) Stability Testing of New Drug Substances and ProductsApril 21, 2000DoDo

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

Name of DocumentDate of IssuanceGrouped by Intended User or Regulatory ActivityHow to Obtain a Hard Copy of the Document (Name and Address, Phone, FAX, E-mail or Internet)
Accelerated Approval Products—Submission of Promotional MaterialsMarch 26, 1999Advertising Drafthttp://www.fda.gov/​cder/​guidance/​index.htm
Product Name, Placement, Size, and Prominence in Advertising and Promotional LabelingMarch 12, 1999DoDo
Promoting Medical Products in a Changing Healthcare Environment; Medical Product Promotion by Healthcare Organizations or Pharmacy Benefits Management Companies (PBMs)January 5, 1998DoDo
Aerosol Steroid Product Safety Information in Prescription Drug Advertising and Promotional LabelingJanuary 12, 1998AdvertisingDo
Start Printed Page 45446
Consumer-Directed Broadcast AdvertisementsAugust 9, 1999DoDo
Antifungal (topical)February 24, 1990Biopharmaceutic DraftDo
Antifungal (vaginal)February 24, 1990DoDo
Average, Population, and Individual Approaches to Establishing BioequivalenceAugust 27, 1999DoDo
Bioanalytical Methods Validations for Human StudiesJanuary 5, 1999DoDo
Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local ActionJune 2, 1999DoDo
Bioavailability and Bioequivalence Studies for Orally Administered Drug ProductsAugust 27, 1999DoDo
Conjugated Estrogens, USP: LC-MS Method for Both Qualitative Chemical Characterization and Documentation of Qualitative Pharmaceutical EquivalenceMarch 9, 2000DoDo
Food-Effect Bioavailability and Bioequivalence StudiesDecember 20, 1997DoDo
Topical Dermatological Drug Product NDA's and ANDA's—In Vivo Bioavailability, Bioequivalence, In Vitro Release and Associated StudiesJune 18, 1998DoDo
Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Containing Certain Active Moieties/Active IngredientsFebruary 17, 1999DoDo
Buspirone Hydrochloride Tablets In Vivo Bioequivalence and In Vitro Dissolution TestingMay 15, 1998BiopharmaceuticDo
Cholestyramine Powder In Vitro BioequivalenceJuly 15, 1993DoDo
Cimetidine Tablets In Vivo Bioequivalence and In Vitro Dissolution TestingJune 12, 1992DoDo
Clozapine (Tablets) In Vivo Bioequivalence and In Vitro Dissolution TestingNovember 15, 1996DoDo
Corticosteroids, Dermatologic (topical) In VivoJune 2, 1995DoDo
Diclofenac Sodium (tablets) In Vivo Bioequivalence and In Vitro Dissolution TestingOctober 6, 1994DoDo
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
Glipizide (Tablets) In Vivo Bioequivalence and In Vitro Dissolution TestingApril 23, 1993DoDo
Glyburide Tablets In Vivo Bioequivalence and In Vitro Dissolution TestingApril 23, 1993DoDo
Metaproterenol Sulfate and Albuterol Metered Dose Inhalers In VitroJune 27, 1989DoDo
Start Printed Page 45447
Oral Extended (Controlled) Release Dosage Forms In Vivo Bioequivalence and In Vitro Dissolution TestingSeptember 9, 1993DoDo
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 Procedure for Bioequivalence Studies Using a Standard Two-Treatment Crossover DesignJuly 1, 1992DoDo
BACPAC I: Intermediates in Drug Substance Synthesis (Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation)November 30, 1998Chemistry DraftDo
IND Meetings for Human Drugs and Biologics; Chemistry, Manufacturing, and Controls InformationFebruary 4, 2000DoDo
IND's for Phase 2 and 3 Studies of Drugs, Including Specified Therapeutic Biotechnology-Derived Products; Chemistry, Manufacturing, and Controls Content and FormatApril 20, 1999DoDo
Metered Dose Inhalers (MDI) and Dry Powder Inhalers (DPI) Drug Products; Chemistry, Manufacturing, and Controls DocumentationNovember 19, 1998DoDo
Monoclonal Antibodies Used as Reagents in Drug ManufacturingJune 24, 1999DoDo
Nasal Spray and Inhalation Solution, Suspension, and Spray Drug ProductsJune 2, 1999DoDo
Stability Testing of Drug Substances and Drug ProductsJune 8, 1998DoDo
Submitting Supporting Chemistry Documentation in Radiopharmaceutical Drug ApplicationsNovember 1, 1991DoDo
SUPAC-SS: Nonsterile Semisolid Dosage Forms Manufacturing Equipment AddendumJanuary 5, 1999DoDo
Tracking of NDA and ANDA Reformulations for Solid, Oral, Immediate Release Drug ProductsDoDo
Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological ProductsJuly 24, 1997ChemistryDo
Changes to an Approved NDA or ANDANovember 23, 1999DoDo
Container Closure Systems for Packaging Human Drugs and BiologicsJuly 7, 1999DoDo
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
Start Printed Page 45448
FDA's Policy Statement for the Development of New Stereoisomeric DrugsMay 1, 1992DoDo
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
Format and Content of the Microbiology Section of an ApplicationFebruary 1, 1987DoDo
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 SubstancesFebruary 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 TestingNovember 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 45449
Acute Bacterial Exacerbation of Chronic Bronchitis; Developing Antimicrobial Drugs for TreatmentJuly 22, 1998Clinical Antimicrobial DraftDo
Acute Bacterial Meningitis; Developing Antimicrobial Drugs for TreatmentJuly 22, 1998DoDo
Acute Bacterial Sinusitis; Developing Antimicrobial Drugs for TreatmentJuly 22, 1998DoDo
Acute Otitis Media; Developing Antimicrobial Drugs for TreatmentJuly 22, 1998DoDo
Bacterial Vaginosis; Developing Antimicrobial Drugs for TreatmentJuly 22, 1998DoDo
Catheter-Related Bloodstream Infections—Developing Antimicrobial Drugs for TreatmentOctober 18, 1999DoDo
Clinical Considerations for Accelerated and Traditional Approval of Antiretroviral Drugs Using Plasma HIV RNA MeasurementsSeptember 1, 1999DoDo
Community Acquired Pneumonia; Developing Antimicrobial Drugs for TreatmentJuly 22, 1998DoDo
Complicated Urinary Tract Infections and Pylonephritis; Developing Antimicrobial Drugs for TreatmentJuly 22, 1998DoDo
Developing Antimicrobial Drugs-General Considerations for Clinical TrialsJuly 22, 1998DoDo
Empiric Therapy of Febrile Neutropenia; Developing Antimicrobial Drugs for TreatmentJuly 22, 1998DoDo
Evaluating Clinical Studies of Antimicrobials in the Division of Anti-Infective Drug ProductsFebruary 17, 1997DoDo
Lyme Disease; Developing Antimicrobial Drugs for TreatmentJuly 22, 1998DoDo
Nosocomial Pneumonia; Developing Antimicrobial Drugs for TreatmentJuly 22, 1998DoDo
Secondary Bacterial Infections of Acute Bronchitis; Developing Antimicrobial Drugs for TreatmentJuly 22, 1998DoDo
Streptococcal Pharyngitis and Tonsillitis; Developing Antimicrobial Drugs for TreatmentJuly 22, 1998DoDo
Uncomplicated and Complicated Skin and Skin Structure Infections; Developing Antimicrobial Drugs for TreatmentJuly 22, 1998DoDo
Uncomplicated Gonorrhea—Cervical, Urethral, Rectal, and/or Pharyngeal; Developing Antimicrobial Drugs for TreatmentJuly 22, 1998DoDo
Uncomplicated Urinary Tract Infections; Developing Antimicrobial Drugs for TreatmentJuly 22, 1998DoDo
Vuvlovaginal Candidiasis; Developing Antimicrobial Drugs for TreatmentJuly 22, 1998DoDo
Clinical Development and Labeling of Anti-Infective Drug ProductsOctober 26, 1992Clinical AntimicrobialDo
Clinical Evaluation of Anti-Infective Drugs (Systemic)September 1, 1977DoDo
Start Printed Page 45450
Preclinical Development of Antiviral DrugsNovember 1, 1990DoDo
Abuse Liability AssessmentJuly 1, 1990Clinical Medical DraftDo
Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis (OA)July 15, 1999DoDo
Clinical Evaluation of Anti-Anginal DrugsJanuary 1, 1989DoDo
Clinical Evaluation of Anti-Arrhythmic DrugsJuly 1, 1985DoDo
Clinical Evaluation of Antihypertensive DrugsMay 1, 1988DoDo
Clinical Evaluation of Drugs for the Treatment of Congestive Heart FailureDecember 1, 1987DoDo
Clinical Evaluation of Drugs for Ulcerative Colitis (3rd draft)DoDo
Clinical Evaluation of Lipid-Altering Agents in Adults and ChildrenSeptember 1, 1990DoDo
Clinical Evaluation of Motility-Modifying DrugsDoDo
Clinical Evaluation of Weight-Control DrugsSeptember 24, 1996DoDo
Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the ReviewNovember 22, 1996DoDo
Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the ReviewOctober 13, 1998DoDo
Development and Evaluation of Drugs for the Treatment of Psychoactive Substance Use DisordersFebruary 12, 1992DoDo
Development of Parathyroid Hormone for the Prevention and Treatment of OsteoporosisJune 14, 2000DoDo
Establishing Pregnancy RegistriesJune 4, 1999DoDo
Evaluation of Human Pregnancy Outcome DataJune 4, 1999DoDo
Female Sexual Dysfunction: Clinical Development of Drug Products for TreatmentMay 19, 2000DoDo
In Vivo Pharmacokinetics and Bioavailability Studies and In Vitro Dissolution Testing for Levothyroxine Sodium TabletsJune 10, 1999DoDo
Institutional Review Boards, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency ResearchMarch 30, 2000DoDo
Levothyroxine SodiumAugust 18, 1999DoDo
OTC Treatment of Herpes Labialis with Antiviral AgentsMarch 8, 2000DoDo
Preclinical and Clinical Evaluation of Agents Used in the Prevention or Treatment of Postmenopausal OsteoporosisApril 1, 1994DoDo
Preparation of IND Applications for New Drugs Intended for the Treatment of HIV-Infected IndividualsSeptember 1, 1991DoDo
Start Printed Page 45451
System Inflammatory Response Syndrome (SIRS) 1st DraftDoDo
Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA)February 17, 1999Clinical MedicalDo
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
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 (IND's) for Phase 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 Cell Lung CancerJanuary 21, 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
Start Printed Page 45452
Formatting, Assembling and Submitting New Drug and Antibiotic ApplicationsFebruary 1, 1987DoDo
General Considerations for the Clinical Evaluation of DrugsFebruary 1, 1978DoDo
General Considerations for the Clinical Evaluation of Drugs in Infants and ChildrenSeptember 1, 1977DoDo
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
OTC Treatment of HypercholesterolemiaOctober 27, 1997DoDo
Postmarketing Adverse Experience Reporting for Human Drugs and Licensed Biological Products; Clarification of What to ReportAugust 27, 1997DoDo
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 ProductsNovember 30, 1998Clinical Pharmacology DraftDo
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
Pharmacokinetics in Patients With Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and LabelingDecember 7, 1999DoDo
Population PharmacokineticsFebruary 10, 1999DoDo
Start Printed Page 45453
Investigating Out of Specification (OOS) Test Results for Pharmaceutical ProductionNovember 30, 1998Compliance DraftDo
Manufacture, Processing or Holding of Active Pharmaceutical IngredientsApril 17, 1998DoDo
Repackaging of Solid Oral Dosage Form Drug ProductsFebruary 1, 1992DoDo
A Review of FDA's Implementation of the Drug Export Amendments of 1986ComplianceDo
Compressed Medical GasesFebruary 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
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
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
Regulatory Submissions in Electronic Format; General ConsiderationsJanuary 28, 1999Electronic SubmissionsDo
Regulatory Submissions in Electronic Format; New Drug ApplicationsJanuary 28, 1999DoDo
ANDA's: Blend Uniformity AnalysisAugust 26, 1999Generic Drug DraftDo
ANDA's: Impurities in Drug ProductsJanuary 5, 1999DoDo
Abbreviated New Drug Application (ANDA)—Positron Emission Tomography (PET) Drug Products—With specific information for ANDA's for Fludeoxyglucose F18 InjectionApril 18, 1997DoDo
ANDA's: Impurities in Drug SubstancesDecember 3, 1999Generic DrugDo
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 the CDER & the ORA to clarify the responsibilities of CDER chemistry review scientists and ORA field investigators in the new & abbreviated drug approval process in order to reduce duplication or redundancy in the processOctober 14, 1994DoDo
Start Printed Page 45454
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 December 20, 1984 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
Skin Irritation and Sensitization Testing of Generic Transdermal Drug ProductsFebruary 3, 2000DoDo
Variations in Drug Products that May Be Included in a Single ANDAJanuary 27, 1999DoDo
E10—Choice of Control Group in Clinical TrialsSeptember 24, 1999ICH Draft—EfficacyDo
E11 Clinical Investigation of Medicinal Products in the Pediatric PopulationApril 12, 2000DoDo
M4 Common Technical Document: Request for comments on Initial ComponentsFebruary 11, 2000ICH Draft—Joint Safety/EfficacyDo
Q1A(R) Stability Testing of New Drug Substances and ProductsApril 21, 2000ICH Draft—QualityDo
Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical SubstancesNovember 25, 1997DoDo
Start Printed Page 45455
E1A 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
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
M3 Nonclinical Safety Studies for the Conduct of Human Clinical Trials for PharmaceuticalsNovember 25, 1997ICH—Joint Safety/EfficacyDo
Q1A Stability Testing of New Drug Substances and ProductsSeptember 22, 1994ICH—QualityDo
Q1B Photostability Testing of New Drug Substances and ProductsMay 16, 1997DoDo
Q1C Stability Testing for New Dosage FormsMay 9, 1997DoDo
Q2A Text on Validation of Analytical ProceduresMay 1, 1995DoDo
Q2B Validation of Analytical Procedures: MethodologyMay 19, 1997DoDo
Q3A Impurities in New Drug SubstancesJanuary 4, 1996DoDo
Q3B Impurities in New Drug ProductsMay 19, 1997DoDo
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
Q5C Quality of Biotechnological Products: Stability Testing of Biotechnology/Biological ProductsJuly 10, 1996DoDo
Start Printed Page 45456
Q5D Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological ProductsSeptember 21, 1998DoDo
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 PharmaceuticalsDecember 4, 1997DoDo
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
A Revision in Sample Collection Under the Compliance Program Pertaining to Pre-Approval InspectionsJuly 15, 1996Industry Letterso
Certification Requirements for Debarred Individuals in Drug ApplicationsJuly 27, 1992DoDo
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 programJune 1, 1990DoDo
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 all affected parties about policy developments and interpretations regarding the Act. Three year exclusivity provisions of Title IOctober 31, 1986DoDo
Start Printed Page 45457
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, 1996DoDo
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 FD&CJuly 29, 1988DoDo
Sixth of a series of informal notice letters about the Act discussing 3- and 5-year exclusivity provisions of sections 505(c)(3)(D) and 505(j)(4)(D) of the FD&C ActApril 22, 1988DoDo
Streamlining InitiativesDecember 24, 1996DoDo
Supplement to 10/11/84 letter about policies, procedures and implementation of the Act (Q & A format)November 16, 1984DoDo
Third of a series of letters regarding the implementation of the ActMay 1, 1985DoDo
Content and Format for Geriatric LabelingJanuary 21, 1999Labeling DraftDo
Non-Contraceptive Estrogen Drug Products— Physician and Patient LabelingJanuary 8, 1999DoDo
Noncontraceptive Estrogen Class LabelingSeptember 27, 1999DoDo
OTC Topical Drug Products for the Treatment of Vaginal Yeast Infections (Vulvovaginal Candidiasis)July 16, 1998DoDo
Therapeutic Equivalence Code Placement on Prescription Drug Labels and LabelingJanuary 28, 1999DoDo
Acetaminophen and Codeine Phosphate Oral Solution/SuspensionDecember 1, 1993LabelingDo
Acetaminophen and Codeine Phosphate Tablets/CapsulesDecember 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, 1981DoDo
Butalbital, Acetaminophen and Caffeine Capsules/Tablets USPSeptember 1, 1997DoDo
Butalbital, Acetaminophen, Caffeine and Hydocodone Bitartrate TabletsSeptember 21, 1997DoDo
Butorphanol Tartrate Injection USPOctober 1, 1992DoDo
Start Printed Page 45458
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
Clorazepate Dipotassium Capsules/TabletsMarch 1, 1993DoDo
Combination Oral Contraceptives—Physician and Patient LabelingJanuary 1, 1994DoDo
Cyproheptadine Hydrochloride Tablets/SyrupDecember 1, 1986DoDo
Diclofenac Sodium Delayed-Release TabletsJanuary 1, 1997DoDo
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, 1998DoDo
Ergoloid Mesylates TabletsJanuary 1, 1988DoDo
Fludeoxyglucose F18 InjectionJanuary 1, 1997DoDo
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, 1989DoDo
Hypoglycemic Oral Agents—Federal RegisterApril 1, 1984DoDo
Indomethacin Capsules USPSeptember 1, 1995DoDo
Informal Labeling Guidance Texts for Estrogen Drug Products—Patient LabelingAugust 1, 1992DoDo
Informal Labeling Guidance Texts for Estrogen Drug Products—Professional LabelingAugust 1, 1992DoDo
Isoetharine Inhalation SolutionMarch 1, 1989DoDo
Itraconazole Capsules, USPSeptember 1, 1998DoDo
Leucovorin Calcium for InjectionJuly 1, 1996DoDo
Start Printed Page 45459
Leucovorin Calcium Tablets, USPJuly 1, 1996DoDo
Local Anesthetics—Class LabelingSeptember 1, 1982DoDo
Meclofenamate Sodium CapsulesJuly 1, 1992DoDo
Medroxyprogesterone Acetate Tablets, USPSeptember 1, 1998DoDo
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, 1989DoDo
Naproxen Sodium Tablets, USPSeptember 1, 1997DoDo
Naproxen Tablets, USPSeptember 1, 1997DoDo
Niacin TabletsJuly 1, 1992DoDo
Paclitaxel InjectionFebruary 1, 1991DoDo
Phendimetrazine Tartrate Capsules/Tablets, and Extended-Release CapsulesFebruary 1, 1991DoDo
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, 1995DoDo
Ranitidine Tablets USPNovember 1, 1993DoDo
Risperidone Oral SolutionSeptember 1, 1997DoDo
Risperidone TabletsSeptember 1, 1997DoDo
Sulfacetamide Sodium and Prednisolone Acetate Ophthalmic Suspension and OintmentJanuary 1, 1995DoDo
Sulfacetamide Sodium Ophthalmic Solution/OintmentAugust 1, 1992DoDo
Sulfamethoxazole and Phenazopyridine Hydrochloride TabletsFebruary 1, 1992DoDo
Sulfamethoxazole and Trimethoprim Tablets and Oral SuspensionAugust 1, 1993DoDo
Theophylline Immediate-Release Dosage FormsFebruary 1, 1995DoDo
Theophylline Intravenous Dosage FormsSeptember 1, 1995DoDo
Thiamine Hydrochloride InjectionFebruary 1, 1988DoDo
Tobramycin Sulfate Injection USPMay 1, 1993DoDo
Venlafaxine Hydrochloride TabletsOctober 1, 1997DoDo
Verapamil Hydrochloride TabletsOctober 1, 1991DoDo
Vitamin A CapsulesFebruary 1, 1992DoDo
Start Printed Page 45460
Zolpidem Tartrate TabletsSeptember 1, 1997DoDo
Labeling OTC Human Drug Products Using a Column FormatDecember 1, 1997OTC DraftDo
OTC Actual Use StudiesJuly 22, 1994DoDo
OTC Nicotine SubstitutesMarch 1, 1994DoDo
Enforcement Policy on Marketing OTC Combination Products (CPG 7132b.16)
General Guidelines for OTC Combination ProductsDoDo
Upgrading Category III Antiperspirants to Category I (43 FR 46728-46731)DoDo
Photosafety TestingJanuary 10, 2000Pharmacology/Toxicology DraftDo
Format and Content of the Nonclinical Pharmacology/Toxicology Section of an ApplicationFebruary 1, 1987Pharmacology/ToxicologyDo
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 ContraceptivesDoDo
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)December 8, 1999Procedural DraftDo
Content and Format of New Drug Applications and Abbreviated New Drug Applications for Certain Positron Emission Tomography Drug ProductsMarch 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, 2000December 22, 1999DoDo
Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Establishment of a Data BankMarch 29, 2000DoDo
Information Request and Discipline Review Letters Under the Prescription Drug User Fee ActAugust 17, 1999DoDo
Special Protocol AssessmentFebruary 9, 2000DoDo
Submitting Debarment Certification StatementsOctober 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
Start Printed Page 45461
Court Decisions, ANDA Approvals, and 180-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
Formal Dispute Resolution: Appeals Above the Division LevelMarch 7, 2000DoDo
Formal Meetings With Sponsors and Applicants For PDUFA ProductsMarch 7, 2000DoDo
Implementation of Section 126 of the FDA Modernization Act of 1997—Elimination of Certain Labeling RequirementsJuly 21, 1998DoDo
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
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
Street Drug AlternativesApril 3, 2000DoDo
Women and Minorities Guidance RequirementsJuly 28, 1998DoDo
Information Request and Discipline Review Letters Under the Prescription Drug User Fee ActAugust 17, 1999User Fee DraftDo
Classifying Resubmissions in Response to Action LettersMay 14, 1998User FeeDo
Submitting and Reviewing Complete Responses to Clinical HoldsMay 14, 1998DoDo

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

Name of DocumentDate of IssuanceGrouped by Intended User or Regulatory ActivityHow to Obtain a Hard Copy of the Document (Name and Address, Phone, FAX, E-mail or Internet)
Compliance Program Guidance Manual: Inspection of Medical Devices; DraftAugust 12, 1999Office of Compliance (OC)Division of Small Manufacturers Assistance; 1-800-638-2041 or 301-827-0111 or (FAX) Facts-on-Demand at 1-800-899-0381 or Internet at http://www.fda.gov/​cdrh/​ggpmain.html
Start Printed Page 45462
Procedures for Laboratory Compliance Testing of Television Receivers-part of TV PacketMay 1, 1986DoDo
A Pocket Guide to Device GMP Inspections-Inspections of Medical Device Manufacturers and GMP Regulation RequirementsNovember 1, 1991DoDo
General Principles of Software Validation; Draft GuidanceJune 9, 1997DoDo
Global Harmonization Task Force Study Group 3-Process Validation Guidance; Final DraftFebruary 1, 1999DoDo
Civil Money Penalty Policy; Guidance for FDA StaffJune 8, 1999DoDo
Guidance on Medical Device Tracking; Guidance for Industry and FDA Staff [FDAMA]January 24, 2000DoDo
Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals, Draft Guidance-Not for Implementation; Guidance for Industry and for FDA StaffFebruary 8, 2000DoDo
Cover Letter/Guidance Document on the Performance Standard for Electrode Lead Wires and Patient CableMarch 9, 1998DoDo
Commercial Distribution/Exhibit LetterApril 10, 1992DoDo
Working Draft of the Current Good Manufacturing Practice (CGMP) Final RuleJuly 1, 1995DoDo
Regulating In Vitro Diagnostic Device (IVD) Studies; Guidance; Guidance for FDA StaffDecember 17, 1999Office of Compliance (OC)/Division of Bioresearch Monitoring (DBM)Do
Preparing Notices of Availability of Investigational Medical Devices and for Recruiting Study SubjectsMarch 19, 1999DoDo
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, 1996Office of Compliance (OC)/Division of Enforcement I (DOEI)Do
A Guide for the Submission of Abbreviated Radiation Safety Reports on Image Receptor Support Devices for Mammographic X-Ray SystemsMarch 1, 1996DoDo
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, 1996DoDo
Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (FDA 89-8221)March 1, 1989DoDo
CPG 7133.19: Retention of Microwave Oven Test Record/Cover Letter: August 24, 1981 Retention of Records Required by 21 CFR 1002August 24, 1981DoDo
Start Printed Page 45463
Exemption from Reporting and Recordkeeping Requirements for Certain Sunlamp Product ManufacturersSeptember 16, 1981DoDo
Compliance Program Guidance Manual; Field Compliance Testing of Diagnostic (Medical) X-ray Equipment; Guidance for FDA StaffMarch 15, 2000DoDo
Guidance on Information Disclosure by Manufacturers to Assemblers for Diagnostic X-ray Systems; Guidance for IndustryOctober 18, 1999DoDo
Guidance on Electrosurgical Devices and the Application of the Performance Standard for Electrode Lead Wires and Patient CablesNovember 15, 1999DoDo
Guide for the Submission of Initial Reports on Diagnostic X-Ray Systems and their Major ComponentsJanuary 1, 1982DoDo
Guideline for the Manufacture of In Vitro Diagnostic ProductsJanuary 10, 1994DoDo
Letter to Medical Device Industry on Endoscopy and Laparoscopy Accessories (Galdi)May 17, 1993DoDo
Manufacturers/Assemblers of Diagnostic X-ray Systems: Enforcement Policy for Positive-Beam Limitation (PBL) Requirements in 21 CFR 1020.31(g)October 13, 1993DoDo
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, 1995Office of Compliance (OC)/Division of Enforcement I & III (DOEI & III)Do
Abbreviated Reports on Radiation Safety of Non-Medical Ultrasonic ProductsAugust 1, 1995DoDo
Guide for Filing Annual Reports for X-Ray Components and SystemsJuly 1, 1980DoDo
Guide for Preparing Abbreviated Reports of Microwave and RF Emitting Electronic Products Intended for Medical UseSeptember 1, 1996DoDo
Guide for Preparing Product Reports for Medical Ultrasound ProductsSeptember 1, 1996DoDo
Guide for Preparing Reports on Radiation Safety of Microwave OvensMarch 1, 1985DoDo
Guide for Submission of Information on Accelerators Intended to Emit X-Radiation Required Pursuant to 21 CFR 1002.10April 1, 1971DoDo
Letter to Manufacturers and Importers of Microwave Ovens: Information Requirements for Cookbooks and User and Service ManualsOctober 31, 1988DoDo
Reporting and Compliance Guide for Television Products including Product Report, Supplemental Report, Radiation Safety Abbreviated Report, Annual Report, Information and GuidanceOctober 1, 1995DoDo
Start Printed Page 45464
Reporting Guide for Laser Light Shows and Displays (21 CFR 1002) (FDA 88-8140)September 1, 1995DoDo
Revised Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show Products (replaces FDA 82-8127)September 1, 1995DoDo
All U.S. Condom Manufacturers, Importers and RepackagersApril 7, 1987Office of Compliance (OC)/Division of Enforcement II (DOEII)Do
Compliance Guide for Laser Products (FDA 86-8260)September 1, 1985DoDo
Condoms: Inspection and Sampling at Domestic Manufacturers and of all Repackers; Sampling from all Importers (Damaska Memo to Field on April 8, 1987)April 8, 1987DoDo
Dental Handpiece Sterilization (Dear Doctor Letter)September 28, 1992DoDo
Ethylene Oxide; Ethylene Chlorohydrin; and Ethylene Glycol; Proposed Maximum Residue Limits and Maximum Levels of ExposureJune 23, 1978DoDo
Guidance on Quality System Regulation Information for Various Premarket Submissions; Guidance for Industry; DraftAugust 3, 1999DoDo
Guidance on Quality System Regulation Information for Various Premarket Submissions; Guidance for Industry; DraftAugust 3, 1999DoDo
Guide for Preparing Product Reports for Lasers and Products Containing LasersSeptember 1, 1995DoDo
Hazards of Volume Ventilators and Heated HumidifiersSeptember 15, 1993DoDo
Latex Labeling Letter (Johnson)March 18, 1993DoDo
Letter—Condom Manufacturers and DistributorsApril 5, 1994DoDo
Letter—Manufacturers, Distributors and Importers of Condom ProductsFebruary 23, 1994DoDo
Letter—Manufacturers, Importers, and Repackagers of Condoms for Contraception or Sexually-Transmitted Disease Prevention (Holt)February 13, 1989DoDo
Letter to All Foreign Manufacturers and Importers of Electronic Products for Which Applicable FDA Performance Standards ExistMay 28, 1981DoDo
Letter to Industry, Powered Wheelchair Manufacturers from RMJohnsonMay 10, 1993DoDo
Letter to Manufacturers/Repackers Using CottonApril 22, 1994DoDo
Letter to: Manufacturers and Users of Lasers for Refractive Surgery [excimer]October 10, 1996DoDo
Manufacturers and Initial Distributors of HemodialyzersMay 23, 1996DoDo
Start Printed Page 45465
Manufacturers and Initial Distributors of Sharps Containers and Destroyers Used by Health Care ProfessionalsFebruary 3, 1994DoDo
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, 1994DoDo
Application for a Variance from 21 CFR 1040.11(c) for a Laser Light Show, Display, or Device [form FDA 3147]July 1, 1998Office of Compliance (OC)/Division of Enforcement III (DOEIII)Do
Computerized Devices/Processes Guidance—Application of the Medical Device GMP to Computerized Devices and Manufacturing ProcessesMay 1, 1992DoDo
Design Control Guidance for Medical Device ManufacturersMarch 11, 1997DoDo
Final Design Control Report and GuidanceJune 1, 1998DoDo
Guidance for the Submission of Cabinet X-Ray System Reports Pursuant to 21 CFR 1020.40February 1, 1975DoDo
Guide for Preparing Annual Reports for Ultrasonic Therapy ProductsSeptember 1, 1996DoDo
Guide for Preparing Annual Reports on Radiation Safety Testing of Sunlamps and Sunlamp Products (replaces FDA 82-8127)September 1, 1995DoDo
Guide for Preparing Annual Reports on Radiation Safety Testing of Mercury Vapor Lamps (replaces FDA 82-8127)September 1, 1995DoDo
Guide for Preparing Annual Reports on Radiation Safety Testing of Electronic Products (General)October 1, 1987DoDo
Guide for Preparing Product Reports for Ultrasonic Therapy Products (physical therapy only)August 1, 1996DoDo
Guide for Preparing Product Reports on Sunlamps and Sunlamp Products (21 CFR 1002)September 1, 1995DoDo
Guide for Submission of Information on Analytical X-Ray Equipment Required Pursuant to 21 CFR 1002.10April 30, 1974DoDo
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, 1980DoDo
Guide for Submission of Information on Industrial X-Ray Equipment Required Pursuant to 21 CFR 1002.10March 1, 1973DoDo
Guide for the Submission of Initial Reports on Computed Tomography X-Ray SystemsSeptember 1, 1984DoDo
Start Printed Page 45466
Impact Resistant Lenses: Questions and Answers (FDA 87-4002)September 1, 1987DoDo
Keeping Medical Devices Safe from Electromagnetic InterferenceJuly 1, 1995DoDo
Keeping Up With the Microwave Revolution (FDA Pub No. 91-4160)March 1, 1990DoDo
Laser Light Show Safety—Who's Responsibility (FDA 86-8262)May 1, 1986DoDo
Letter to Manufacturers and Importers of Microwave Ovens—Open Door Operation of Microwave Ovens as a Result of Oven MiswiringMarch 28, 1980DoDo
Letter to Trade Association: ReUse of Single-use or Disposable Medical DevicesDecember 27, 1995DoDo
Letter: Policy on Maximum Timer Interval and Exposure Schedule for Sunlamp ProductsAugust 21, 1986DoDo
Medical Device Electromagnetic Interference Issues, Problem Reports, Standards, and RecommendationsDoDo
Medical Devices and EMI: The FDA PerspectiveJanuary 1, 1995DoDo
Policy on Lamp Compatability (sunlamps)September 2, 1986DoDo
Policy on Warning Label Required on Sunlamp ProductsJune 25, 1985DoDo
Quality Assurance Guidelines for Hemodialysis DevicesFebruary 1, 1991DoDo
Quality Control Guide for Sunlamp Products (FDA 88-8234)March 1, 1988DoDo
Quality Control Practices for Compliance with the Federal Mercury Vapor Lamp Performance StandardMay 1, 1980DoDo
Reporting Guide for Product Reports on High Intensity Mercury Vapor Discharge Lamps (21 CFR 1002)September 1, 1995DoDo
Reporting of New Model Numbers to Existing Model FamiliesJune 14, 1983DoDo
Safety of Electrically Powered Products: Letter To Medical Device and Electronic Product Manufacturers From Lillian Gill & BHB correction memoSeptember 18, 1996DoDo
Shielded Trocars and Needles used for Abdominal Access during LaparoscopyAugust 23, 1996DoDo
Suggested State Regulations for Control of Radiation—Volume II Nonionizing Radiation—Lasers (FDA Pub No. 83-8220)January 1, 1982DoDo
Unsafe Patient Lead Wires and CablesSeptember 3, 1993DoDo
Imports: Radiation-Producing Electronic Products (FDA 89-8008)November 1, 1988DoDo
Start Printed Page 45467
Guidance for Industry on the Likelihood of Facilities Inspections When Modifying Devices Subject to Premarket ApprovalAugust 5, 1999Office of Compliance (OC)/Division of Program Operations (DOP)Do
Letter to Medical Device Manufacturer on Pentium ProcessorsFebruary 14, 1995Office of Compliance (OC)/Office of the Center Director (OCD)Do
Sec. 300.600 Commercial Distribution with Regard to Premarket Notification [510(k)] [CPG 7124.19]September 24, 1987DoDo
Letter to Industry, Powered Wheelchair/Scooter or Accessory/ Component Manufacturer from Susan Alpert, Ph.D.,M.D.May 26, 1994Office of the Center Director (OCD)/Office of Device Evaluation (ODE)Do
General/Specific Intended Use; Guidance for Industry; FinalNovember 4, 1998DoDo
ODE Executive Secretary Guidance ManualAugust 7, 1987DoDo
Preamendments Class III Strategy; SXAlpertApril 19, 1994DoDo
Early Collaboration Meetings Under the FDA Modernization Act (FDAMA), Guidance for Industry and CDRH Staff [FDAMA]February 19, 1998DoDo
“Real-Time” Review Program for Premarket Approval Application (PMA) SupplementsApril 22, 1997Office of Device Evaluation (ODE)Do
30-Day Notices and 135-Day PMA Supplements for Manufacturing Method or Process Changes, Guidance for Industry and CDRH [FDAMA]; FinalFebruary 19, 1998DoDo
510(k) Quality Review Program (Blue Book Memo)March 29, 1996DoDo
Convenience Kits Interim Regulatory Guidance (include 874)May 20, 1997DoDo
Determination of Intended Use for 510(k) Devices Guidance for Industry and CDRH Staff [FDAMA]; FinalJanuary 30, 1998DoDo
Distribution and Public Availability of Premarket Approval Application Summary of Safety and Effectiveness Data Packages [Blue Book Memo #P98-1]; FinalOctober 10, 1997DoDo
Document Review by the Office of the Chief Counsel (Blue Book Memo G96-1))June 6, 1996DoDo
Modifications to Devices Subject to Premarket Approval—The PMA Supplement Decision Making Process; Guidance for Industry, DraftAugust 6, 1998DoDo
Contents of Product Development Protocol; Guidance for Industry, DraftJuly 27, 1998DoDo
Frequently Asked Questions on The New 510(k) Paradigm; Guidance for Industry; FinalOctober 22, 1998DoDo
Start Printed Page 45468
Evidence Models for the Least Burdensome Means to Market; Guidance for Industry and FDA Reviewers; DraftSeptember 1, 1999DoDo
Supplements to Approved Applications for Class III Medical Devices: Use of Published Literature, Use of Previously Submitted Materials, and Priority Review [FDAMA]; Guidance for Industry; FinalMay 20, 1998DoDo
New Model Medical Device Development Process; Guidance for Industry; FinalJuly 21, 1998DoDo
Guidance for Off-the-Shelf Software Use in Medical Devices; FinalSeptember 9, 1999DoDo
Guidance for Submitting Reclassification PetitionJune 1, 1989DoDo
Guidance on Amended Procedures for Advisory Panel Meetings [FDAMA]; FinalJanuary 26, 1999DoDo
Guidance on PMA Interactive Procedures for Day-100 Meetings and Subsequent Deficiencies—For Use by CDRH & Industry [FDAMA]; FinalFebruary 19, 1998DoDo
Guidance on the Use of Standards in Substantial Equivalence Determinations; FinalMarch 12, 2000DoDo
PMA Shell Development and Modular Review; Guidances for the Medical Device Industry; FinalNovember 6, 1998DoDo
New Section 513(f)(2)—Evaluation of Automatic Class III Designation, Guidance for Industry and CDRH Staff [FDAMA]; FinalFebruary 19, 1998DoDo
Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff [FDAMA]; FinalFebruary 19, 1998DoDo
SMDA Changes-Premarket Notification; Regulatory Requirements for Medical Devices [510(k)] Manual InsertApril 17, 1992DoDo
The New 510(k) Paradigm-Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications; FinalMarch 20, 1998DoDo
4-of-A-Kind PMA'sOctober 1, 1991DoDo
Application of the Device Good Manufacturing Practice (GMP) Regulation to the Manufacture of Sterile DevicesDecember 1, 1983DoDo
CDRH Submissions Coversheet [PMA/PDP/510k/IDE]May 8, 1998DoDo
CDRH's 510(k)/IDE/PMA Refuse to Accept/Accept/File PoliciesJune 30, 1993DoDo
Classified Convenience KitsApril 30, 1993DoDo
Color Additive Petitions (p. II-19 of PMA Manual)June 1, 1987DoDo
Color Additive Status List (Inspection Operations Manual)February 1, 1989DoDo
Start Printed Page 45469
Color Additives for Medical Devices (Snesko)November 15, 1995DoDo
Deciding When to Submit a 510(k) for a Change to an Existing DeviceJanuary 10, 1997DoDo
Device Specific Guidance Documents (List)May 11, 1993DoDo
FDA Guide for Validation of Biological Indicator Incubation TimeJanuary 1, 1986DoDo
FDA Policy For The Regulation Of Computer Products (DRAFT)November 13, 1989DoDo
Format for IDE Progress ReportsJune 1996DoDo
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices; Guidance for FDA and Reviewers and Industry; FinalMay 29, 1998DoDo
Guidance for Preparation of PMA Manufacturing InformationAugust 1, 1992DoDo
Guide for Establishing and Maintaining a Calibration Constancy Intercomparison System for Microwave Oven Compliance Survey Instruments (FDA 88-8264)March 1, 1988DoDo
Guideline for the Monitoring of Clinical InvestigationsJanuary 1, 1988DoDo
Guideline on General Principles of Process ValidationMay 1, 1987DoDo
Guideline on Sterile Drug Products Produced by Aseptic ProcessingJune 1, 1987DoDo
Guideline on Validation of the Limulus Amebocyte Lysate (LAL) Test as an End-Product Endotoxin TestDecember 1, 1987DoDo
Indications for Use StatementJanuary 2, 1996DoDo
Industry Representatives on Scientific PanelsMarch 27, 1987DoDo
Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer GuidanceApril 1, 1996DoDo
Limulus Amebocyte Lysate; Reduction of Samples for TestingOctober 23, 1987DoDo
Master Files Part III; Guidance on Scientific and Technical InformationJune 1, 1987DoDo
Electromagnetic Compatibility for Medical Devices: Issues and Solutions; MemorandumJune 13, 1995DoDo
Methods for Conducting Recall Effectiveness ChecksJune 16, 1978DoDo
Necessary Information for Diagnostic Ultrasound 510(k) (Draft)November 24, 1987DoDo
PMA Review Schedule [P87-1]March 31, 1988DoDo
Points to Consider in the Characterization of Cell Lines Used to Produce Biological Products (from John C. Petricciani, M.D.)June 1, 1984DoDo
Start Printed Page 45470
Preamendment Class III DevicesMarch 11, 1992DoDo
Premarket Notification [510(k)] Status Request Form, revisedMarch 14, 1997DoDo
Preproduction Quality Assurance Planning: Recommendations for Medical Device Manufacturers (FDA 90-4236)September 1, 1989DoDo
Proposal for Establishing Mechanisms for Setting Review Priorities Using Risk Assessment and Allocating Review Resources and T93-28 dated June 25, 1993 Device “Fast Track” Plan Announcement (include with 926 930)June 30, 1993DoDo
Questions and Answers for the FDA Reviewer Guidance: Labeling Reusable Medical Devices for Reprocessing in Health Care FacilitiesSeptember 3, 1996DoDo
Shelf Life of Medical DevicesMarch 1, 1991DoDo
Substantial Equivalence (SE) Decision Making Documentation ATTACHED: “SE” Decision Making Process (Detailed), i.e., the decision making treeJanuary 1, 1990DoDo
Suggested Content for Original IDE Application Cover Letter—Version 4February 27, 1996DoDo
Suggestions for Submitting a Premarket Approval (PMA) ApplicationApril 1, 1993DoDo
Threshold Assessment of the Impact of Requirements for Submission of PMA's for 31 Medical Devices Marketed Prior to May 28, 1976January 1, 1990DoDo
Interagency Agreement between FDA & HCFA; #D95-2, Attachment ASeptember 15, 1995Office of Device Evaluation (ODE)/BlueBookDo
Criteria for Categorization of Investigational Devices (HCFA); #D95-2, Attachment BSeptember 15, 1995DoDo
Deciding When to Submit a 510(k) for a Change to an Exisiting Device; Blue Book Memo #K97-1January 10, 1997DoDo
510(k) Additional Information Procedures #K93-1 (Blue Book Memo)July 23, 1993DoDo
510(k) Refuse to Accept Procedures #K94-1 (Blue Book Memo)May 20, 1994DoDo
510(k) Sign-Off Procedures #K94-2 (Blue Book Memo)June 3, 1994DoDo
510(k) Sterility Review Guidance and Revision of November18/1994 #K90-1 (Blue Book Memo)February 12, 1990DoDo
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, 1995DoDo
Assignment of Review Documents #I90-2 (Blue Book Memo)August 24, 1990DoDo
Start Printed Page 45471
Center for Devices and Radiological Health's Investigational Device Exemption (IDE) Refuse to Accept PolicyJune 30, 1993DoDo
Center for Devices and Radiological Health's Premarket Notification [510(k)] Refuse to Accept Policy—(updated Checklist March 14, 1995)June 30, 1993DoDo
Clinical Utility and Premarket Approval #P91-1 (Blue Book Memo)May 3, 1991DoDo
Consolidated Review of Submissions for Diagnostic Ultrasound Equipment, Accessories and Related Measurement Devices #G90-2 (Blue Book Memo)October 19, 1990DoDo
Consolidated Review of Submissions for Lasers and Accessories #G90-1 (Blue Book Memo)October 19, 1990DoDo
Continued Access to Investigational Devices During PMA Preparation and Review (Blue Book Memo)July 15, 1996DoDo
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, 1995DoDo
Criteria for Panel Review of PMA Supplements #P86-3 (Blue Book Memo)January 30, 1986DoDo
Delegation of IDE Actions #D88-1 (Blue Book Memo)April 26, 1988DoDo
Device Labeling Guidance #G91-1 (Blue Book Memo)March 8, 1991DoDo
Document Review Processing #I91-1 (Blue Book Memo)February 12, 1992DoDo
Documentation and Resolution of Differences of Opinion on Product Evaluations #G93-1 (Blue Book Memo)December 23, 1993DoDo
Executive Secretaries Guidance Manual #G87-3August 7, 1987DoDo
Goals and Initiatives for the IDE Program #D95-1 (Blue Book Memo)July 12, 1995DoDo
Guidance on the Center for Devices and Radiological Health's Premarket Notification Review Program #K86-3 (Blue Book Memo)June 30, 1986DoDo
HCFA Reimbursement Categorization Determinations for FDA-approved IDEsOctober 31, 1995DoDo
IDE Refuse to Accept Procedures #D94-1 (Blue Book Memo)May 20, 1994DoDo
Integrity of Data and Information Submitted to ODE #I91-2 (Blue Book Memo)May 29, 1991DoDo
Meetings with the Regulated Industry #I89-3 (Blue Book Memo)November 20, 1989DoDo
Start Printed Page 45472
Memorandum of Understanding Regarding Patient Labeling Review (Blue Book Memo #G96-3))August 9, 1996DoDo
Nondisclosure of Financially Sensitive Information #I92-1 (Blue Book Memo)March 5, 1992DoDo
ODE Regulatory Information for the Office of Compliance—Information Sharing Procedures #G87-2 (Blue Book Memo)May 15, 1987DoDo
Overdue IDE Annual Progress Report Procedures #D93-1 (Blue Book Memo)July 23, 1993DoDo
Panel Report and Recommendations on PMA Approvals #P86-5 (Blue Book Memo)April 18, 1986DoDo
Panel Review of “Me-Too” Devices #P86-6 (Blue Book Memo)July 1, 1986DoDo
Panel Review of Premarket Approval Applications #P91-2 (Blue Book Memo)May 3, 1991DoDo
PMA Compliance Program #P91-3 (Blue Book Memo)May 3, 1991DoDo
PMA Filing Decisions #P90-2 (Blue Book Memo)May 18, 1990DoDo
PMA Refuse to File Procedures #P94-1 (Blue Book Memo)May 20, 1994DoDo
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, 1990DoDo
PMA/510(k) Triage Review Procedures #G94-1 (Blue Book Memo)May 20, 1994DoDo
PMA's—Early Review and Preparation of Summaries of Safety and Effectiveness #P86-1 (Blue Book Memo)January 27, 1986DoDo
Policy Development and Review Procedures #I90-1 (Blue Book Memo)February 15, 1990DoDo
Premarket Approval Application (PMA) Closure #P94-1 (Blue Book Memo)July 8, 1994DoDo
Premarket Notification—Consistency of Reviews #K89-1 (Blue Book Memo)February 28, 1989DoDo
Review and Approval of PMA's of Licensees #P86-4 (Blue Book Memo)October 22, 1990DoDo
Review of 510(k)s for Computer Controlled Medical Devices #K91-1 (Blue Book Memo)August 29, 1991DoDo
Review of Final Draft Medical Device Labeling #P91-4 (Blue Book Memo)August 29, 1991DoDo
Review of IDEs for Feasibility Studies #D89-1 (Blue Book Memo)May 17, 1989DoDo
Review of Laser Submissions #G88-1 (Blue Book Memo)April 15, 1988DoDo
Start Printed Page 45473
Telephone Communications Between ODE Staff and Manufacturers #I93-1 (Blue Book Memo)January 29, 1993DoDo
Toxicology Risk Assessment Committee #G89-1 (Blue Book Memo)August 9, 1989DoDo
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, 1995DoDo
Points to Consider for Portable Blood Glucose Monitoring Devices Intended for Bedside Use in the Neonate NurseryFebruary 20, 1996Office of Device Evaluation (ODE)/Division of Clinical Laboratory Devices (DCLD)Do
Letter to IVD Manufacturers on Streamlined PMA; FinalDecember 22, 1997
Assessing the Safety/Effectiveness of Home-use In Vitro Diagnostic Devices (IVD's): Points to Consider Regarding Labeling and Premarket Submissions; DraftOctober 1, 1988DoDo
Data for Commercialization of Original Equipment Manufacturer, Secondary and Generic Reagents for Automated AnalyzersJune 10, 1996DoDo
Criteria for Assessment of In Vitro Diagnostic Devices for Drugs of Abuse Assays Using Various Methodologies; DraftAugust 31, 1995DoDo
Guidance Document for 510(k) Submission of Fecal Occult Blood Tests; DraftJuly 29, 1992DoDo
Guidance Document for 510(k) Submission of Glycohemoglobin (Glycated or Glycosylated) Hemoglobin for IVDs; DraftSeptember 30, 1991DoDo
Guidance Document for 510(k) Submission of Immunoglobulins A, G, M, D and E Immunoglobulin System In Vitro Devices; DraftSeptember 1, 1992DoDo
Guidance for 510(k) Submission of Lymphocyte Immunophenotyping IVDs using Monoclonal Antibodies; DraftSeptember 26, 1991DoDo
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, 1999DoDo
Review Criteria for Nucleic Acid Amplification Based In Vitro Diagnostic Devices for Direct Detection of Infectious Microorganisms; DraftJune 14, 1993DoDo
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, 1992DoDo
Guidance Criteria for Cyclosporine PMA'sJanuary 24, 1992DoDo
Start Printed Page 45474
Guidance Document for the Submission of Tumor Associated Antigen Premarket Notification [510(k)] to FDASeptember 19, 1996DoDo
Guidance for 510(k)s on Cholesterol Tests for Clinical Laboratory, Physicians' Office Laboratory, and Home UseJuly 14, 1995DoDo
Guidance for Industry—Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators; FinalFebruary 22, 1999DoDo
Document for Special Controls for Erythropoietin Assay Premarket Notifications [510(k)s] Guidance for Industry; FinalApril 28, 1999DoDo
Guidance for Premarket Submissions for Kits for Screening Drugs of Abuse to Be Used By The Consumer; Guidance for Industry; DraftDecember 30, 1998DoDo
Guidance on Labeling for Laboratory Tests; Guidance for Industry; DraftJune 24, 1999DoDo
In Vitro Diagnostic Bicarbonate/Carbon Dioxide Test System; Guidance for Industry; FinalJuly 6, 1998DoDo
In Vitro Diagnostic Chloride Test System; Guidance for Industry; FinalJuly 6, 1998DoDo
In Vitro Diagnostic C-Reactive Protein Immunological Test System; Guidance for Industry; FinalJuly 20, 1998DoDo
In Vitro Diagnostic Creatinine Test System; Guidance for Industry; FinalJuly 2, 1998DoDo
In Vitro Diagnostic Glucose Test System; Guidance for Industry ; FinalJuly 6, 1998DoDo
Guidance for Industry—In Vitro Diagnostic Potassium Test System; FinalJuly 6, 1998DoDo
In Vitro Diagnostic Sodium Test System; Guidance for Industry; FinalJuly 6, 1998DoDo
In Vitro Diagnostic Urea Nitrogen Test System; Guidance for Industry; FinalJuly 6, 1998DoDo
Points to Consider Guidance Document on Assayed and Unassayed Quality Control Material; Guidance for Industry;February 3, 1999DoDo
In Vitro Diagnostic Fibrin Monomer Paracoagulation Test; Guidance for Industry and FDA Reviewers/Staff; FinalApril 27, 1999DoDo
Guidance for Labeling for Over-the-Counter Sample Collection Systems for Drugs of Abuse Testing; DraftDecember 21, 1999DoDo
Guidance for Submission of Immunohistochemistry Applications to the FDAJune 3, 1998DoDo
Points to Consider for Cervical Cytology DevicesJuly 25, 1994DoDo
Points to Consider for Collection of Data in Support of In-Vitro Device Submissions for 510(k) ClearanceSeptember 26, 1994DoDo
Start Printed Page 45475
Points to Consider for Hematology Quality Control MaterialsSeptember 30, 1997DoDo
Points to Consider for Review of Calibration and Quality Control Labeling for In Vitro Diagnostic Devices/Cover Letter dated March 14/1996February 1, 1996DoDo
Review Criteria for Assessment of Alpha-Fetoprotein (AFP) in vitro Diagnostic Devices for Fetal Open Neural Tube Defects Using Immunological Test MethodologiesJuly 15, 1994DoDo
Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices; DraftMarch 8, 2000DoDo
Review Criteria for Assessment of Antimicrobial Susceptibility Test DiscsOctober 30, 1996DoDo
Review Criteria for Assessment of Cytogenetic Analysis Using Automated and Semi-Automated Chromosome AnalyzersJuly 15, 1991DoDo
Review Criteria for Assessment of Human Chorionic Gonadotropin (hCG) In Vitro Diagnostic Devices (IVDs)September 27, 1995DoDo
Review Criteria for Assessment of In Vitro Diagnostic Devices for Direct Detection of Mycobacterium Spp. Tuberculosis [(TB)]July 6, 1993DoDo
Review Criteria for Assessment of In Vitro Diagnostic Devices for Direct Detection of Chlamydiae in Clinical SpecimensJanuary 1, 1992DoDo
Review Criteria for Assessment of Laboratory Tests for the Detection of Antibodies to Helicobacter pyloriSeptember 17, 1992DoDo
Review Criteria for Assessment of Portable Blood Glucose In Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase, or Hexokinase MethodologyFebruary 14, 1996DoDo
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, 1997DoDo
Review Criteria for Blood Culture SystemsAugust 12, 1991DoDo
Review Criteria for Devices Assisting in the Diagnosis of C. Difficile Associated DiseasesMay 31, 1990DoDo
Review Criteria for Devices Intended for the Detection of Hepatitis B “e” Antigen and Antibody to HbeDecember 30, 1991DoDo
Review Criteria for In Vitro Diagnostic Devices for Detection of IGM Antibodies to Viral AgentsAugust 1, 1992DoDo
Start Printed Page 45476
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, 1994DoDo
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, 1996DoDo
Review Criteria For Premarket Approval of In Vitro Diagnostic Devices for Detection of Antibodies to Parvovirus B19May 15, 1992DoDo
Review Criteria for the Assessment of Allergen-Specific Immunoglobulin E (IGE) In-Vitro Diagnostic Devices Using Immunological Test MethodologiesMarch 2, 1993DoDo
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, 1992DoDo
Guidance for Industry and FDA; Guidance for Indwelling Blood Gas Analyzer 510(k) SubmissionsFebruary 21, 2000Office of Device Evaluation (ODE)/Division of Cardiovascular, Respiratory & Neurological Devices (DCRND)Do
Balloon Valvuloplasty Guidance For The Submission Of an IDE Application and a PMA ApplicationJanuary 1, 1989DoDo
Battery GuidanceJuly 12, 1993DoDo
Carotid Stent—Suggestions for Content of Submissions to the Food and Drug Administration in Support of Investigational Devices Exemption (IDE) ApplicationsOctober 26, 1996DoDo
Coronary and Cerebrovascular Guidewire GuidanceJanuary 1, 1995DoDo
510(K) Submission Requirements for Peak Flow Meters; DraftJanuary 13, 1994DoDo
Emergency Resuscitator Guidance; DraftApril 14, 1993DoDo
Guidance for Implantable Cardioverter-Defibrillators; DraftJune 24, 1996DoDo
Guidance for the Preparation of Research and Marketing Applications for Vascular Graft Prostheses; DraftAugust 1, 1993DoDo
Guidance for the Submission of Research and Marketing Applications for Interventional Cardiology Devices: PTCA Catheters, Atherectomy Catheters, Lasers, Intravascular Stents; DraftMay 1, 1995DoDo
Guidance: Human Heart Valve Allografts; DraftJune 21, 1991DoDo
Start Printed Page 45477
Intravascular Brachytherapy—Guidance for Data to be Submitted to the Food and Drug Administration in Support of Investigational Device Exemption (IDE) Applications; DraftMay 24, 1996DoDo
Percutaneous Transluminal Coronary Angioplasty Package Insert Template; DraftFebruary 7, 1995DoDo
Replacement Heart Valve Guidance; DraftOctober 14, 1994DoDo
Reviewer Guidance for Ventilators; DraftJuly 1, 1995DoDo
Reviewer Guidance on Face Masks and Shield for CPR; DraftMarch 16, 1994DoDo
Cardiac Ablation Preliminary Guidance (Data to be Submitted to the FDA in Support Investigation Device Exemption Application; DraftMarch 1, 1995DoDo
Electrode Recording Catheter Preliminary Guidance (Data to be Submitted to the FDA in Support of Premarket Notifications [510(k)s]) ; DraftMarch 1, 1995DoDo
Excerpts Related to EMI from November 1993 Anesthesiology and Respiratory Devices Branch/EMC Standard for Medical Devices (to be used with EMI Standard)November 1, 1993DoDo
General Guidance Document: Non-Invasive Pulse OximeterSeptember 7, 1992DoDo
Guidance Document: Electrocardiograph (ECG) Surface Electrode Tester—Version 1.0February 11, 1997DoDo
Guidance Document for Premarket Notification Submission for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer; FinalJanuary 24, 2000DoDo
Guidance Document for Vascular Prostheses 510(k) Submission; FinalNovember 26, 1999DoDo
Guidance for Annuloplasty Rings 510(k) Submissions; FinalNovember 26, 1999DoDo
Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions; FinalFebruary 21, 2000DoDo
Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions; FinalJanuary 17, 2000DoDo
Guidance for Cardiovascular Intravascular Filter 510(k) Submission; FinalNovember 26, 1999DoDo
Guidance for Extracorporeal Blood Circuit Defoamer 510(k) Submissions; FinalFebruary 16, 2000DoDo
Cardiac Monitor Guidance (including Cardiotachometer and Rate Alarm); Guidance for Industry; FinalNovember 5, 1998DoDo
Diagnostic ECG Guidance (Including Non-Alarming ST Segment Measurement); Guidance for Industry; FinalNovember 5, 1998DoDo
Start Printed Page 45478
Recommended Clinical Study Design for Ventricular Tachycardia Ablation; Guidance for Industry and for FDA ReviewersMay 7, 1999DoDo
Guidance for Oxygen Conserving Device 510(k) Review 73 BZD 868.5905 Non-continuous Ventilator Class IIFebruary 1, 1989DoDo
Guidance for Peak Flow Meters for Over-the-Counter SaleJune 23, 1992DoDo
Guidance for the Preparation of the Annual Report to the PMA Approved Heart Valve ProsthesesApril 1, 1990DoDo
Guidance for the Submission of 510(k) Premarket Notifications for Electrocardiograph (ECG) Electrode Version 1.0February 11, 1997DoDo
Guidance for the Submission of 510(k) Premarket Notifications for Electrocardiograph (ECG) Lead Switching Adapter Version 1.0February 11, 1997DoDo
Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions; FinalJanuary 14, 2000DoDo
Heated Humidifier Review GuidanceAugust 30, 1991DoDo
Implantable Pacemaker Testing GuidanceJanuary 12, 1990DoDo
Vascular Graft Manufacturer, Developer, or Representative; Letter/GuidanceMay 11, 1990DoDo
Medical Device Labeling—Suggested Format and Content; Draft DocumentApril 25, 1997DoDo
Non-Invasive Blood Pressure (NIBP) Monitor GuidanceMarch 10, 1997DoDo
Policy for Expiration Dating (DCRND RB92-G)October 30, 1992DoDo
Review Guidelines for Oxygen Generators and Oxygen Equipment; Draft DocumentApril 14, 1993DoDo
Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and ActuatorsOctober 1, 1993DoDo
Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and ActuatorsNovember 9, 1990DoDo
Reviewer's Guidance for Oxygen ConcentratorAugust 30, 1991DoDo
Guidance for Conducting Stability Testing to Support an Expiration Date Labeling Claim for Medical Gloves; DraftNovember 16, 1999Office of Device Evaluation (ODE)/Division of Dental,  Infection Control and General Hospital Devices (DDIGD)Do
Devices for the Treatment and/or Diagnosis of Temporomandibular Joint Dysfunction and/or Orofacial Pain; FinalJune 10, 1998DoDo
Guidance on the Content and Format of Premarket Notification [510(k)] Submission of Washers and Washer-Disinfectors; DraftNovember 5, 1998DoDo
Start Printed Page 45479
Guidance Document for Washers and Washer-Disinfectors Intended for Processing Reusable Medical DevicesJune 2, 1998DoDo
Overview of Information Necessary for Premarket Notification Submissions for Endoseous Implants; FinalApril 21, 1999DoDo
Reprocessing and Reuse of Single-Use Devices: Review Prioritization Scheme; DraftFebruary 8, 2000DoDo
Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities; AddendumSeptember 19, 1995DoDo
Guidance Document for the Preparation of Premarket Notification [510(k)'S] for Dental Alloys; DraftMarch 3, 1997DoDo
Supplementary Guidance on the Content of Premarket Notification [510(k)] Submissions for Medical Devices with Sharps Injury Prevention Features (Antistick); DraftMarch 1, 1995DoDo
Guidance and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants; FinalJanuary 3, 2000DoDo
Guidance Document on Dental HandpiecesJuly 1, 1995DoDo
Premarket Notification [510(k)] Submissions for Testing for Skin Sensitization to Chemicals in Natural Latex Products; Guidance for Industry and FDA Reviewers/Staff; FinalJanuary 13, 1999DoDo
Testing for Sensitizing Chemicals in Natural Rubber Latex Medical Devices; (Addendum to Premarket Notification [510(k) Submissions for Testing for Skin Sensitization to Chemicals in Natural Latex Products; Guidance for Industry and FDA Reviewers/Staff; Final)July 27, 1997
Neonatal and Neonatal Transport Incubators-Premarket Notifications; Guidance for Industry and FDA Reviewers; FinalSeptember 18, 1998DoDo
Dental Cements Premarket Notification; FinalAugust 18, 1998DoDo
Guidance For The Arrangement and Content of a Premarket Approval (PMA) Application For An Endosseous Implant For Prosthetic AttachmentMay 16, 1989DoDo
Guidance for the Preparation of a Premarket Notification [510(k)] for Direct Filling Dental CompositesNovember 27, 1998DoDo
Guidance for the Preparation of Premarket Notification [510(k)] for Resorbable Periodontal BarriersApril 1991DoDo
Guidance on 510(k) Submissions for Implanted Infusion PortsOctober 1, 1990DoDo
Start Printed Page 45480
Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care FacilitiesAugust 1, 1993DoDo
Guidance on Premarket Notification [510(K)] Submissions for Short-Term and Long-Term Intravascular CathetersMarch 16, 1995DoDo
Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care FacilitiesMarch 1, 1993DoDo
Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical DrapesAugust 1, 1993DoDo
Guidance on the Content and Format of Premarket Notification [510(k)] for Testing for Skin Sensitization to Chemicals in Latex Products [Draize Testing]February 13, 1998DoDo
Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Sharps ContainersOctober 1, 1993DoDo
Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for General Purpose Disinfectants (includes Addendum of March 9, 1994)October 1, 1993DoDo
Guidance on the Content and Format of Premarket Notification 510(k) Submissions for Liquid Chemical GermicidesDecember 6, 1996DoDo
Guidance on the Content of Premarket Notification [510(k)] Submissions for Protective RestraintsDecember 1, 1995DoDo
Guidance on the Content of Premarket Notification [510(K)] Submissions for Hypodermic Single Lumen NeedlesApril 1, 1993DoDo
Guidance on the Content of Premarket Notification [510(K)] Submissions for Piston SyringesApril 1, 1993DoDo
Guidance on the Content of Premarket Notification [510(K)] Submissions for Clinical Electronic ThermometersMarch 1, 1993DoDo
Guidance on the Content of Premarket Notification [510(k)] Submissions for External Infusion PumpsMarch 1, 1993DoDo
Dental Impression Materials Premarket Notification; FinalAugust 17, 1998DoDo
OTC Denture Cushions, Pads, Reliners, Repair Kits and Partially Fabricated Denture Kits; FinalAugust 18, 1998DoDo
Information Necessary for Premarket Notification Submissions For Screw-Type Endossesous ImplantsDecember 9, 1996DoDo
510(k) Information Needed for Hydroxyapatite Coated Orthopedic ImplantsFebruary 20, 1997Office of Device Evaluation (ODE)/Division of General & Restorative Devices (DGRD)Do
Start Printed Page 45481
Alternate Suture Labeling Resulting From the January 11, 1993 Meeting with HIMA (Reformatted December 17, 1997)January 11, 1993DoDo
Calcium Phosphate (Ca-P) Coating Draft Guidance for Preparation of FDA Submissions for Orthopedic and Dental Endosseous ImplantsFebruary 21, 1997DoDo
Copy of October 9, 1992 Letter and Original Suture Labeling Guidance (Reformatted December 17, 1997)October 9, 1992DoDo
510(k) Guideline for General Surgical Electrosurgical Devices; DraftMay 10, 1995DoDo
Data Requirements for Ultrahigh Molecular Weight Polyethylene (Uhmupe) Used in Orthopedic Devices; DraftMarch 28, 1995DoDo
Guidance Document for Femoral Stem Prostheses; DraftAugust 1, 1995DoDo
Guidance Document for Testing Acetabular Cup Prostheses; DraftMay 1, 1995DoDo
Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Orthopedic Devices-The Basic Elements; DraftJuly 16, 1997DoDo
Guidance for Arthroscopes and Accessory 510(k)s; DraftMay 1, 1994DoDo
Guidance for Testing MR Interaction with Aneurysm Clips; DraftMay 22, 1996DoDo
Guidance for the Preparation of a Premarket Notification for a Non-Interactive Wound and Burn Dressing [510(k)] ; DraftMay 31, 1995DoDo
Guidance for the Preparation of a Premarket Notification for Extended Laparoscopy Devices (ELD); DraftAugust 30, 1994DoDo
Guidance for the Preparation of an IDE Submission for a Interactive Wound and Burn Dressing; DraftApril 4, 1995DoDo
Guidance for the Preparation of Premarket Notifications [510(k)] s for Cemented, Semi-Constrained Total Knee Prostheses; DraftApril 1, 1993DoDo
Outline for a Guidance Document for Testing Orthopedic Bone Cement, request for comments by December 10, 1993; DraftNovember 1, 1993DoDo
Premarket Notification Review Guidance for Evoked Response Somatosensory Stimulators; DraftJune 1, 1994DoDo
Guidance on Biocompatibility Requirements for Long Term Neurological Implants: Part-3 Implant Model; DraftSeptember 12, 1994DoDo
Biofeedback Devices—Guidance for 510(k) Content; DraftAugust 1, 1994DoDo
Cranial Perforator Guidance; DraftJuly 13, 1994DoDo
Start Printed Page 45482
Guidance for Clinical Data to be Submitted for Premarket Approval Application for Cranial Electrotherapy Stimulators; DraftAugust 20, 1992DoDo
Guide for Cortical Electrode 510(k) Content; DraftAugust 10, 1992DoDo
Neuro Endoscope Guidance; DraftJuly 7, 1994DoDo
Electroencephalograph Devices Guidance for 510(k) Content; DraftNovember 3, 1997DoDo
Galvanic Skin Response Measurement Devices-Draft Guidance for 510(k) ContentAugust 1, 1994DoDo
Guidance Document for the Preparation of IDEs for Spinal Systems; FinalJanuary 13, 2000DoDo
Preparation of Investigational Device Exemptions and Premarket Approval Applications for Bone Growth Stimulator Devices; Guidance Document for Industry and CDRH Staff; DraftMarch 18, 1998DoDo
Guidance Document for Surgical Lamp 510Ks; FinalJuly 13, 1998DoDo
Guidance Document for Testing Biodegradable Polymer Implant Devices; DraftApril 20, 1996DoDo
Guidance Document for Testing Bone Anchor Devices; DraftApril 20, 1996DoDo
Guidance Document for Testing Non-Articulating, “Mechanically Locked”, Modular Implant Components; DraftMay 1, 1995DoDo
Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement (replaces 8623 and 8093)April 28, 1994DoDo
Guidance Document for the Preparation of IDE and PMA Applications for Intra-Articular Prosthetic Knee Ligament DevicesFebruary 18, 1993DoDo
Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Submerged (Underwater) Exercise EquipmentJuly 26, 1995DoDo
Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Electromyograph Needle ElectrodesJuly 26, 1995DoDo
Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Exercise EquipmentJuly 26, 1995DoDo
Guidance Document for the Preparation of Premarket Notification [510k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled VehiclesJuly 26, 1995DoDo
Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for BedsJuly 26, 1995DoDo
Start Printed Page 45483
Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Immersion HydrobathsJuly 26, 1995DoDo
Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Powered Tables and Multifunctional Physical Therapy TablesJuly 26, 1995DoDo
Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Communications Systems (Powered and Non-Powered) and Powered Environmental Control SystemsJuly 26, 1995DoDo
Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Therapeutic Massagers and VibratorsJuly 26, 1995DoDo
Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and Cooling DevicesJuly 26, 1995DoDo
Guidance Document For The Preparation of Premarket Notification For Ceramic Ball Hip SystemsJanuary 10, 1995DoDo
Guidance Document for Dura Substitute Devices; FinalAugust 13, 1999DoDo
Guidance Document for Neurological Embolization Devices; Guidance for Industry; FinalAugust 13, 1999DoDo
Guidance for the Preparation of a Premarket Notification Application for Processed Human Dura Mater; Guidance for Industry; FinalAugust 30, 1999DoDo
Guidance for Dermabrasion Devices; FinalMarch 2, 1999DoDo
Guidance on Preclinical and Clinical Data and Labeling for Breast Prostheses; Guidance for Industry; DraftOctober 5, 1999DoDo
Guidance for Spinal System 510(k)s; FinalMay 7, 1999DoDo
Guidance Document for Powered Suction Pump 510(k)s; Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance; FinalOctober 30, 1998DoDo
Guidance Document for Powered Muscle Stimulator 510(k)s; Guidance for Industry, FDA Reviewers/Staff and Compliance; FinalJune 9, 1999DoDo
Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses; Guidance for Industry; FinalApril 28, 1998DoDo
Guidance for Studies for Pain Therapy Devices—General Considerations in the Design of Clinical Studies for Pain-Alleviating DevicesMay 12, 1988DoDo
Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh; FinalMarch 2, 1999DoDo
Start Printed Page 45484
Guidance on the Content and Organization of a Premarket Notification for a Medical LaserJune 1, 1995DoDo
Guide for TENS 510(k) Content; DraftAugust 1, 1994DoDo
Guidelines for Reviewing Premarket Notifications that Claim Substantial Equivalence to Evoked Response StimulatorsFebruary 1997DoDo
Core Study for Silicone Breast Implants; LetterJanuary 11, 1996DoDo
ORDB 510(k) Sterility Review GuidanceJuly 3, 1997DoDo
Protocol for Dermal Toxicity Testing for Devices in Contact with Skin; DraftJanuary 1985DoDo
Reviewers Guidance Checklist for Intramedullary RodsFebruary 21, 1997DoDo
Reviewers Guidance Checklist for Orthopedic External Fixation DevicesFebruary 21, 1997DoDo
Premarket Notification [510(k)] Guidance Document for Class II Daily Wear Contact Lenses; Amendment 1; DraftJune 28, 1994Office of Device Evaluation (ODE)/Division of Ophthalmic Devices (DOD)Do
Guidance for Premarket Submission of Orthokeratology Rigid Gas Permeable Contact Lenses; FinalApril 10, 2000DoDo
An FDA Survey of U.S. Contact Lens Wearers (Carol L. Herman) Reprinted from Contact Lens SpectrumJuly 1, 1987DoDo
Announcement by Dr. Alpert at July 26, 1996 Ophthalmic Panel Meeting concerning Manufacturers & Users of Lasers for Refractive Surgery [Excimer]August 26, 1996DoDo
Announcement: Information for Manufacturers & Users of Lasers for Refractive Surgery [Excimer]September 22, 1997DoDo
Checklist of Information Usually Submitted in an Investigational Device Exemptions (IDE) Application for Refractive Surgery Lasers [Excimer]October 10, 1996DoDo
Contact Lenses: The Better the Care the Safer the Wear; Publication No. FDA 91-4220April 1, 1991DoDo
Discussion Points for Expansion of the “Checklist of Information Usually Submitted in an Investigational Device Exemption (IDE) Application for Refractive Surgery Lasers”; DraftSeptember 5, 1997DoDo
Premarket Notification [510(k)] Guidance Document for Class II Daily Wear Contact Lenses and June 28, 1994 corrections to pages 18 & 20; DraftMay 12, 1994DoDo
Premarket Notification 510(k) Guidance for Contact Lens Care Products; DraftMay 1, 1997DoDo
Facts for Consumers from the Federal Trade Commission-EyeglassesApril 1, 1986DoDo
Start Printed Page 45485
FDA Guidelines for Multifocal Intraocular Lens IDE Studies and PMA'sMay 29, 1997DoDo
Ophthalmoscope Guidance (Direct and Indirect); Guidance for IndustryJuly 8, 1998DoDo
Guidance Document for Nonprescription Sunglasses; FinalOctober 9, 1998DoDo
Retinoscope Guidance; FinalJuly 8, 1998DoDo
Slit Lamp Guidance; FinalJuly 13, 1998DoDo
Revised Procedures for Adding Lens Finishing Laboratories to Approved Premarket Approval (PMA) Applications for Class III Rigid Gas Permeable Contact Lenses for Extended Wear; Guidance for Industry and FDA Staff; FinalAugust 11, 1998DoDo
Accountability Analysis for Clinical Studies for Ophthalmic Devices; DraftAugust 4, 1999DoDo
Aqueous Shunts—510(k) Submissions; FinalNovember 16, 1998DoDo
Guidance on 510(k) Submissions for Keratoprostheses; FinalMarch 3, 1999DoDo
Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Surgical Mask; DraftJanuary 16, 1998DoDo
Important Information About Rophae Intraocular LensesAugust 20, 1992DoDo
Intraocular Lens (IOL) Guidance Document; DraftOctober 14, 1999DoDo
New FDA Recommendations & Results of Contact Lens Study (7 Day Letter)May 30, 1989DoDo
Owners Certification of Lasers as PMA Approved Devices Excimer]September 26, 1996DoDo
Third Party Review Guidance for Vitreous Aspiration and Cutting Device Premarket Notification [510(k)]January 31, 1997DoDo
Update on Excimer Lasers for NearsightednessMay 20, 1996DoDo
Guidance for Manufacturers Seeking Marketing Clearance of Ear, Nose, and Throat Endoscope Sheaths Used as Protective Barriers; FinalMarch 12, 2000DoDo
510(k) Checklist for Sterile Lubricating Jelly Used With Transurethral Surgical InstrumentsSeptember 19, 1994Office of Device Evaluation (ODE)/Division of Reproductive, Abdominal, ENT & Radiological Devices (DRAERD)Do
Guidance for Hemodialyzer Reuse Labeling; DraftNovember 6, 1995DoDo
Content of Premarket Notification for Hemodialysis Delivery Systems; Guidance for Industry and CDRH Reviewers; FinalAugust 7, 1998DoDo
Start Printed Page 45486
Guidance for the Content of Premarket Notifications (510(k)s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral CalculiFebruary 8, 1999Do
CDRH Interim Regulatory Policy for External Penile Rigidity DevicesSeptember 10, 1997DoDo
Checklist for Mechanical Lithotripters and Stone Dislodgers used in Gastroenterology and UrologyNovember 1, 1994DoDo
510(k) Checklist for Conditioned Response Enuresis Alarms; DraftNovember 23, 1994DoDo
510(k) Checklist for Condom Catheters; DraftFebruary 23, 1995DoDo
510(k) Checklist for Endoscopic Electrosurgical Unit (ESU) and Accessories Used in Gastroenterology and Urology; DraftAugust 16, 1995DoDo
510(k) Checklist for Endoscopic Light Sources Used in Gastroenterology and Urology; DraftJune 22, 1995DoDo
510(k) Checklist for Non-Implanted Electrical Stimulators Used for the Treatment of Urinary Incontinence; DraftJune 6, 1995DoDo
510(k) Checklist for Urological Irrigation System and Tubing Set; DraftAugust 1, 1995DoDo
Guidance for Clinical Investigations of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH); DraftNovember 11, 1994DoDo
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; DraftFebruary 5, 1992DoDo
Guidance for Preclinical and Clinical Investigations of Urethral Bulking Agents Used in the Treatment of Urinary Incontinence; DraftNovember 29, 1995DoDo
Guidance for Preparation of PMA Applications for Penile Inflatable Implants; DraftMarch 16, 1993DoDo
Guidance for Preparation of PMA Applications for Testicular Prostheses; DraftMarch 16, 1993DoDo
Guidance for Preparation of PMA Applications for the Implanted Mechanical/Hydraulic Urinary Continence Device (Artificial Urinary Sphincter); DraftMay 1, 1995DoDo
Guidance for Review of Bone Densitometer 510(k) Submissions; DraftNovember 9, 1992DoDo
Guidance for the Clinical Investigation of Urethral Stents; DraftNovember 2, 1995DoDo
Guidance for the Content of Premarket Notifications for Endoscopes used in Gastroenterology and Urology; DraftMarch 17, 1995DoDo
Start Printed Page 45487
Guidance for the Content of Premarket Notifications for Loop and Rollerball Electrodes for GYN Electrosurgical Excisions; DraftJuly 29, 1991DoDo
Guidance for the Content of Premarket Notifications for Menstrual Tampons; DraftMay 25, 1995DoDo
Guidance for the Content of Premarket Notifications for Urological Balloon Dilatation Catheters; DraftJanuary 24, 1992DoDo
Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis; DraftMay 30, 1997DoDo
Guidance Outline-Points to Consider for Clinical Studies for Vasovasostomy Devices; DraftNovember 30, 1993DoDo
Guidance to Firms on Biliary Lithotripsy Studies; DraftAugust 2, 1990DoDo
Suggested Information for Reporting Extracorporeal Shock Wave Lithotripsy Device Shock Wave Measurements; DraftJanuary 18, 1991DoDo
Thermal Endometrial Ablation Devices (Submission Guidance for an IDE); DraftMarch 14, 1996DoDo
Devices Used for In Vitro Fertilization and Related Assisted Reproduction Procedures: Submission Guidance for a 510(k); Draft AvailabilitySeptember 10, 1998DoDo
Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters; Guidance for Industry; FinalNovember 30, 1998DoDo
Guidance (“Guidelines”) for Evaluation of Fetal Clip ElectrodeMarch 8, 1977DoDo
Guidance (“Guidelines”) for Evaluation of Hysteroscopic Sterilization DevicesMay 10, 1978DoDo
Guidance (“Guidelines”) for Evaluation of Laparoscopic Bipolar and Thermal Coagulators (and Accessories)May 1978DoDo
Guidance (“Guidelines”) for Evaluation of Tubal Occlusion DevicesNovember 22, 1977DoDo
Guidance for the Submission of Premarket Notifications for Emission Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems; Guidance for Industry; FinalDecember 3, 1998DoDo
Guidance for the Submission of Premarket Notifications for Radionuclide Dose Calibrators; Guidance for Industry; FinalNovember 20, 1998DoDo
Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices; Guidance for Industry; FinalNovember 14, 1998DoDo
Start Printed Page 45488
Harmonic Imaging With/Without Contrast Premarket Notification; Guidance for Industry; FinalNovember 16, 1998DoDo
Non-Automated Sphygmomanometer (Blood Pressure Cuff) Guidance; Version 1; Guidance for Industry; FinalNovember 19, 1998DoDo
Uniform Contraceptive Labeling; Guidance for Industry; FinalJuly 23, 1998DoDo
Guidance for the Content of Premarket Notifications for Penile Rigidity Implants; FinalJanuary 16, 2000DoDo
Electro-optical Sensors for the In Vivo Detection of Cervical Cancer and its Precursors: Submission Guidance for an IDE/PMA; Guidance for Industry; DraftAugust 25, 1999DoDo
Noise Claims in Hearing Aid Labeling; FinalOctober 21, 1998DoDo
Guidance for Magnetic Resonance Diagnostic Devices—Criteria for Significant Risk InvestigationsSeptember 29, 1997DoDo
Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery; DraftDecember 16, 1999DoDo
Guidance for the Arrangement and Content of a Premarket Approval (PMA) Application for a Cochlear Implant in Children Ages 2 through 17 YearsMay 1, 1990DoDo
Guidance for the Comment and Review of 510(k) Notifications for Picture Archiving and Communications Systems (PACS) and Related DevicesAugust 1, 1993DoDo
Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and UrologyFebruary 10, 1993DoDo
Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley CathetersSeptember 12, 1994DoDo
Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents; FinalFebruary 5, 1998DoDo
Guidance for the Content of Premarket Notifications for Urethral StentsFebruary 10, 1993DoDo
Guidance for the Content of Premarket Notifications for Urine Drainage BagsJune 7, 1994DoDo
Guidance for the Content of Premarket Notifications for Urodynamic/Uroflowmetry SystemsJuly 29, 1994DoDo
Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices; FinalAugust 6, 1999DoDo
Guidance for the Technical Content of a Premarket Approval (PMA) Application for an Endolymphatic Shunt Tube with ValveApril 1, 1990DoDo
Start Printed Page 45489
Guidance for the Content of Premarket Notifications for Conventional and Permeability Hemodialyzers; Guidance to Industry and CDRH Reviewers; FinalAugust 7, 1998DoDo
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, 1990DoDo
Guidelines for Evaluation of Non-Drug IUD'sSeptember 28, 1976DoDo
Home Uterine Activity Monitors: Guidance for the Submission of 510(k) Premarket Notifications; DraftJuly 30, 1999DoDo
Hysteroscopes and Gynecology Laparoscopes—Submission Guidance for a 510(k) includes 00192March 27, 1996DoDo
Hysteroscopic and Laparoscopic Insufflators: Submission Guidance for a 510(k)August 1, 1995DoDo
Information for a Latex Condom 510(k) Submission for Obstetrics-Gynecology Devices Branch; DraftJuly 1, 1997DoDo
Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers; DraftSeptember 30, 1997DoDo
Intrapartum Continuous Monitors for Fetal Oxygen Saturation and Fetal pH; Submission Guidance for a PMA; DraftJune 14, 1997DoDo
Latex Condoms for Men-Information for 510(k) Premarket Notifications: Use of Consensus Standards for Abbreviated SubmissionsJuly 23, 1998DoDo
Notice to Manufacturers of Bone Mineral Densitometers; LetterSeptember 25, 1997DoDo
Premarket Testing Guidelines for FalloposcopesNovember 20, 1992DoDo
Premarket Testing Guidelines for Female Barrier Contraceptive Devices Also Intended to Prevent Sexually Transmitted DiseasesApril 4, 1990DoDo
Reviewer Guidance for Automatic X-Ray Film Processor 510(k)February 1, 1990DoDo
Simplified 510(k) Procedures For Certain Radiology Devices (December 21, 1993 letter from L Yin, ODE/DRAERD, to NEMA)December 21, 1993DoDo
Information for Manufacturers Seeking Marketing Clearance of Digital Mammography Systems; Status UpdateJune 19, 1996DoDo
Testing Guidance for Male Condoms Made from New Material (Non-Latex)June 29, 1995DoDo
Tympanostomy Tubes Submission Guidance for a 510(k) Premarket Notification; FinalJanuary 14, 1998DoDo
Start Printed Page 45490
Guidance on Amended Procedures for Advisory Panel Meetings [FDAMA] FinalMarch 20, 1998ODE/Program Operations Staff (POS)Do
PMA/510(k) Expedited Review-Guidance for Industry and CDRH Staff [FDAMA] FinalMarch 20, 1998DoDo
PMA/510(k) Expedited Review #G98-4 (Blue Book Memo)March 20, 1998DoDo
Guidance on IDE Policies and Procedures [FDAMA]; FinalJanuary 20, 1998DoDo
FDA Modernization Act of 1997 Guidance for the Device Industry on Implementation of Highest Priority Provisions [FDAMA]; FinalFebruary 6, 1998Office of Health and Industry Programs (OHIP)Do
Overview of FDA Modernization Act of 1997 Medical Device Provisions [FDAMA]; FinalJune 5, 1998DoDo
Guidance: The Mammography Quality Standards Act Final Regulations Document #1; FinalMarch 4, 1999Office of Health and Industry Programs (OHIP)/Division of Mammography Quality and Radiation Programs (DMQRP)Do
Guidance: The Mammography Quality Standards Act Final Regulations Document #2; FinalFebruary 25, 2000DoDo
Guidance: The Mammography Quality Standards Act Final Regulations Document #3; DraftDecember 8, 1999DoDo
Guidance The Mammography Quality Standards Act Final Regulations—Mammography Facility Survey and Medical Physicist Qualification Requirements Under MQSA; FinalMay 5, 1999DoDo
Guidance The Mammography Quality Standards Act Final Regulations—Preparing for MQSA Inspections; FinalMay 5, 1999DoDo
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); FinalMay 4, 1999DoDo
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); FinalMarch 26, 1998DoDo
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); FinalMarch 26, 1998DoDo
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); FinalMarch 26, 1998DoDo
Start Printed Page 45491
Accidental Radioactive Contamination of Human Food and Animal Feeds: Recommendations for State and Local Agencies; FinalAugust 13, 1998DoDo
Guidance for Policy and Standard Operating Procedures When Mammography Facilities in States that Have Accreditation Bodies Intend to Change Accreditation Bodies; FinalApril 15, 1998DoDo
Guidance: The Mammography Quality Standards Act Final Regulations Preparing for MQSA Inspections; FinalMay 5, 1999DoDo
Guidance: The Mammography Quality Standards Act Final Regulations Motion of Tube-Image Receptor Assembly; FinalMarch 23, 1999DoDo
Guidance: The Mammography Quality Standards Act Final Regulations: Quality Assurance Documentation; FinalDecember 7, 1999DoDo
Premarket Notification: 510(k)-Regulatory Requirements for Medical Devices (FDA 95-4158) [available on disk]August 1, 1995Office of Health and Industry Programs (OHIP)/Division of Small Manufacturers Assistance (DSMA)Do
Labeling-Regulatory Requirements for Medical Devices (FDA 89-4203)September 1, 1989DoDo
Classification Names for Medical Devices and In Vitro Diagnostic Products (FDA Pub No. 95-4246)March 1, 1995DoDo
An Introduction to Medical Device Regulations (FDA 92-4222)January 1, 1992DoDo
Comparison Chart: 1996 Quality System Reg vs. 1978 Good Manufacturing Practices Reg vs. ANSI/ISO/ASQC Q9001 and ISO/DI 13485:1996November 11, 1996DoDo
Medical Glove Guidance Manual; FDA 99-4257; DraftAugust 30, 1999DoDo
In Vitro Diagnostic Devices: Guidance for the Preparation of 510(k) Submissions (FDA 97-4224) [available on disk]January 1, 1997DoDo
Instructions for Completion of Medical Device Registration and Listing Forms FDA 2891, 2891a and 2892July 1, 1997DoDo
Investigational Device Exemptions [IDE] Manual (FDA 96-4159) [available on disk]June 1, 1996DoDo
Medical Device Appeals and Complaints: A Guidance on Dispute Resolution; FinalFebruary 19, 1998DoDo
Medical Device Reporting for Manufacturers [available on disk]March 1, 1997DoDo
Premarket Approval (PMA) Manual; FinalJanuary 1, 1998DoDo
Regulatory Requirements for Devices for the Handicapped (FDA 87-4221)August 1, 1987DoDo
Small Business Guide to FDA (FDA 96-1092)January 1, 1996DoDo
Start Printed Page 45492
The FDA Export Reform and Enhancement Act of 1996/Export Certification Package including “Instructions for Requests for Certificate to Foreign Governments”; FinalFebruary 7, 2000DoDo
U.S.-FDA-Regulation of Medical Devices; Background Information for International Officials (entire document available on disk); FinalApril 14, 1999DoDo
510(k) Manual-Premarket Notification: 510(k)-Regulatory Requirements for Medical DevicesAugust 1, 1995DoDo
Export—Foreign Liaison (part of “Exporting Medical Devices,” February 25, 1999)December 2, 1998DoDo
Exporting Medical Devices; FinalFebruary 25, 1999DoDo
Third Party Programs Under the Sectoral Annex on Medical Devices to the Agreement on Mutual Recognition Between the United States of America and the European Community (MRA); Guidance for Staff, Industry, and Third Parties; FinalJanuary 6, 1999DoDo
Implementation of Third Party Programs Under the FDA Modernization Act of 1997; Guidance for Staff, Industry, and Third Parties; FinalOctober 30, 1998DoDo
Medical Device Quality Systems Manual: A Small Entity Compliance GuideDecember 1, 1996DoDo
Do It By Design—An Introduction to Human Factors in Medical DevicesDecember 1, 1996Office of Health and Industry Programs (OHIP)/Division of Device User Programs and Systems Analysis (DUPSA)Do
Guidance on Medical Device Patient Labeling; Guidance for Industry; DraftMarch 3, 2000Do  DUPSADo
Device Use Safety: Incorporating Human Factors in Risk Management; Guidance For Industry and FDA Premarket and Postmarket Review Staff; DraftAugust 3, 1999Do  DUPSADo
Human Factors Points to Consider for IDE Devices; DraftJanuary 17, 1997Do  DUPSADo
Human Factors Principles for Medical Device LabelingSeptember 1, 1993Do  DUPSADo
Medical Device Reporting for User FacilitiesApril 1, 1996Do  DUPSADo
Write it Right; Recommendations for Developing User Instruction Manuals for medical Devices Used in Home Health CareAugust 1, 1993DoDo
Perspectives on Clinical Studies for Medical Device Submissions (Statistical)Unknown Pre-1997Office of Surveillance and Biometrics (OSB)/Do
PMA Review Statistical ChecklistUnknown Pre-1997DoDo
Statistical Aspects of Submissions to FDA: A Medical Device Perspective (also includes an Appendix the article “Observed Uses and Abuses of Statistical Procedures in Medical Device Submissions”June 1, 1984Office of Surveillance and Biometrics (OSB)/Division of Biostatistics (DB)Do
Start Printed Page 45493
Amendment to Guidance on Discretionary Postmarket Surveillance on Pacemaker Leads; FinalMarch 30, 1994Office of Surveillance and Biometrics (OSB)/Issues Management Staff (IMS)Do
Guidance on Procedures for Review of Postmarket Surveillance Submissions [FDAMA]; FinalFebruary 19, 1998DoDo
Guidance on Procedures to Determine Application of Postmarket Surveillance Strategies [FDAMA]; FinalFebruary 19, 1998DoDo
SMDA to FDAMA: Guidance on FDA's Transition Plan for Existing Postmarket Surveillance Protocols [FDAMA]; Guidance for Industry and FDA Staff; FinalNovember 2, 1998DoDo
Guidance to Sponsors on the Development of a Discretionary Postmarket Surveillance Study for Permanent Implantable Cardiac Pacemaker Electrodes (Leads); FinalJune 9, 1993DoDo
Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements; Guidance for Industry; FinalFebruary 2, 2000Office of Surveillance and Biometrics (OSB)/Division of Postmarket Surveillance (DPS)Do
Common Problems: Baseline Reports and Medwatch Form 3500AJanuary 1997Office of Surveillance and Biometrics (OSB)/Division of Surveillance Systems (DSS)Do
Instructions for Completing FDA Form 3500A with Coding Manual for Form 3500A (MEDWATCH) (MDR)December 15, 1995DoDo
MDR Documents Access Information for National Technical Information Service (NTIS)May 10, 1996DoDo
MDR Internet List Server (listserv) Instruction sheetAugust 29, 1996DoDo
MEDWATCH FDA Form 3500A For Use By User Facilities, Distributors and Manufacturers for Mandatory Reporting (MDR)June 1, 1993DoDo
MDR Reporting Guidance For Breast Implants—E1996002August 7, 1996DoDo
Addendum to the Instructions for Completing FDA Form 3500A with Coding Manual (MEDWATCH) (MDR)June 9, 1999DoDo
Instructions for Completing Form 3417: Medical Device Reporting Baseline Report MDR]March 31, 1997DoDo
Summary Reporting Approval for Adverse Events; Letter to Manufacturers; FinalJuly 31, 1997DoDo
MDR Guidance Document No. 1—IOL—E1996004August 7, 1996DoDo
MDR Guidance Document No. 3-Needlestick & Blood Exposure—E1996003August 9, 1996DoDo
MDR Guidance Document: Remedial Action Exemption—E1996001July 30, 1996DoDo
Start Printed Page 45494
MDR Reporting Guidance for Date-Related Problems Including Y2KApril 16, 1999DoDo
Medical Device Reporting: An Overview; FinalApril 1, 1996DoDo
Variance from Manufacturer Report Number Format [MDR letter]; FinalJuly 16, 1996DoDo
A Primer on Medical Device Interactions with Magnetic Resonance Imaging Systems; DraftFebruary 7, 1997Office of Science and Technology (OST)Do
Frequently Asked Questions on Recognition of Consensus Standards [FDAMA]; FinalDecember 21, 1998DoDo
Viable Bacteriophage in CO2 Laser Plume: Aerodynamic Size DistributionUnknown pre-1997DoDo
Guidance on the Recognition and Use of Consensus Standards/Appendix A [FDAMA]; FinalFebruary 19, 1998DoDo
CDRH Standard Operating Procedures for the Identification and Evaluation of Candidate Consensus Standard for Recognition; FinalAugust 6, 1999DoDo
Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices), Guidance for FDA Reviewers and Industry; FinalNovember 16, 1998DoDo
Guidance on FDA's Expectations of Medical Device Manufacturers Concerning the Year 2000 Date Problems; FinalMay 15, 1998DoDo
Guidance on Immunotoxicity Testing; FinalMay 6, 1999Office of Science and Technology (OST)/Division of Life Sciences (DLS)Do

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

Name of DocumentDate of IssuanceGrouped by Intended 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, PB96-920500
Compliance Programs Guidance Manual1995FDA Regulated IndustriesNational Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, 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, PB-95-913399
Start Printed Page 45495
Regulatory Procedures ManualAugust 1995FDA Regulated IndustriesNational Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, 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, PB96-920500
Pesticides Analytical Manual1994Food IndustryNational Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, 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 & Dairy Foods & 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, 1992 (57 FR 22984)Developers 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
Appendix I—Model Small Business Food Labeling Exemption NoticeJune 1996Food IndustryDo
Food Labeling: Questions and AnswersAugust 1994Food IndustryDo
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, 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
Start Printed Page 45496
Fabrication of Single Service Containers and Closures for Milk and Milk Products1995StatesMilk Safety Branch (HFS-626), Center for Food Safety and Applied Nutrition, 200 C St. SW., Washington, DC 20202, 202-205-9175
Evaluation of Milk Laboratories1995StatesDo
Methods of Making Sanitation Ratings Of Milk Supplies1995StatesDo
Dry Milk Ordinance1995StatesDo
Procedures Governing the Cooperative State-Public Health Service/Food and Drug Administration Program for Certification of Interstate Milk Shippers1995Dairy 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 Ordinance1995StatesMilk Safety Branch (HFS-626), Center for Food Safety and Applied Nutrition 200 C St. SW., Washington, DC 20204, 202-205-9175
FDA Nutrition Labeling Manual: A Guide for Developing and Using Databases1993Food IndustryOffice of Nutritional Products, Labeling, and Dietary Supplements, Food and Drug Administration (HFS-800), 200 C St. SW., Washington, DC 20204, 202-205-4561
Guidelines for Determining Metric Equivalents of Household MeasuresOctober 1, 1993Food IndustryDo
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 CPG's)1995Food and AnimalDo
1997 FDA Food Code1997StatesNational 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, Office of Seafood (HFS-407), Shellfish Sanitation Branch, 200 C St. SW., Washington, DC 20204, 202-418-3150
Fish and Fisheries Products Hazards and Controls Guide1996Seafood IndustryDo
Start Printed Page 45497
Guidance for Submitting Requests under 21 CFR 170.39, Threshold of Regulation for Substances Used in Food Articles1996Food Packaging Industry,Office 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
Guidelines 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 AdditivesDo
Environmental Assessment Technical HandbookMarch 1987Petitioners for Food or Color AdditivesNational Technical Inion Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, Pub. No. PB87175345-AS, Ab-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 AdditivesOffice of Premarket Approval, Food and Drug Administration (HFS-200), 200 C St. SW., Washington, DC 20204, 202-418-3100
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, 1997 (62 FR 8248)Food IndustryDo
Start Printed Page 45498
Guidelines Concerning Notification and Testing of Infant Formula1985Infant 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 New Infant Formulas for Feeding Infants with Allergic Diseases1988Infant 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
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 Vegetables1998Farmers and Food PackersLou Carson, Food Safety Initiative (HFS-3), FDA-CFSAN, 200 C St. SW., Washington, DC 20204 or jsaltsman@bangate.fda.gov
Start Printed Page 45499
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), FDA-CFSAN, 200 C. St. SW., Washington, DC 20204
Partial List of Enzyme Preparations That are Used in Foods1998FDA Regulated IndustryDo
Partial List of Microorganisms and Microbial-Derived Ingredients That Are Used in Food1998FDA Regulated IndustryOffice of Premarket Approval (HFS-200), FDA-CFSAN, 200 C St. SW., Washington, DC 20204
Fish and Fishery Products Hazards and Controls Guide, 2nd EditionJanuary 1998FDA Regulated IndustryOffice of Seafood (HFS-400), FDA-CFSAN, 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), 200 C St. SW., Washington, DC 20204
Small Business Juice Labeling: Questions and Answers1998Small BusinessOffice of Nutritional Products, Labeling, and Dietary Supplements (HFS-150), 200 C St. SW., Washington, DC 20204, Geraldine June, 202-205-5099
FDA Nutrition Labeling Manual, A Guide for Developing and Using Data BasesMarch 1998FDA Regulated IndustryOffice of Nutritional Products, Labeling, and Dietary Supplements (HFS-150), 200 C St. SW., Washington, DC 20204
HACCP Regulation for Fish and Fishery Products: Questions and Answers, Issue Three, Revised January 1999January 1999Seafood ProcessorsOffice of Seafood, CFSAN/FDA (HFS-400), 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), 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
Draft Guidance: Channels of Trade Policy for Commodities with Methyl Parathion ResiduesJune 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
Start Printed Page 45500
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 Industry,Office 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
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
Seafood HACCP Transition PolicyDecember 1999Regulated IndustryOffice of Seafood (HFS-400), 200 C St. SW., Washington DC 20204, 202-205-3150

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

Name of DocumentDate of IssuanceGrouped by Intended User or Regulatory ActivityHow to Obtain a Hard Copy of the Document (Name and Address, Phone, FAX, E-mail or Internet)
Guideline 3—General Principles for Evaluating the Safety of Compounds Used in Food-Producing AnimalsJuly 1994Animal Drug IndustryInternet via: http://www.fda.gov/​cvm or Communications Staff (HFV-12), FDA/CVM, 7500 Standish Pl., Rockville, MD 20855, 301-594-1755, FAX 301-594-1831
Guideline 4—Guidelines for Efficacy Studies for Systemic Sustained Release Sulfonamide Boluses for CattleDoDo
Start Printed Page 45501
Guideline 5—Stability GuidelinesDecember 1990DoDo
Guideline 6—Guidelines for Submitting NADA's for Generic Drugs Reviewed by NAS/NRCDoDo
Guideline 9—Preclearance Guidelines for Production DrugsOctober 1975DoDo
Guideline 10—Amendment of Section II (G)(1)(b)(4) of the Preclearance GuidelinesOctober 1975DoDo
Guideline 13—Guidelines for Evaluation of Effectiveness of New Animal Drugs for Use in Free-Choice FeedsJanuary 1985DoDo
Guideline 14—Guideline and Format for Reporting the Details of Clinical Trials Using An Investigational New Animal Drug in FOOD Producing AnimalsDoDo
Guideline 15—Guideline and Format for Reporting the Details of Clinical Trials Using An Investigational New Animal Drug in Non-Food Producing AnimalsFebruary 1977DoDo
Guideline 16—FOI Summary GuidelineMay 1985DoDo
Guideline 18—Antibacterial Drugs in Animal Feeds: Human Health Safety CriteriaDoDo
Guideline 19—Antibacterial Drugs in Animal Feeds: Animal Health Safety CriteriaDoDo
Guideline 20—Antibacterial Drugs in Animal Feeds: Antibacterial Effectiveness CriteriaDoDo
Guideline 22—Guideline Labeling of Arecoline Base Drugs Intended for Animal UseDoDo
Guideline 23—Medicated Free Choice Feeds—Manufacturing ControlJuly 1985DoDo
Guideline 24—Guidelines for Drug Combinations for Use in AnimalsOctober 1983DoDo
Guideline 25—Guidelines for the Efficacy Evaluation of Equine AnthelminticsJanuary 1979DoDo
Guideline 29—Guidelines for the Effectiveness Evaluation of Swine AnthelminticsSeptember 1980DoDo
Guideline 31— Guidelines for the Evaluation of Bovine AnthelminticsJuly 1981DoDo
Guideline 33—Target Animal Safety Guidelines for New Animal DrugsJune 1989DoDo
Guideline 35—Bioequivalence Guideline—Final1996DoDo
Guideline 36—Guidelines for Efficacy Evaluation of Canine/Feline AnthelminticsJuly 1985DoDo
Guideline 37—Guidelines for Evaluation of Effectiveness of New Animal Drugs for Use in Poultry Feed for PigmentationMarch 1984DoDo
Guideline 38—Guideline for Effectiveness Evaluation of Topical/Otic Animal DrugsAugust 1984DoDo
Guideline 40—Draft Guideline for the Evaluation of the Efficacy of Anticoccidial Drugs and Anticoccidial Drug Combinations in PoultryApril 1992DoDo
Start Printed Page 45502
Guideline 41—Draft Guideline: Formatting, Assembling, and Submitting New Animal Drug ApplicationsJune 1992DoDo
Guideline 42—Animal Drug Manufacturing Guidelines, 19941994DoDo
Guideline 43—Guidance on Generic Animal Drug Products Containing Fermentation-Derived Drug SubstancesOctober 1995DoDo
Guideline 45—Guideline for Uniform Labeling of Drugs for Dairy and Beef CattleAugust 1993DoDo
Guideline 48—Guidance for Industry for the Submission of Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug ProductsNovember 1994DoDo
Guideline 49—Guidance Document for Target Animal Safety and Drug Effectiveness Studies for Anti-Microbial Bovine Mastitis ProductsApril 1996DoDo
Guideline 50—Draft Guideline for Target Animal and Human Food Safety, Drug Efficacy, Environmental and Manufacturing Studies for Teat Antiseptic ProductsFebruary 1993DoDo
Guideline 52—Guidance—Microbiological Testing of Antimicrobial Drug Residues in FoodJanuary 1996DoDo
Guideline 53—Guideline for the Evaluation of the Utility of Food Additives in Diets Fed to Aquatic AnimalsMay 1994DoDo
Guideline 54—Draft Guideline for Utility Studies for Anti-Salmonella Chemical Food Additives in Animal FeedsJune 1994DoDo
Guideline 55—Supportive Data for Cat Food Labels Bearing “Reduces Urinary pH Claims: Guideline in Protocol Development”June 1994DoDo
Guideline 56—Protocol Development Guideline for Clinical Effectiveness and Target Animal Safety TrialsNovember 1994DoDo
Guideline 57—Master Files—Guidance for Industry for the Preparation and Submission of Veterinary Master FilesJuly 1995DoDo
Guideline 58—Guidance for Industry for Good Target Animal Study Practices: Clinical Investigators and MonitorsMay 1997DoDo
Guideline 59—Guidance for Industry: Submitting a Notice of Claimed Investigational Exemption in Electronic Format to CVM via E-MailJanuary 1999DoDo
Guidance 61—Guidance for Industry—FDA Approval of Animal Drugs for Minor Uses and for Minor SpeciesJanuary 1999DoDo
Guideline 62—Guidance for Industry—Consumer-Directed Broadcast AdvertisementsAugust 1997DoDo
Guideline 63—Guidance for Industry—Validation of Analytical Procedures: Definition and Terminology—Draft GuidanceDecember 1997DoDo
Start Printed Page 45503
Guideline 64—Guidance for Industry—Validation of Analytical Procedures: Methodology—Draft GuidanceDecember 1997DoDo
Guideline 65—Guidance for Industry—Industry-Supported Scientific and Educational ActivitiesNovember 1997DoDo
Guideline 66—Guidance for Industry— Professional Flexible Labeling of Antimicrobial Drugs—Draft GuidanceJanuary 1998DoDo
Guideline 67—Guidance for Industry—Small Entities Compliance Guide for RenderersFebruary 1998DoDo
Guideline 68—Guidance for Industry—Small Entities Compliance Guide for Protein Blenders, Feed Manufacturers, and DistributorsFebruary 1998DoDo
Guideline 69—Guidance for Industry—Small Entities Compliance Guide for Feeders of Ruminant Animals With On-Farm Feed Mixing OperationsFebruary 1998DoDo
Guideline 70—Guidance for Industry—Small Entities Compliance Guide for Feeders of Ruminant Animals Without On-Farm Feed Mixing OperationsFebruary 1998DoDo
Guideline 71—Guidance for Industry—Use of Human Chorionic Gonadotropic (HCG) as a Spawning Aid for FishApril 1998DoDo
Guideline 72—Guidance for Industry—GMP's for Medicated Feed Manufacturers Not Required to Register and Be Licensed With FDAMay 1998DoDo
Guideline 73—Draft Guidance for Industry—Stability Testing of New Animal Drug Substances and ProductsJuly 1998DoDo
Guideline 74—Draft Guidance for Industry—Stability Testing for New Dosage Forms of New Animal DrugsJuly 1998DoDo
Guideline 75—Guidance for Industry—Stability Testing: Photostability Testing of New Animal Drug Substances and Products: Draft GuidanceJuly 1998DoDo
Guideline 76—Guidance for Industry—Questions and Answers—BSE Feed RegulationSeptember 1998DoDo
Guideline 77—Guidance for Industry—Interpretation of On-Farm Feed Manufacturing and Mixing Operations—Draft GuidanceSeptember 1998DoDo
Guideline 78—Guidance for Industry—Evaluation of the Human Health Impact of the Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in Food-Producing AnimalsDecember 1999DoDo
Guidance for Industry: Chemistry, Manufacturing and Controls Changes to an Approved NADA or ANADA: Draft GuidanceJune 1999DoDo
Draft Guidance for Industry: Good Clinical PracticesJuly 1999DoDo
Start Printed Page 45504
Guidance for Industry: Efficacy of Anthelmintics: General Recommendations: Draft GuidanceJuly 1999DoDo
Guidance for Industry: Stability Testing for Medicated Premixes Draft GuidanceJuly 1999DoDo
Guidance for Industry: Impurities in New Veterinary Drug Substances Draft GuidanceJuly 1999DoDo
Guidance for Industry: Impurities in New Veterinary Medical Products Draft GuidanceJuly 1999DoDo
Guidance for Industry: Efficacy of Anthelmintics: Specific Recommendations for Bovines: Draft GuidanceJuly 1999DoDo
Guidance for Industry: Efficacy of Anthelmintics: Specific Recommendations for Ovines: Draft GuidanceJuly 1999DoDo
Guidance for Industry—Validation of Analytical Procedures: Definition and TerminologyJuly 1999DoDo
Guidance for Industry—Validation of Analytical Procedures: Methodology: Final GuidanceJuly 1999DoDo
Guidance for Industry: Efficacy of Anthelmintics: Specific Recommendations for Caprines: Draft GuidanceJuly 1999DoDo
Guidance for Industry: Manufacture and Distribution of Unapproved Piperazine ProductsAugust 1999DoDo
Guidance for Industry: Possible Dioxin/PCB Contamination of Drug and Biological ProductsAugust 1999DoDo
Guidance for Industry—Consumer-Directed Broadcast Advertisements: Final GuidanceAugust 1999DoDo
Guidance for Industry: Stability Testing of New Veterinary Dosage Forms VICH GL4: Final GuidanceSeptember 1999DoDo
Guidance for Industry: Stability Testing of New Veterinary Drug Substances and Medicinal Products VICH GL3: Final GuidanceSeptember 1999DoDo
Guidance for Industry: Environmental Impact Assessments (EIA's) for Veterinary Medicinal Products (VMP's)—Phase I: Draft GuidanceSeptember 1999DoDo
Guidance for Industry: Quality of Biotechnological Products in the Veterinary Field: Stability Testing of Biotechnological/Biological Products VICH GL 17: Draft GuidanceSeptember 1999DoDo
Guidance for Industry: Impurities: Residual Solvents VICH GL 18: Draft GuidanceSeptember 1999DoDo
Guidance for Industry—Content and Format of Effectiveness and Target Animal Safety Technical Sections and Final Study Reports for Submission to the Division of Therapeutic Drugs for Non-Food AnimalsSeptember 1999DoDo
Guidance for Industry: Stability Testing: Photostability Testing of New Veterinary Drug Substances and Medicinal Products: Final GuidanceSeptember 1999DoDo
Start Printed Page 45505
Computerized Systems Used in Clinical TrialsOctober 1999DoDo
Dioxin in Anti-Caking Agents Used in Animal Feed and Feed IngredientsOctober 1999DoDo
Guidance for Industry—Evaluation of the Human Health Impact of the Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in Food-Producing AnimalsDecember 1999DoDo
Guidance for Industry: Development of Supplemental Applications for Approved New Animal Drugs—Draft GuidanceJanuary 2000DoDo
Guidance for Industry: Stability Testing for Medicated Premixes GuidanceMarch 2000DoDo
Guidance for Industry: The Use of Published Literature in Support of New Animal Drug Approval—Draft GuidanceApril 11, 2000DoDo
Guidance for Industry: Dioxin In Anti-Caking Agents Used In Animal Feed And Feed IngredientsRevised April 12, 2000DoDo
Guidance for Industry: Fumonisin Levels in Human Foods and Animal Feeds—Draft GuidanceJune 6, 2000DoDo

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

Name of DocumentDate of IssuanceGrouped by Intended User or Regulatory ActivityHow To Obtain A Hard Copy of The Document (Name and Address, Phone, FAX, E-mail, or Internet)
FDA's Development, Issuance, and Use of Guidance DocumentsFebruary 27, 1997FDA Personnel and Regulated IndustryInternet via www.fda.gov/​opacom/​morechoices/​moreindu.html or Office of Policy (301-827-3360)
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
Direct Final Rule GuidanceNovember 21, 1997FDA PersonnelInternet via www.fda.gov/​opacom/​morechoices/​industry/​guidedc.htm or Carol Kimbrough (301-827-3480)
Industry Supported Scientific and Educational ActivitiesDecember 3, 1997Regulated IndustryInternet via www.fda.gov/​cder/​guidance/​index.htm or Office of Policy (301-827-3360)
Draft Guidance of Broadcast AdvertisementsFebruary 1997DoDo
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 1997DoInternet via www.fda.gov/​opacom/​campaigns/​tobacco/​tobret.htm or 1-888-FDA-4KIDS
Children & Tobacco—Frequently Asked Questions about the new regulations (DRAFT)July 1997DoDo
Children & Tobacco—A Retailer's Guide to the New Federal RegulationsOctober 1997DoDo
Children & Tobacco—A Guide to the New Federal RegulationsOctober 1997DoDo
Start Printed Page 45506
FDA's Standards PolicyOctober 1995FDA Personnel and Regulated Industry60 FR 53078, October 11, 1995 or Office of Policy (301-827-3360)

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

Name of DocumentDate of IssuanceGrouped by Intended User or Regulatory ActivityHow To Obtain A Hard Copy of The Document (Name and Address, Phone, FAX, E-mail, or Internet)
Compliance Policy Guides ManualAugust 1996FDA Staff PersonnelNational Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161 (Order No. PB96-915499) or via Internet www.fda.gov/​ora/​complianceXref/cpg/cpgtc.html
Compliance Policy Guide-DRAFT Commercialization of In Vitro Diagnostic Devices (IVD's) Labeled for Research Use Only or Investigational Use OnlyJanuary 5, 1998DoDo—Internet at www.fda.gov/​cdrh/​comp/​ivddrfg.html
Compliance Policy Guide 675.400 (CPG 7126.24) REVISION Rendered Animal Feed IngredientsNovember 13, 1998DoDo—Internet at www.fda.gov/​ora/​complianceXref/cpg/cpgvet/cpg675.400.html
Compliance Policy Guide DRAFT Distributor Medical Device ReportingAugust 28, 1997FDA Staff Personnel and Regulated IndustryDo—Internet at www.fda.gov/​ora/​complianceXref/cpgXmdr3.txt
Compliance Policy Guide, Chapter 5, Sec. 555.425, NEW: Foods Adulteration Involving Hard or Sharp Foreign ObjectsMarch 23, 1999FDA Staff PersonnelDo—Internet at http://www.fda.gov/​ora/​complianceXref/cpg/cpgfod/cpg555-425.htm
Compliance Policy Guide, Chapter 1, Sec.160.800, NEW:Year 2000 (Y2K) Computer ComplianceApril 26, 1999DoDo—Internet at http://www.fda.gov/​ora/​complianceXref/cpg/cpggenl/cpt160.800.html
Compliance Policy Guide, Chapter 1, Sec. 140.100, REVISION/DRAFT: Regulatory Policy on the Disposition of Publications That Constitute Labeling (CPG 7153.13)April 26, 1999DoDo—Internet at http://www.fda.gov/​ora/​complianceXref/cpg/cpgfod/draftrev-cpg715313.htm
Compliance Policy Guide, Chapter 1, Sec. 160.850: NEW, Enforcement Policy: 21 CFR Part 11; Electronic Records; Electronic Signatures (CPG 7153.17)May 13, 1999DoDo—Internet at htpp://www.fda.gov/​ora/​complianceXref/cpg/cpggenl/cpg160-180.htm
Compliance Policy Guide, Chapter 2, Sec. 230.140, NEW, Evaluation and Processing of Post Donation Information ReportsJuly 9, 1999DoDo—Internet at http://www.fda.gov/​ora/​complianceXref/default.htm
Compliance Policy Guide, Chapter 2, Sec. 252.110, NEW: Volume Limits for Automated Collection of Source PlasmaMarch 6, 2000DoDo—Internet at http://www.fda.gov/​ora/​complianceXref/cpgbio/cpg252.110.htm
Compliance Policy Guide, Chapter 2, Sec. 257.100, REVISED: Deferral of Source Plasma Donors Due to Red Cell Loss During Collection of Source Plasma by Automated PlasmapheresisMarch 22, 2000DoDo—Internet at http://www.fda.gov/​ora/​cmplianceXref/cpg/cpgbio/cpg257.100.htm
Compliance Policy Guide, Chapter 1, Sec. 110.100: REVISED: Certificates for ExportApril 14, 2000DoDo—Internet at http://www.fda.gov/​ora/​complianceXref/cpg/cpggenl/cpg110-100.html
Medical Device Warning Letter PilotMarch 8, 1999FDA Staff Personnel and Regulated IndustryDo—Internet at http://www.fda.gov/​ohrms/​Dockets/​98fr/​030899e.pdf
Start Printed Page 45507
Draft Guidance Policy Statement: Draft Civil Money Penalty Reduction Policy for Small EntitiesMay 18, 1999DoDo—Internet at http://www.fda.gov/​ohrms/​Dockets/​98fr/​051899.txt
Glossary of Computerized System and Software Development TerminologyAugust 1995DoNational Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161 (Order No. PB96-127352) or via Internet www.fda.gov/​ora/​inspectXref/igs/iglist.html
Guidelines for Entry Review of Radiation-Emitting Electronic DevicesMarch 12, 1999FDA Staff PersonnelDivision of Import Operations and Policy (HFC-170), Office of Regional Operations, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-1218
Import AlertsContinuousDoFDA/Freedom of Information Staff (HFI-35), 5600 Fishers Lane, Rockville, MD 20857 or via Internetwww.fda.gov/​ora/​fiars/​oraXimportXalerts.html
Investigations Operations ManualMarch 2000DoDivision of Emergency and Investigational Operations (HFC-130), Office of Regional Operations, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857 301-443-3276 2000 Edition is not yet available on Internet. 1999 Edition is available on Internet at http:// www.fda.gov/​ora/​inspectXref/iom/iomtc.html
Investigations Operations Manual, REVISION: Chapter 4, SamplingJuly 1998DoDo
Investigations Operations Manual, REVISION: Chapter 5, Establishment InspectionsJuly 1998DoDo
Memorandum: ORA Investigational Strategy on Gamma-Butyrolactone (GBL) and Related ProductsMay 15, 2000DoDo—Not available on Internet
Laboratory Procedures ManualJune 1994DoDivision of Field Science (HFC-141), Food and Drug Administration, 5600 Fishers Lane, rm. 12-41, Rockville, MD 20857, ATTN: Donna Porter or via Internet www.fda.gov/​ora/​scienceXref/lpm/lpmtc.html
Laboratory Procedures Manual, Chapter X, NEW: Method Validation SamplesMay 1999DoDo—Not available on Internet
Regulatory Procedures ManualAugust 1997DoNational Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161 (Order No. PB97-196182) or via Internet www.fda.gov/​ora/​complianceXref/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 www.fda.gov/​ora/​complianceXref/rpm/rpmtc.html
Regulatory Procedures Manual: UPDATE Subchapter/Warning LettersMarch 1998DoDo
Regulatory Procedures Manual: UPDATE/REVISION Subchapter/Import ProceduresApril 1998DoDo
Regulatory Procedures Manual; UPDATE/REVISION Subchapter/Priority Enforcement Strategy for Problem ImportersApril 1998DoDo
Start Printed Page 45508
Regulatory Procedures Manual: UPDATE/REVISION Subchapter/Import ProceduresApril 1998DoDo
Regulatory Procedures Manual: UPDATE/REVISION Subchapter/Notice of SamplingApril 1998DoDo
Regulatory Procedures Manual: UPDATE/NEW Subchapter/Granting and Denying Transportation and Exportation (T&E) EntriesMay 1998DoDo
Regulatory Procedures Manual: UPDATE/REVISION Subchapter/SeizureJune 1998DoDo—Internet at www.fda.gov/​ora/​complianceXref/rpmXnew2/ch6.html
Regulatory Procedures Manual: UPDATE/REVISION Subchapter/Supervisory ChargesJune 1998DoDo—Internet at www.fda.gov/​ora/​complianceXref/rpmXnew2/ch9chgs.html
Regulatory Procedures Manual: NEW Subchapter/Civil Penalties—Electronic Product Radiation ControlJuly 1998DoDo—Internet at www.fda.gov/​ora/​complianceXref/ch6civpen.html
Regulatory Procedures Manual, UPDATE/REVISION: Chapter 4, Subchapter/Warning LettersMarch 21, 2000DoDo Internet at http://www.fda.gov/​ora/​complianceXref/rpmXnew2/ch4.html
Guide to Inspections of Bulk Pharmaceutical ChemicalsMay 1994DoNational Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161 (Order No. PB96-127154) or via Internet www.fda.gov/​ora/​inspectXref/igs/iglist.html
Guide to Inspections of Pharmaceutical Quality Control LaboratoriesJuly 1993DoDo—(NTIS Order No. PB96-127279)
Guide to Inspections of Microbiological Pharmaceutical Quality Control LaboratoriesJuly 1993DoDo—(NTIS Order No. PB96-127287)
Guide to Inspections of Validation of Cleaning ProcessesJuly 1993DoDo—(NTIS Order No. PB96-127246)
Guide to Inspections of Lyophilization of ParenteralsJuly 1993DoDo—(NTIS Order No. PB96-127253)
Guide to Inspections of High Purity Water SystemsJuly 1993DoDo—(NTIS Order No. PB96-127261)
Guide to Inspections of Dosage Form Drug Manufacturers-CGMPsOctober 1993DoDo—(NTIS Order No. PB96-127212)
Guide to Inspections of Oral Solid Dosage Forms Pre/Post Approval Issues for Development and ValidationJanuary 1994DoDo—(NTIS Order No. PB96-127345)
Guide to Inspections of Topical Drug ProductsJuly 1994DoDo—(NTIS Order No. PB96-127394)
Guide to Inspections of Sterile Drug Substance ManufacturersJuly 1994DoDo—(NTIS Order No. PB96-127295)
Guide to Inspections of Oral Solutions and SuspensionsAugust 1994DoDo—(NTIS Order No. PB96-127147)
Guide to Inspections of Nutritional Labeling and Education Act (NLEA) RequirementsFebruary 1995DoDo—(NTIS Order No. PB96-127378)
Guide to Inspections of Interstate Carriers and Support FacilitiesApril 1995DoDo—(NTIS Order No. PB96-127386)
Start Printed Page 45509
Guide to Inspections of Dairy Product ManufacturersApril 1995DoDo—(NTIS Order No. PB96-127329)
Guide to Inspections of Miscellaneous Foods Vol. IMay 1995DoDo—(NTIS Order No. PB96-127220)
Guide to Inspections of Miscellaneous Foods Vol. IISeptember 1996DoDo—(NTIS Order No. PB97-196133)
Guide to Inspections of Low Acid Canned Foods Manufacturers, Part 1-Administrative Procedures/Scheduled ProcessesNovember 1996DoDo—(NTIS Order No. PB97-196141)
Guide to Inspections of Low Acid Canned Foods Manufacturers, Part 2- Processes/ProceduresApril 1997DoDo—(NTIS Order No. PB97-196158)
Guide to Inspections of Cosmetic Product ManufacturersFebruary 1995DoDo—(NTIS Order No. PB96-127238)
Guide to Inspections of Blood BanksSeptember 1994DoDo—(NTIS Order No. PB96-127303)
Guide to Inspections of Source Plasma EstablishmentsDecember 1994DoDo—(NTIS Order No. PB96-127360)
Guide to Inspections of Infectious Disease Marker Testing FacilitiesJune 1996DoDo—(NTIS Order No. PB96-199476)
Biotechnology Inspections GuideNovember 1991DoDo—(NTIS Order No. PB96-127402)
Guide to Inspections of Computerized Systems in Drug ProcessingFebruary 1983DoDo—(NTIS Order No. PB96-127337)
Guide to Inspections of Foreign Medical Device ManufacturersSeptember 1995DoDo—(NTIS Order No. PB96-127311)
Guide to Inspections of Foreign Pharmaceutical ManufacturersMay 1996DoDo—(NTIS Order No. PB96-199468)
Mammography Quality Standards Act (MQSA) Auditors GuideJanuary 1998DoDo—(NTIS Order No. PB98-127178)
Guide to Inspections of Electromagnetic Compatibility Aspects of Medical Device Quality SystemsDecember 1997DoDo—(NTIS Order No. PB98-127152)
Guide to Inspections of Grain Product ManufacturersMarch 1998DoDivision of Emergency and Investigational Operations (HFC-130), Office of Regional Operations, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857 301-443-3276
Guide to Bioresearch Monitoring Inspections of In Vitro DevicesFebruary 1998DoDo
Guide to Inspections of Viral Clearance Processes for Plasma DerivativesMarch 1998DoDo
Guide to Traceback of Fresh Fruits and Vegetables Implicated in Epidemiological InvestigationsAugust 1998DoDo
Guide to Inspections of Computerized Systems in the Food Processing IndustryAugust 1998DoDo—Internet at www.fda.gov/​ora/​inspectXref/igf/iglist.html
Guide to International Inspections and Travel, REVISION (Formerly: FDA/ORA International Inspection Manual and Travel Guide)July 1999DoDo Revision not available on Internet
Guide to Inspections of Quality SystemsAugust 1999DoDo—Internet at http://www.fda.gov/​ora/​inspectXref/igs/qsit/QSITGUIDE.PDF
Start Printed Page 45510
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
Computerized Systems Used in Clinical TrialsApril 1999DoDo—Internet at http://www.fda.gov/​ora/​complianceXref/bimo/ffinalcct.htm
Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency ResearchMarch 30, 2000DoDo—Internet at http;//www.fda.gov/​ora/​complianceXref/bimoXerr-guide.htm
Compliance Program 7348.808: Bioresearch Monitoring; Good Laboratory Practices (Nonclinical)Revised August 17, 1998FDA Staff PersonnelDo—Internet http://www.fda.gov/​ora/​complianceXref/bimo/default.html
Compliance Program 7348.810: Sponsors, Contract Research Organizations and MonitorsRevised October 30, 1998DoDo
Compliance Program 7348.811: Bioresearch Monitoring; Clinical InvestigationsRevised September 2, 1998DoDo
Food 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
Compliance Program 7348.809; Bioresearch Monitoring; Institutional Review BoardAugust 18, 1994DoDo
Good Laboratory Practice Regulations Management BriefingsAugust 1979DoDo—Internet at www.fda.gov/​ora/​complianceXref/bimo/default.html
Start Signature

Dated: July 14, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. 00-18497 Filed 7-20-00; 8:45 am]

BILLING CODE 4160-01-F