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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.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

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 It also provides information on guidance documents that have been added or withdrawn in the past year.

DATES:

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

ADDRESSES:

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

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FOR FURTHER INFORMATION CONTACT:

Regarding GGPs: Lisa Helmanis, Office of Policy (HF-26), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3480.

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SUPPLEMENTARY INFORMATION:

I. Background

FDA's GGPs were published in the Federal Register of September 19, 2000 (65 FR 56468), and became effective October 19, 2000. GGPs are intended to ensure involvement of the public in the development of guidance documents, and to enhance understanding of the availability, nature, and legal effect of such guidance (§ 10.115 (21 CFR 10.115)). In § 10.115(n)(2), FDA stated that it intended to publish an annual comprehensive list of guidance documents. The list in this document updates a comprehensive list that published October 24, 2001 (66 FR 53836).

The following comprehensive list identifies all guidances that have been issued and are in use, and all draft guidances that have been distributed for comment and not for implementation. Any guidances that have been withdrawn since the last publication of this comprehensive list are also identified. These withdrawn guidances include some final and draft guidances that had been withdrawn prior to the date of publication of this list, and some that are being withdrawn as of this date. In accordance with the agency's general policy on guidances, you may comment on this list and on any FDA guidance document at any time. Please note that although we have stated that the “Guidance for Industry on Qualified Health Claims in Labeling of Conventional Foods and Dietary Supplements” (December 2002) has been “replaced” by subsequent guidance, the agency has not abandoned the position in the 2002 guidance regarding reasonable consumer standard.

We have organized the documents by the issuing center or office within FDA, and have identified the pertinent intended users or regulatory activities. The dates in the list refer to the date we issued the guidances or, where applicable, the last date we revised a document. Because each issuing center or office maintains its own database, there are slight variations in the way in which they provide information in the tables in this document.

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

Guidance Documents Issued by CBER

Name of DocumentDate of IssuanceIntended User or Regulatory ActivityHow to Obtain a Copy of the Document
Mailing AddressInternet Address
Guidelines for Immunization of Source Plasma (Human) Donors With Blood SubstancesJune 1980FDA regulated industryOffice of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 1-800-835-4709 or 301-827-1800http://www.fda.gov/​cber/​guidelines.htm
Collection of Human Leukocytes for Further Manufacturing (Source Leukocytes)January 28, 1981Ditto (Do)Do.http://www.fda.gov/​cber/​memo.htm
Interferon Test Procedures: Draft Points to Consider (PTC) in the Production and Testing of Interferon Intended for Investigational Use in HumansJuly 28, 1983Do.Do.http://www.fda.gov/​cber/​guidelines.htm
Deferral of Blood Donors Who Have Received the Drug Accutane (isotretinoin/Roche; 13-cis-retinoic acid)February 28, 1984Do.Do.http://www.fda.gov/​cber/​memo.htm
Equivalent Methods for Compatibility TestingDecember 14, 1984Do.Do.Do.
Plasma Derived From Therapeutic Plasma ExchangeDecember 14, 1984Do.Do.Do.
Draft PTC in the Production and Testing of New Drugs and Biologicals Produced by Recombinant DNA TechnologyApril 10, 1985Do.Do.http://www.fda.gov/​cber/​guidelines.htm
Reduction of the Maximum Platelet Storage Period to 5 Days in an Approved ContainerJune 2, 1986Do.Do.http://www.fda.gov/​cber/​memo.htm
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, 1986Do.Do.Do.
Guideline on General Principles of Process ValidationMay 1987Do.Do.http://www.fda.gov/​cber/​guidelines/​htm
Deferral of Donors Who Have Received Human Pituitary-Derived Growth HormoneNovember 25, 1987Do.Do.http://www.fda.gov/​cber/​memo.htm
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 1987Do.Do.http://www.fda.gov/​cber/​guidelines.htm
Recommendations for the Management of Donors and Units That Are Initially Reactive for Hepatitis B Surface Antigen (HbsAg)December 2, 1987Do.Do.http://www.fda.gov/​cber/​memo.htm
Extension of Dating Period for Storage of Red Blood Cells, FrozenDecember 4, 1987Do.Do.Do.
To Licensed In Vitro Diagnostic Manufacturers: Handling of Human Blood Source MaterialsDecember 23, 1987Do.Do.Do.
Recommendations for Implementation of Computerization in Blood EstablishmentsApril 6, 1988Do.Do.Do.
Control of Unsuitable Blood and Blood ComponentsApril 6, 1988Do.Do.Do.
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Discontinuance of Prelicensing Inspection for Immunization Using Licensed Tetanus Toxoid and Hepatitis B and Rabies VaccinesJuly 7, 1988Do.Do.Do.
Physician SubstitutesAugust 15, 1988Do.Do.Do.
To Licensed Manufacturers of Blood Grouping Reagents: Criteria for Exemption of Lot ReleaseAugust 26, 1988Do.Do.Do.
Revised Guideline for the Collection of Platelets, PheresisOctober 7, 1988Do.Do.Do.
To Manufacturers of HTLV-I Antibody Test Kits: Antibody to Human T-Cell Lymphotropic Virus, Type I (HTLV-I) Release Panel IOctober 18, 1988Do.Do.Do.
HTLV-1 Antibody TestingNovember 29, 1988Do.Do.Do.
Use of Recombigen HIV-1 LA TestFebruary 1, 1989Do.Do.Do.
Guidance for Autologous Blood and Blood ComponentsMarch 15, 1989Do.Do.Do.
Use of Recombigen HIV-1 Latex Agglutination (LA) TestAugust 1, 1989Do.Do.Do.
Draft PTC in the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Antibodies to the Human Immunodeficiency Virus, Type 1August 8, 1989Do.Do.http://www.fda.gov/​cber/​guidelines.htm
PTC in the Collection, Processing, and Testing of Ex Vivo Activated Mononuclear Leukocytes for Administration to HumansAugust 22, 1989Do.Do.Do.
Requirements for Computerization of Blood EstablishmentsSeptember 8, 1989Do.Do.http://www.fda.gov/​cber/​memo.htm
Abbott Laboratories' HIVAG-1 Test for HIV-1 Antigen(s) Not Recommended for Use as a Donor ScreenOctober 4, 1989Do.Do.Do.
Guideline for Collection of Blood or Blood Products From Donors With Positive Tests for Infectious Disease Markers (“High Risk” Donors)October 26, 1989Do.Do.Do.
Guideline for the Determination of Residual Moisture in Dried Biological ProductsJanuary 1990Do.Do.http://www.fda.gov/​cber/​guidelines.htm
Autologous Blood Collection and Processing ProceduresFebruary 12, 1990Do.Do.http://www.fda.gov/​cber/​memo.htm
Use of Genetic Systems HIV-2 EIAJune 21, 1990Do.Do.Do.
FDA Request for Information on Blood Storage Patterns and Red Cell Contamination by Yersinia EnterocoliticaMarch 15, 1991Do.Do.Do.
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)April 17, 1991Do.Do.Do.
Deficiencies Relating to the Manufacture of Blood and Blood ComponentsMarch 20, 1991Do.Do.Do.
Responsibilities of Blood Establishments Related to Errors and Accidents in the Manufacture of Blood and Blood ComponentsMarch 20, 1991Do.Do.Do.
FDA Recommendations Concerning Testing for Antibody to Hepatitis B Core Antigen (Anti-HBc)September 10, 1991Do.Do.Do.
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Disposition of Blood Products Intended for Autologous Use That Test Repeatedly Reactive for Anti-HCVSeptember 11, 1991Do.Do.Do.
Clarification of FDA Recommendations for Donor Deferral and Product Distribution Based on the Results of Syphilis TestingDecember 12, 1991Do.Do.Do.
Supplement to the PTC in the Production and Testing of New Drugs and Biologics Produced by Recombinant DNA Technology: Nucleic Acid Characterization and Genetic StabilityApril 6, 1992Do.Do.http://www.fda.gov/​cber/​guidelines.htm
Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood ProductsApril 23, 1992Do.Do.http://www.fda.gov/​cber/​memo.htm
Use of Fluorognost HIV-1 Immunofluorescent Assay (IFA)April 23, 1992Do.Do.Do.
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, 1992Do.Do.Do.
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, 1992Do.Do.Do.
Changes in Equipment for Processing Blood Donor SamplesJuly 21, 1992Do.Do.Do.
Nomenclature for Monoclonal Blood Grouping ReagentsSeptember 28, 1992Do.Do.Do.
Volume Limits for Automated Collection of Source PlasmaNovember 4, 1992Do.Do.Do.
FDA's Policy Statement Concerning Cooperative Manufacturing Arrangements for Licensed BiologicsNovember 25, 1992Do.Do.http://www.fda.gov/​cber/​guidelines.htm
Revision of October 7, 1988, Memo Concerning Red Blood Cell Immunization ProgramsDecember 16, 1992Do.Do.http://www.fda.gov/​cber/​memo.htm
Draft PTC in the Characterization of Cell Lines Used to Produce BiologicalsJuly 12, 1993Do.Do.http://www.fda.gov/​cber/​guidelines.htm
Guidance on Alternatives to Lot Release for Licensed Biological ProductsJuly 20, 1993Do.Do.Do.
Recommendations Regarding License Amendments and Procedures for Gamma Irradiation of Blood ProductsJuly 22, 1993Do.Do.http://www.fda.gov/​cber/​memo.htm
Deferral of Blood and Plasma Donors Based on MedicationsJuly 28, 1993Do.Do.Do.
Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma, and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV)August 5, 1993Do.Do.Do.
Clarification of the Use of Unlicensed Anti-HCV Supplemental Test Results in Regard to Donor NotificationAugust 19, 1993Do.Do.Do.
Draft Guideline for the Validation of Blood Establishment Computer SystemsSeptember 28, 1993Do.Do.http://www.fda.gov/​cber/​guidelines.htm
Guidance Regarding Post Donation Information ReportsDecember 10, 1993Do.Do.http://www.fda.gov/​cber/​memo.htm
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Donor Suitability Related to Laboratory Testing for Viral Hepatitis and a History of Viral HepatitisDecember 22, 1993Do.Do.Do.
Recommendations for the Invalidation of Test Results When Using Licensed Viral Marker Assays to Screen DonorsJanuary 3, 1994Do.Do.Do.
Recommendations for Deferral of Donors for Malaria RiskJuly 26, 1994Do.Do.Do.
Office of Establishment Licensing and Product Surveillance (OELPS), Advertising and Promotional Labeling Staff, Procedural Guidance Document (Draft)August 1994Do.Do.http://www.fda.gov/​cber/​guidelines.htm
Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for Synthetic Peptide SubstancesNovember 1994Do.Do.Do.
Recommendations to Users of Medical Devices That Test for Infectious Disease Markers by Enzyme Immunoassay (EIA) Test SystemsDecember 20, 1994Do.Do.http://www.fda.gov/​cber/​memo.htm
Timeframe for Licensing Irradiated Blood ProductsFebruary 3, 1995Do.Do.Do.
Revision of August 27, 1982, FDA Memo: Requirements for Infrequent Plasmapheresis DonorsMarch 10, 1995Do.Do.Do.
To All Licensed Establishments Performing Red Blood Cell Immunizations: Revised Recommendations for Red Blood Cell Immunization Programs for Source Plasma DonorsMarch 14, 1995Do.Do.Do.
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, 1995Do.Do.Do.
Guideline for Quality Assurance in Blood EstablishmentsJuly 11, 1995Do.Do.http://www.fda.gov/​cber/​guidelines.htm
FDA Guidance Document Concerning Use of Pilot Manufacturing Facilities for the Development and Manufacture of Biological ProductsJuly 11, 1995Do.Do.Do.
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, 1995Do.Do.http://www.fda.gov/​cber/​memo.htm
Recommendations for Donor Screening With a Licensed Test for HIV-1 AntigenAugust 8, 1995Do.Do.Do.
PTC in the Manufacture and Testing of Therapeutic Products for Human Use Derived From Transgenic Animals1995Do.Do.http://www.fda.gov/​cber/​guidelines.htm
Draft Reviewers' Guide: Informed Consent for Plasmapheresis/ImmunizationOctober 1, 1995FDA personnelDo.Do.
Draft Reviewers' Guide: Disease Associated Antibody Collection ProgramOctober 1, 1995Do.Do.Do.
Draft Document Concerning the Regulation of Placental/Umbilical Cord Blood Stem Cell Products Intended for Transplantation or Further Manufacturing Into Injectable ProductsDecember 1995Do.Do.http://www.fda.gov/​cber/​memo.htm
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Donor Deferral Due to Red Blood Cell Loss During Collection of Source Plasma by Automated PlasmapheresisDecember 4, 1995FDA regulated industryDo.Do.
Draft Document Concerning the Regulation of Peripheral Blood Hematopoietic Stem Cell Products Intended for Transplantation or Further Manufacturing Into Injectable ProductsFebruary 1996Do.Do.Do.
International Conference on Harmonisation (ICH) Final Guideline on Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein ProductsFebruary 23, 1996Do.Do.http://www.fda.gov/​cber/​guidelines.htm
ICH Final Guideline on the Need for Long-Term Rodent Carcinogenicity Studies of PharmaceuticalsMarch 1, 1996Do.Do.Do.
Additional Recommendations for Donor Screening With a Licensed Test for HIV-1 AntigenMarch 14, 1996Do.Do.http://www.fda.gov/​cber/​memo.htm
FDA Guidance Concerning Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-Derived ProductsApril 1996Do.Do.http://www.fda.gov/​cber/​guidelines.htm
Additional Recommendations for Testing Whole Blood, Blood Components, Source Plasma, and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV)May 16, 1996Do.Do.http://www.fda.gov/​cber/​memo.htm
Guidance for Industry—The Content and Format for Pediatric Use SupplementsMay 1996Do.Do.http://www.fda.gov/​cber/​guidelines.htm
Guidance on Applications for Products Comprised of Living Autologous Cells Manipulated Ex Vivo and Intended for Structural Repair or ReconstructionMay 1996Do.Do.Do.
Recommendations and Licensure Requirements for Leukocyte-Reduced Blood ProductsMay 29, 1996Do.Do.http://www.fda.gov/​cber/​memo.htm
ICH Final Guidelines on Stablity Testing of Biotechnological/Biological ProductsJuly 10, 1996Do.Do.http://www.fda.gov/​cber/​guidelines.htm
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, 1996Do.Do.http://www.fda.gov/​cber/​memo.htm
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 1996Do.Do.http://www.fda.gov/​cber/​guidelines.htm
Interim Recommendations for Deferral of Donors at Increased Risk for HIV-1 Group O InfectionDecember 11, 1996Do.Do.http://www.fda.gov/​cber/​memo.htm
PTC on Plasmid DNA Vaccines for Preventive Infectious Disease IndicationsDecember 1996Do.Do.http://www.fda.gov/​cber/​guidelines.htm
Guidance for the Submission of Chemistry, Manufacturing, and Controls Information and Establishment Description for Autologous Somatic Cell Therapy ProductsJanuary 1997Do.Do.Do.
Reviewer Guidance for a Premarket Notification Submission for Blood Establishment Computer SoftwareJanuary 13, 1997FDA personnelDo.Do.
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PTC in the Manufacture and Testing of Monoclonal Antibody Products for Human UseFebruary 28, 1997FDA regulated industryDo.Do.
Proposed Approach to Regulation of Cellular and Tissue-Based ProductsFebruary 28, 1997Do.Do.Do.
Guidance for Industry for the Evaluation of Combination Vaccines for Preventable Diseases: Production, Testing, and Clinical StudiesApril 1997Do.Do.Do.
ICH Guidelines for the Photostability Testing of New Drug Substances and ProductsMay 16, 1997Do.Do.Do.
Guidance for Industry: Changes to an Approved Application: Biological ProductsJuly 1997Do.Do.Do.
Guidance for Industry: Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological ProductsJuly 1997Do.Do.Do.
Guidance for Industry: Screening and Testing of Donors of Human Tissue Intended for TransplantationJuly 1997Do.Do.Do.
Guidance for Industry: Donor Screening for Antibodies to HTLV-IIAugust 1997Do.Do.Do.
Guidance for Industry: Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to ReportAugust 1997Do.Do.Do.
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 1997Do.Do.Do.
Guidance for FDA and Industry: Direct Final Rule ProceduresNovember 21, 1997FDA personnel and regulated industryDo.Do.
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.Do.
Guidance for Industry: Industry-Supported Scientific and Educational ActivitiesNovember 1997Do.Do.Do.
Guidance for Industry: Year 2000 Date Change for Computer Systems and Software Applications Used in the Manufacture of Blood ProductsJanuary 1998Do.Do.Do.
Draft Guidance for Industry: Container and Closure Integrity Testing In Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile ProductsJanuary 28, 1998Do.Do.Do.
Draft Guidance for Industry: Manufacturing, Processing, or Holding Active Pharmaceutical IngredientsMarch 1998Do.Do.Do.
Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene TherapyMarch 1998Do.Do.Do.
Draft Guidance for Industry: Instructions for Submitting Electronic Lot Release Protocols to CBERMay 1998Do.Do.Do.
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Guidance for Industry: Classifying Resubmissions in Response to Action LettersMay 14, 1998Do.Do.Do.
Guidance for Industry: Pharmacokinetics in Patients With Impaired Renal Function—Study Design, Data Analysis, and Impact on Dosing and LabelingMay 1998Do.Do.Do.
Guidance for Industry: Standards for the Prompt Review of Efficacy Supplements, Including Priority Efficacy SupplementsMay 15, 1998Do.Do.Do.
Guidance for Industry: Providing Clinical Evidence of Effectiveness for Human Drugs and Biological ProductsMay 1998Do.Do.Do.
Draft Guidance for Industry: Stability Testing of Drug Substances and Drug ProductsJune 1998Do.Do.Do.
Guidance for Industry: Errors and Accidents Regarding Saline Dilution of Samples Used for Viral Marker TestingJune 1998Do.Do.Do.
ICH Guidance on Ethnic Factors in the Acceptability of Foreign Clinical DataJune 10, 1998Do.Do.Do.
Draft Guidance for Industry: Exports and Imports Under the FDA Export Reform and Enhancement Act of 1996June 12, 1998Do.Do.Do.
Guidance for Industry: Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997—Elimination of Certain Labeling RequirementsJuly 1998Do.Do.Do.
Guidance for Industry: Environmental Assessment of Human Drug and Biologics ApplicationsJuly 1998Do.Do.Do.
Draft Guidance for Industry: Submitting Debarment Certification StatementsSeptember 1998Do.Do.Do.
Guidance for Industry: How to Complete the Vaccine Adverse Event Reporting System Form (VAERS-1)September 1998Do.Do.Do.
Guidance for Industry: Fast Track Drug Development Programs—Designation, Development, and Application ReviewJuly 2004Do.Do.Do.
ICH Guidance on Statistical Principles for Clinical TrialsSeptember 16, 1998Do.Do.Do.
ICH Guidance on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological ProductsSeptember 21, 1998Do.Do.Do.
ICH Guidance on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal OriginSeptember 24, 1998Do.Do.Do.
Draft Guidance for Industry: General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological ProductsNovember 1998Do.Do.Do.
Guidance for Industry: FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological ProductsDecember 1998Do.Do.Do.
Draft Guidance for Industry: Product Name Placement, Size, and Prominence in Advertising and Promotional LabelingJanuary 1999Do.Do.Do.
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Guidance for Industry: Content and Format of Chemistry, Manufacturing, and Controls Information and Establishment Description Information for a Vaccine or Related ProductJanuary 1999Do.Do.Do.
Guidance on Amended Procedures for Advisory Panel MeetingsJanuary 26, 1999Do.Do.Do.
Draft Guidance for Industry; Providing Regulatory Submissions in Electronic Format—General ConsiderationsOctober 2003Do.Do.http://www.fda.gov/​cber/​esub/​esubguid.htm
Guidance for Industry: Population PharmacokineticsFebruary 1999Do.Do.http://www.fda.gov/​cber/​guidelines.htm
Guidance for Industry: Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA)February 1999Do.Do.Do.
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 1999Do.Do.Do.
Draft Guidance for Industry: Accelerated Approval Products—Submission of Promotional MaterialsMarch 1999Do.Do.Do.
Guidance for Industry: Content and Format of Chemistry, Manufacturing, and Controls Information and Establishment Description Information for a Biological In Vitro Diagnostic ProductMarch 1999Do.Do.Do.
Guidance for Industry: Public Health Issues Posed by the Use of Nonhuman Primate Xenografts in HumansApril 1999Do.Do.Do.
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 1999Do.Do.Do.
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 1999Do.Do.Do.
Draft Guidance for Industry for Platelet Testing and Evaluation of Platelet Substitute ProductsMay 1999Do.Do.Do.
Guidance for Industry: Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured for Commercial UseMay 1999Do.Do.Do.
Draft Reviewer Guidance: Evaluation of Human Pregnancy Outcome DataJune 1999FDA personnelDo.Do.
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.Do.
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ICH Guidance on the Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing)June 25, 1999Do.Do.Do.
Draft Guidance for Industry: Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis (OA)July 1999Do.Do.Do.
Draft Guidance for Industry: Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug RegulationsJuly 1999Do.Do.Do.
Draft Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed BiologicsAugust 1999Do.Do.Do.
Guidance for Industry: Consumer-Directed Broadcast AdvertisementsAugust 1999Do.Do.Do.
Guidance for Industry: Possible Dioxin/PCB Contamination of Drug and Biological ProductsAugust 1999Do.Do.Do.
Guidance for Industry: Submission of Abbreviated Reports and Synopses in Support of Marketing ApplicationsAugust 1999Do.Do.Do.
ICH Guidance on Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological ProductsAugust 18, 1999Do.Do.Do.
Guidance for Industry: Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic ActSeptember 1999Do.Do.Do.
Guidance for Industry: Providing Regulatory Submissions to 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 1999Do.Do.Do.
Guidance for Industry: In Vivo Drug Metabolism/Drug Interaction Studies—Study Design, Data Analysis, and Recommendations for Dosing and LabelingNovember 1999Do.Do.Do.
ICH of Technical Requirements for Registration of Pharmaceuticals for Human Use; M4: Common Technical DocumentNovember 8, 1999Do.Do.Do.
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 1999Do.Do.Do.
Guidance for Reviewers: Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines: A Revised ProtocolNovember 2000FDA personnelDo.Do.
Guidance for Industry: Formal Meetings With Sponsors and Applicants for PDUFA ProductsFebruary 2000FDA regulated industryDo.Do.
Guidance for Industry: Formal Dispute Resolution: Appeals Above the Division LevelFebruary 2000Do.Do.Do.
Guidance for Industry: Gamma Irradiation of Blood and Blood Components: A Pilot Program for LicensingFebruary 2000Do.Do.Do.
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Draft Guidance for Industry: Content and Format of the Adverse Reactions Section of Labeling for Human Prescription Drugs and BiologicsMay 2000Do.Do.Do.
Guidance for Industry: Recognition and Use of a Standard for the Uniform Labeling of Blood and Blood ComponentsJune 2000Do.Do.Do.
Draft Guidance for Industry: Recommendations for Donor Questioning Regarding Possible Exposure to MalariaJune 2000Do.Do.Do.
Draft Guidance for Industry: Pediatric Oncology Studies in Response to a Written RequestJune 2000Do.Do.Do.
Guidance for Industry: Availability of Licensed Donor Screening Tests Labeled for Use With Cadaveric Blood SpecimensJune 2000Do.Do.Do.
Draft Guidance for Industry: Chronic Cutaneous Ulcer and Burn Wounds—Developing Products for TreatmentJune 2000Do.Do.Do.
Draft Guidance for Industry: Analytical Procedures and Methods Validation—Chemistry, Manufacturing, and Controls DocumentationAugust 2000Do.Do.Do.
Draft Guidance for Industry: Considerations for Reproductive Toxicity Studies for Preventive Vaccines for Infectious Disease IndicationsAugust 2000Do.Do.Do.
Guidance for Industry: Q & A Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived ProductsOctober 2000Do.Do.Do.
Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Followup of Patients in Clinical Trials Using Retroviral VectorsOctober 2000Do.Do.Do.
Guidance for Industry: Submitting and Reviewing Complete Responses to Clinical HoldsOctober 2000Do.Do.Do.
Guidance for Industry: Testing Limits in Stability Protocols for Standardized Grass Pollen ExtractsNovember 2000Do.Do.Do.
Guidance for Industry: Use of Sterile Connecting Devices in Blood Bank PracticesNovember 2000Do.Do.Do.
Draft Guidance for Industry: Recommendations for Complying With the Pediatric Rule (21 CFR 314.55(a) and 601.27(a))November 2000Do.Do.Do.
ICH Guidance for Industry: E11 Clinical Investigation of Medicinal Products in the Pediatric PopulationDecember 2000Do.Do.Do.
Guidance for Industry: Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User FeesDecember 2000Do.Do.Do.
ICH Guidance on Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical SubstancesDecember 29, 2000Do.Do.Do.
PHS Guideline on Infectious Disease Issues in XenotransplantationJanuary 19, 2001Do.Do.Do.
Start Printed Page 835
Draft Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for TransfusionJanuary 2001Do.Do.Do.
Guidance for Industry: Recommendations for Collecting Red Blood Cells by Automated Apheresis MethodsJanuary 2001Do.Do.Do.
Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format—Prescription Drug Advertising and Promotional LabelingJanuary 2001Do.Do.Do.
Guidance for Industry: Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods—Technical CorrectionFebruary 2001Do.Do.Do.
Draft Guidance for Industry: Disclosing Information Provided to Advisory Committees in Connection With Open Advisory Committee Meetings Related to the Testing or Approval of Biologic Products and Convened by the Center for Biologics Evaluation and ResearchFebruary 2001Do.Do.Do.
Draft Guidance for Industry: Postmarketing Safety Reporting for Human Drug and Biological Products Including VaccinesMarch 2001Do.Do.Do.
Guidance for Industry: Acceptance of Foreign Clinical StudiesMarch 2001Do.Do.Do.
Guidance for Industry: Financial Disclosure by Clinical InvestigatorsMarch 2001Do.Do.Do.
Guidance for Industry: Monoclonal Antibodies Used as Reagents in Drug ManufacturingMarch 2001Do.Do.Do.
Draft Guidance for Industry: Reports on the Status of Postmarketing Studies—Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997April 2001Do.Do.Do.
Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format—Postmarketing Expedited Safety ReportsMay 2001Do.Do.Do.
Guidance for Industry: E10 Choice of Control Group and Related Issues in Clinical TrialsMay 2001Do.Do.Do.
Draft Guidance for Industry: IND Meetings for Human Drugs and Biologics; Chemistry, Manufacturing, and Controls InformationMay 2001Do.Do.Do.
Draft Guidance for Industry: Clinical Studies Section of Labeling for Prescription Drugs and Biologics—Content and FormatJuly 2001Do.Do.Do.
Guidance for Industry: CBER Pilot Licensing Program for Immunization of Source Plasma Donors Using Immunogen Red Blood Cells Obtained From an Outside SupplierJuly 2001Do.Do.Do.
Guidance for Industry: Revised Recommendations Regarding Invalidation of Test Results of Licensed and 510(k) Cleared Bloodborne Pathogen Assays Used to Test DonorsJuly 2001Do.Do.Do.
ICH Guidance for Industry: S7A Safety Pharmacology Studies for Human PharmaceuticalsJuly 2001Do.Do.Do.
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Guidance for FDA Reviewers: Premarket Notification Submissions for Empty Containers for the Collection and Processing of Blood and Blood ComponentsJuly 2001Do.Do.Do.
Guidance for FDA Reviewers: Premarket Notification Submissions for Transfer Sets (Excluding Sterile Connecting Devices)July 2001Do.Do.Do.
Guidance for FDA Reviewers: Premarket Notification Submissions for Blood and Plasma WarmersJuly 2001Do.Do.Do.
Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further ManufactureJuly 2001Do.Do.Do.
Draft Guidance for FDA Reviewers: Premarket Notification Submissions for Automated Testing Instruments Used in Blood EstablishmentsAugust 2001Do.Do.Do.
Draft Guidance for Industry: Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other Than Blood and Blood ComponentsAugust 2001Do.Do.Do.
Draft Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma EstablishmentsAugust 2001Do.Do.Do.
Guidance for Industry: Variances for Blood Collection From Individuals With Hereditary HemochromatosisAugust 2001Do.Do.Do.
Draft Guidance for Industry: Submitting Type V Drug Master Files to the CBERAugust 2001Do.Do.Do.
Draft Guidance for Industry: Premarket Notifications (510(k)s) for In Vitro HIV Drug Resistance Genotype Assays: Special ControlsAugust 2001Do.Do.Do.
Draft Guidance for Industry: Submitting Marketing Applications According to the ICH-CTD Format—General ConsiderationsAugust 2001Do.Do.Do.
ICH Guidance: Q7A Good Manufacturing Practice Guide for Active Pharmaceutical IngredientsAugust 2001Do.Do.Do.
ICH Guidance on M4 Common Technical DocumentAugust 2001Do.Do.Do.
Guidance for Industry: Cancer Drug and Biological Products—Clinical Data in Marketing ApplicationsOctober 2001Do.Do.Do.
Guidance for Industry: Content and Format of Geriatric LabelingOctober 2001Do.Do.Do.
Guidance for Industry: Recommendations for Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Possible Exposure to AnthraxOctober 2001Do.Do.Do.
Draft Guidance for Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring CommitteesNovember 2001Do.Do.Do.
Guidance for Industry: Information Request and Discipline Review Letters Under the Prescription Drug User Fee ActNovember 2001Do.Do.Do.
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Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood ProductsJanuary 2002Do.Do.Do.
Guidance for Industry: General Principles of Software Validation; Final Guidance for Industry and FDA StaffJanuary 2002Do.Do.Do.
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 Intimate ContactsFebruary 2002Do.Do.Do.
Guidance for Industry: Validation of Procedures for Processing of Human Tissues Intended for TransplantationMarch 2002Do.Do.Do.
Guidance for Industry; Information Program on Clinical Trials for Serious or Life-Threatening Diseases and ConditionsMarch 2002Do.Do.http://www.fda.gov/​cber/​gdlns/​clintrial031802.pdf
Guidance for Industry: Providing Regulatory Submissions to CBER in Electronic Format—Investigational New Drug Applications (INDs)March 2002Do.Do.http://www.fda.gov/​cber/​guidelines.htm
Guidance for Industry: E2BM Data Elements for Transmission of Individual Case Safety ReportsApril 2002Do.Do.Do.
Draft Guidance for Industry: A Modified Lot-Release Specification for Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Blood, Blood Components, and Source Plasma DonationsApril 2002Do.Do.Do.
Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics; Chemistry, Manufacturing, and Controls DocumentationMay 1999Do.Do.Do.
Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics; Questions and AnswersMay 2002Do.Do.Do.
Draft Guidelines for Ensuring the Quality of Information Disseminated to the Public (HHS Guideline)May 2002Do.Do.Do.
Guidance for Industry: Special Protocol AssessmentMay 2002Do.Do.Do.
Draft Guidance for Industry: Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)June 2002Do.Do.Do.
Draft Guidance for Industry: 21 CFR Part 11; Electronic Records; Electronic Signatures, Electronic Copies of Electronic RecordsAugust 2002Do.Do.Do.
Guidance for Industry: Establishing Pregnancy Exposure RegistriesAugust 2002Do.Do.Do.
Draft Guidance for Industry: Drugs, Biologics, and Medical Devices Derived From Bioengineered Plants for Use in Humans and AnimalsSeptember 2002Do.Do.Do.
Draft Guidance for Industry: Nonclinical Studies for Development of Pharmaceutical ExcipientsSeptember 2002Do.Do.Do.
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The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles; Final Guidance for FDA and IndustryOctober 2002Do.Do.Do.
Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Human Dura MaterDecember 18, 2003Do.Do.http://www.fda.gov/​cber/​gdlns/​humduramat.pdf
Guidance for Industry: Recommendations for Deferral of Donors and Quarantine and Retrieval of Blood and Blood Products in Recent Recipients of Smallpox Vaccine (Vaccinia Virus) and Certain Contacts of Smallpox Vaccine RecipientsDecember 2002Do.Do.http://www.fda.gov/​cber/​guidelines.htm
Draft Guidance for Industry and Reviewers on Estimating the Safe Starting Dose in Clinical Trials for Therapeutics in Adult Healthy VolunteersDecember 2002Do.Do.Do.
ICH Guidance for Industry; Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and ProductsJanuary 2003Do.Do.Do.
Draft Guidance for Industry: Collection of Race and Ethnicity Data in Clinical TrialsJanuary 2003Do.Do.Do.
Draft Guidance for Industry: Drug Product: Chemistry, Manufacturing, and Controls InformationJanuary 2003Do.Do.Do.
ICH Guidance for Industry: M4 CTD—Safety: Questions and AnswersFebruary 2003Do.Do.Do.
Guidance for Industry and FDA Staff: Quality System Information for Certain Premarket Application ReviewsFebruary 2003Do.Do.Do.
ICH Guidance for Industry: Q3A Impurities in New Drug SubstancesFebruary 2003Do.Do.Do.
Draft Guidance for Industry; Comparability Protocols—Chemistry, Manufacturing, and Controls InformationFebruary 2003Do.Do.Do.
Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination Products; Guidance for Industry and FDAFebruary 25, 2003Do.Do.http://www.fda.gov/​cber/​dap/​devpubs.htm
Guidance for Industry and FDA: FY 2003 MDUFMA Small Business Qualification Worksheet and CertificationMarch 2003Do.Do.http://www.fda.gov/​cber/​guidelines.htm
ICH Guidance for Industry: M2 eCTD: Electronic Common Technical Document SpecificationApril 2003Do.Do.Do.
Guidance for Industry: Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in HumansApril 2003Do.Do.Do.
Guidance for Industry: Recommendations for the Assessment of Donor Suitability and Blood Product Safety in Cases of Suspected Severe Acute Respiratory Syndrome (SARS) or Exposure to SARSApril 2003Do.Do.Do.
Guidance for Industry, FDA Staff, and Third Parties; Implementation of the Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002; Accreditation CriteriaOctober 4, 2004Do.Do.http://www.fda.gov/​cber/​dap/​devpubs.htm
Start Printed Page 839
Guidance for Industry: Exposure-Response Relationships—Study Design, Data Analysis, and Regulatory ApplicationsApril 2003Do.Do.http://www.fda.gov/​cber/​guidelines.htm
Guidance for Industry: Revised Recommendations for the Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus InfectionMay 2003Do.Do.Do.
Guidance for Industry: Pharmacokinetics in Patients With Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and LabelingMay 2003Do.Do.Do.
Draft Guidance for Industry and FDA Staff: Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002—Identification of Manufacturer of Medical DevicesJune 2003Do.Do.Do.
Guidance for FDA Staff: The Leveraging Handbook, An Agency Resource for Effective CollaborationsJune 2003Do.Do.Do.
Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format—Postmarketing Periodic Adverse Drug Experience ReportsJune 2003Do.Do.Do.
Draft Guidance for Industry: Revised Recommendations for Donor and Product Management Based on Screening Tests for SyphilisJune 2003Do.Do.Do.
Guidance for Industry and FDA Staff: Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical DevicesJuly 2003Do.Do.Do.
Guidance for Industry: Streamlining the Donor Interview Process: Recommendations for Self-Administered QuestionnairesJuly 2003Do.Do.Do.
Draft Guidance for Industry and FDA Staff: Premarket Assessment of Pediatric Medical DevicesJuly 2003Do.Do.Do.
Draft Guidance for Review Staff and Industry: Good Review Management Principles for PDUFA ProductsJuly 2003Do.Do.Do.
Compliance Program Guidance Manual (drugs and biologics)Dates vary—Individual issue datesDo.Do.http://www.fda.gov/​cber/​cpg/​cpg.htm
ICH Guidance for Industry: Q3C—Tables and ListNovember 2003Do.Do.http://www.fda.gov/​cber/​guidelines.htm
ICH Guidance for Industry: Q3B(R) Impurities in New Drug ProductsNovember 2003Do.Do.Do.
ICH Guidance for Industry: Q1A(R2) Stability Testing of New Drug Substances and ProductsNovember 2003Do.Do.Do.
WITHDRAWN GUIDANCES
Draft Guidance for Industry: Application of Current Statutory Authority to Nucleic Acid Testing of Pooled PlasmaNovember 1999Do.N/A
Draft Document Concerning the Regulation of Placental/Umbilical Cord Blood Hematopoietic Stem Cell Products Intended for Transplantation or Further Manufacturing Into Injectable ProductsDecember 1995Do.Do.
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Draft Document Concerning the Regulation of Peripheral Blood Hematopoietic Stem Cell Products Intended for Transplantation or Further Manufacturing into Injectable ProductsFebruary 1996Do.Do.
Draft Advertising and Promotional Labeling Staff Procedural GuidanceAugust 1994Do.Do.
Draft Guidance for Industry: 21 CFR Part 11; Electronic Records; Electronic Signatures; ValidationAugust 2001Do.Do.
Draft Guidance for Industry: 21 CFR Part 11; Electronic Records; Electronic Signatures; Glossary of TermsAugust 2001Do.Do.
Draft Guidance for Industry: 21 CFR Part 11; Electronic Records; Electronic Signatures; Time StampsFebruary 2002Do.Do.
Draft Guidance for Industry: 21 CFR Part 11; Electronic Records; Electronic Signatures, Maintenance of Electronic RecordsJuly 2002Do.Do.

Guidance Documents Issued by CDER

Name of DocumentDate of IssuanceIntended User or Regulatory ActivityHow to Obtain a Copy of the Document
Mailing AddressInternet Address
Aerosol Steroid Product Safety Information in Prescription Drug Advertising and Promotional LabelingJanuary 12, 1998AdvertisingDivision of Drug Information (HFD-200), Office of Training and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4573http://www.fda.gov/​cder/​guidance/​index.htm
Consumer-Directed Broadcast AdvertisementsAugust 9, 1999Do.Do.Do.
Industry-Supported Scientific and Educational ActivitiesDecember 3, 1997Do.Do.Do.
Accelerated Approval Products—Submission of Promotional MaterialsMarch 26, 1999Advertising draftDo.Do.
Brief Summary: Disclosing Risk Information in Consumer-Directed Print AdvertisementsFebruary 10, 2004Do.Do.Do.
“Help-Seeking” and Other Disease Awareness Communications by or on Behalf of Drug and Device FirmsFebruary 10, 2004Do.Do.Do.
Product Name Placement, Size, and Prominence in Advertising and Promotional LabelingMarch 12, 1999Do.Do.Do.
Promoting Medical Products in a Changing Healthcare Environment; I. Medical Product Promotion by Healthcare Organizations or Pharmacy Benefits Management Companies (PBMs)January 5, 1998Do.Do.Do.
Bioanalytical Method ValidationMay 23, 2001BiopharmaceuticsDo.Do.
Start Printed Page 841
Bioavailability and Bioequivalence Studies for Orally Administered Drug Products—General ConsiderationsMarch 19, 2003Do.Do.Do.
Cholestyramine Powder In Vitro BioequivalenceJuly 15, 1993Do.Do.Do.
Clozapine Tablets In Vivo Bioequivalence and In Vitro Dissolution TestingNovember 15, 1996Do.Do.Do.
Corticosteroids, Dermatologic (topical) In VivoJune 2, 1995Do.Do.Do.
Dissolution Testing of Immediate Release Solid Oral Dosage FormsAugust 25, 1997Do.Do.Do.
Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo CorrelationsSeptember 26, 1997Do.Do.Do.
Food-Effect Bioavailability and Fed Bioequivalence StudiesDecember 2002Do.Do.Do.
Metaproterenol Sulfate and Albuterol Metered Dose Inhalers In VitroJune 27, 1989Do.Do.Do.
Phenytoin/Phenytion Sodium (capsules, tablets, suspension) In Vivo Bioequivalence and In Vitro Dissolution TestingMarch 4, 1994Do.Do.Do.
Statistical Approaches to Establishing BioequivalenceFebruary 2, 2001Do.Do.Do.
Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification SystemAugust 31, 2000Do.Do.Do.
Antifungal (topical)February 24, 1990Biopharmaceutics draftDo.N/A
Antifungal (vaginal)February 24, 1990Do.Do.Do.
Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local ActionApril 2003Do.Do.http://www.fda.gov/​cder/​guidance/​index.htm
Clozapine Tablets: In Vivo Bioequivalence and In Vitro Dissolution TestingDecember 2003Do.Do.Do.
Conjugated Estrogens, USP-LC-MS Method for Both Qualitative Chemical Characterization and Documentation of Qualitative Pharmaceutical EquivalenceMarch 2000Do.Do.Do.
BACPAC I: Intermediates in Drug Substance Synthesis: Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls DocumentationFebruary 16, 2001ChemistryDo.http://www.fda.gov/​cder/​guidance/​index.htm
Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological ProductsJuly 24, 1997Do.Do.Do.
Changes to an Approved NDA or ANDAApril 2004Do.Do.Do.
Changes to an Approved NDA or ANDA: Questions and AnswersJanuary 22, 2001Do.Do.Do.
Container Closure Systems for Packaging Human Drugs and BiologicsMay 1999Do.Do.Do.
Start Printed Page 842
Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-Derived ProductsApril 1996Do.Do.Do.
Development of New Stereoisomeric DrugsMay 1, 1992Do.Do.Do.
Drug Master FilesSeptember 1, 1989Do.Do.Do.
Drug Master Files for Bulk Antibiotic Drug SubstancesNovember 29, 1999Do.Do.Do.
Environmental Assessment of Human Drug and Biologics ApplicationsJuly 27, 1998Do.Do.Do.
Format and Content for the CMC Section of an Annual ReportSeptember 1, 1994Do.Do.Do.
Format and Content of the Chemistry, Manufacturing, and Controls Section of an ApplicationFebruary 1, 1987Do.Do.Do.
Format and Content of the Microbiology Section of an ApplicationFebruary 1, 1987Do.Do.Do.
IND Meetings for Human Drugs and Biologics; Chemistry, Manufacturing, and Controls InformationMay 25, 2001Do.Do.Do.
INDs for Phase 2 and 3 Studies; Chemistry, Manufacturing, and Controls InformationMay 20, 2003Do.Do.Do.
Monoclonal Antibodies Used as Reagents in Drug ManufacturingMarch 29, 2001Do.Do.Do.
Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products—Chemistry, Manufacturing, and Controls DocumentationJuly 5, 2002Do.Do.Do.
NDAs: Impurities in Drug SubstancesFebruary 25, 2000Do.Do.Do.
PAC-ALTS: Postapproval Changes—Analytical Testing Laboratory SitesApril 28, 1998Do.Do.Do.
Reviewer Guidance: Validation of Chromatographic MethodsNovember 1994Do.Do.Do.
Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug ProductsNovember 1, 1994Do.Do.Do.
Submission of Chemistry, Manufacturing, and Controls Information for Synthetic Peptide SubstancesNovember 1994Do.Do.Do.
Submitting Documentation for the Manufacturing of, and Controls for, Drug ProductsFebruary 1, 1987Do.Do.Do.
Submitting Documentation for the Stability of Human Drugs and BiologicsFebruary 1, 1987Do.Do.Do.
Submitting Samples and Analytical Data for Methods ValidationFebruary 1987Do.Do.Do.
Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug ProductsFebruary 1, 1987Do.Do.N/A
Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug SubstancesFebruary 1987Do.Do.http://www.fda.gov/​cder/​guidance/​index.htm
Start Printed Page 843
SUPAC IR—Immediate-Release Solid Oral Dosage Forms: Scale-Up and Postapproval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence DocumentationNovember 1995Do.Do.Do.
SUPAC IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms Manufacturing Equipment AddendumJanuary 1999Do.Do.Do.
SUPAC-IR Questions and Answers About SUPAC-IR GuidanceFebruary 18, 1997Do.Do.Do.
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, 1997Do.Do.Do.
SUPAC-SS—Nonsterile Semisolid Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Release Testing and In Vivo Bioequivalence DocumentationMay 1997Do.Do.Do.
The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE)December 20, 2000Do.Do.Do.
Analytical Procedures and Methods Validation: Chemistry, Manufacturing, and Controls DocumentationAugust 30, 2000Chemistry draftDo.Do.
Botanical Drug ProductsJune 9, 2004Do.Do.Do.
Comparability Protocols—Chemistry, Manufacturing, and Controls InformationFebruary 25, 2003Do.Do.Do.
Drug Product: Chemistry, Manufacturing, and Controls InformationJanuary 28, 2003Do.Do.Do.
Drug Substance: Chemistry, Manufacturing, and Controls InformationJanuary 7, 2004Do.Do.Do.
Drugs, Biologics, and Medical Devices Derived From Bioengineered Plants for Use in Humans and AnimalsSeptember 2002Do.Do.Do.
Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug RegulationsJuly 1999Do.Do.
Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling DocumentationAugust 2002Do.Do.Do.
Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products; Chemistry, Manufacturing, and Controls DocumentationNovember 19, 1998Do.Do.Do.
Stability Testing of Drug Substances and Drug ProductsJune 8, 1998Do.Do.Do.
Submitting Supporting Chemistry Documentation in Radiopharmaceutical Drug ApplicationsNovember 1, 1991Do.Do.N/A
SUPAC-SS: Nonsterile Semisolid Dosage Forms Manufacturing Equipment AddendumJanuary 5, 1999Do.Do.http://www.fda.gov/​cder/​guidance/​index.htm
Start Printed Page 844
Antiretroviral Drugs Using Plasma HIV RNA Measurements—Clinical Considerations for Accelerated and Traditional ApprovalOctober 2002Clinical antimicrobialDo.Do.
Clinical Development and Labeling of Anti-Infective Drug ProductsOctober 26, 1992Do.Do.Do.
Clinical Evaluation of Anti-Infective Drugs (Systemic)September 1, 1977Do.Do.Do.
Preclinical Development of Antiviral DrugsNovember 1990Do.Do.Do.
Acute Bacterial Exacerbation of Chronic Bronchitis; Developing Antimicrobial Drugs for TreatmentJuly 22, 1998Clinical antimicrobial draftDo.Do.
Acute Bacterial Meningitis; Developing Antimicrobial Drugs for TreatmentJuly 22, 1998Do.Do.Do.
Acute Bacterial Sinusitis; Developing Antimicrobial Drugs for TreatmentJuly 22, 1998Do.Do.Do.
Acute or Chronic Bacterial Prostatitis; Developing Antimicrobial Drugs for TreatmentJuly 22, 1998Do.Do.Do.
Acute Otitis Media; Developing Antimicrobial Drugs for TreatmentJuly 22, 1998Do.Do.Do.
Bacterial Vaginosis; Developing Antimicrobial Drugs for TreatmentJuly 22, 1998Do.Do.Do.
Catheter-Related Bloodstream Infections—Developing Antimicrobial Drugs for TreatmentOctober 18, 1999Do.Do.Do.
Community Acquired Pneumonia; Developing Antimicrobial Drugs for TreatmentJuly 22, 1998Do.Do.Do.
Complicated Urinary Tract Infections and Pylonephritis—Developing Antimicrobial Drugs for TreatmentJuly 22, 1998Do.Do.Do.
Developing Antimicrobial Drugs—General Considerations for Clinical TrialsJuly 22, 1998Do.Do.Do.
Developing Drugs to Treat Inhalational Anthrax (Post-Exposure)March 18, 2002Do.Do.Do.
Empiric Therapy of Febrile Neutropenia—Developing Antimicrobial Drugs for TreatmentJuly 22, 1998Do.Do.Do.
Evaluating Clinical Studies of Antimicrobials in the Division of Anti-Infective Drug ProductsFebruary 1997Do.Do.Do.
Lyme Disease—Developing Antimicrobial Drugs for TreatmentJuly 22, 1998Do.Do.Do.
Nosocomial Pneumonia—Developing Antimicrobial Drugs for TreatmentJuly 22, 1998Do.Do.Do.
Secondary Bacterial Infections of Acute Bronchitis—Developing Antimicrobial Drugs for TreatmentJuly 22, 1998Do.Do.Do.
Streptococcal Pharyngitis and Tonsillitis—Developing Antimicrobial Drugs for TreatmentJuly 22, 1998Do.Do.Do.
Uncomplicated and Complicated Skin and Skin Structure Infections—Developing Antimicrobial Drugs for TreatmentJuly 22, 1998Do.Do.Do.
Start Printed Page 845
Uncomplicated Gonorrhea—Developing Antimicrobial Drugs for TreatmentJuly 22, 1998Do.Do.Do.
Uncomplicated Urinary Tract Infections—Developing Antimicrobial Drugs for TreatmentJuly 22, 1998Do.Do.Do.
Vaccinia Virus—Developing Drugs to Mitigate Complications From Smallpox VaccinationMarch 2004Do.Do.Do.
Vuvlovaginal Candidiasis—Developing Antimicrobial Drugs for TreatmentJuly 22, 1998Do.Do.Do.
Acceptance of Foreign Clinical StudiesMarch 2001Clinical medicalDo.Do.
Calcium DTPA and Zinc DTPA Drug Products—Submitting a New Drug ApplicationAugust 2004Do.Do.Do.
Cancer Drug and Biological Products—Clinical Data in Marketing ApplicationsOctober 2001Do.Do.Do.
Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA)February 1999Do.Do.Do.
Clinical Development Programs for MDI and DPI Drug ProductsSeptember 19, 1994Do.Do.Do.
Clinical Evaluation of Anti-Inflammatory and Antirheumatic Drugs (adults and children)April 1988Do.Do.Do.
Clinical Evaluation of Antianxiety DrugsSeptember 1, 1977Do.Do.Do.
Clinical Evaluation of Antidepressant DrugsSeptember 1, 1977Do.Do.Do.
Clinical Evaluation of Antiepileptic Drugs (adults and children)January 1, 1981Do.Do.Do.
Clinical Evaluation of General AnestheticsMay 1, 1982Do.Do.Do.
Clinical Evaluation of Hypnotic DrugsSeptember 1, 1977Do.Do.Do.
Clinical Evaluation of Local AnestheticsMay 1982Do.Do.Do.
Clinical Evaluation of Psychoactive Drugs in Infants and ChildrenJuly 1979Do.Do.Do.
Content and Format for Pediatric Use SupplementsMay 1996Do.Do.Do.
Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived ProductsNovember 1995Do.Do.Do.
Establishing Pregnancy Exposure RegistriesAugust 2002Do.Do.Do.
FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological ProductsFebruary 2, 1999Do.Do.Do.
FDA Requirements for Approval of Drugs to Treat Non-Small Cell Lung CancerJanuary 1991Do.Do.Do.
Format and Content of the Clinical and Statistical Sections of an ApplicationJuly 1, 1988Do.Do.Do.
Format and Content of the Summary for New Drug and Antibiotic ApplicationsFebruary 1, 1987Do.Do.Do.
Formatting, Assembling and Submitting New Drug and Antiobiotic ApplicationsFebruary 1, 1987Do.Do.Do.
Start Printed Page 846
General Considerations for the Clinical Evaluation of DrugsDecember 1, 1978Do.Do.Do.
General Considerations for the Clinical Evaluation of Drugs in Infants and ChildrenSeptember 1, 1977Do.Do.Do.
Guidance for the Development of Vaginal Contraceptive Drugs (NDA)April 1995Do.Do.Do.
IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of CancerJanuary 15, 2004Do.Do.Do.
Integration of Dose-Counting Mechanisms Into MDI Drug ProductsMarch 2003Do.Do.Do.
Levothyroxine Sodium Tablets—In Vivo Pharmacokinetic and Bioavailability Studies and In Vitro Dissolution TestingMarch 8, 2001Do.Do.Do.
Oncologic Drugs Advisory Committee Discussion on FDA Requirements for Approval of New Drugs for Treatment of Colon and Rectal CancerApril 19, 1988Do.Do.Do.
Oncologic Drugs Advisory Committee Discussion on FDA Requirements for Approval of New Drugs for Treatment of Ovarian CancerApril 1988Do.Do.Do.
Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to ReportAugust 27, 1997Do.Do.Do.
Postmarketing Reporting of Adverse Drug ExperiencesMarch 1, 1992Do.Do.Do.
Preclinical Development of Immunomodulatory Drugs for Treatment of HIV Infection and Associated DisordersSeptember 1992Do.Do.Do.
Preparation of Investigational New Drug Products (Human and Animal)November 1, 1992Do.Do.Do.
Providing Clinical Evidence of Effectiveness for Human Drug and Biological ProductsMay 1998Do.Do.Do.
Prussian Blue Drug Products—Submitting a New Drug ApplicationFebruary 4, 2003Do.Do.Do.
Study and Evaluation of Gender Differences in the Clinical Evaluation of DrugsJuly 22, 1993Do.Do.Do.
Study of Drugs Likely to be Used in the ElderlyNovember 1, 1989Do.Do.Do.
Submission of Abbreviated Reports and Synopses in Support of Marketing ApplicationsSeptember 13, 1999Do.Do.Do.
Abuse Liability AssessmentJuly 1, 1990Clinical medical draftDo.N/A
Allergic Rhinitis: Clinical Development Programs for Drug ProductsJune 21, 2000Do.Do.http://www.fda.gov/​cder/​guidance/​index.htm
Available TherapyJuly 22, 2004Do.Do.Do.
Chronic Cutaneous Ulcer and Burn Wounds—Developing Products for TreatmentJune 28, 2000Do.Do.Do.
Start Printed Page 847
Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of Osteoarthritis (OA)July 1999Do.Do.Do.
Clinical Evaluation of Anti-Anginal DrugsJanuary 1, 1989Do.Do.N/A
Clinical Evaluation of Anti-Arrhythmic DrugsJuly 1, 1985Do.Do.Do.
Clinical Evaluation of Antihypertensive DrugsMay 1, 1988Do.Do.Do.
Clinical Evaluation of Drugs for the Treatment of Congestive Heart FailureDecember 1, 1987Do.Do.Do.
Clinical Evaluation of Lipid-Altering Agents in Adults and ChildrenSeptember 1990Do.Do.http://www.fda.gov/​cder/​guidance/​index.htm
Clinical Evaluation of Weight-Control DrugsSeptember 24, 1996Do.Do.Do.
Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring CommitteesNovember 2001Do.Do.Do.
Collection of Race and Ethnicity Data in Clinical Trials for FDA-Regulated ProductsJanuary 30, 2003Do.Do.Do.
Developing Medical Imaging Drug and Biological Products—2nd draftMay 19, 2003Do.Do.Do.
Development and Evaluation of Drugs for the Treatment of Psychoactive Substance Use DisordersFebruary 12, 1992Do.Do.N/A
Development of Parathyroid Hormone for the Prevention and Treatment of OsteoporosisMay 2000Do.Do.http://www.fda.gov/​cder/​guidance/​index.htm
Drugs, Biologics, and Medical Devices Derived From Bioengineered Plants for Use in Humans and AnimalsSeptember 2002Do.Do.Do.
Estrogen and Estrogen/Progestin Drug Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms—Recommendations for Clinical EvaluationJanuary 2003Do.Do.Do.
Evaluation of Human Pregnancy Outcome DataJune 1999Do.Do.Do.
Evaluation of the Effects of Orally Inhaled and Intranasal Corticosteroids on Growth in ChildrenNovember 6, 2001Do.Do.Do.
Exercise-Induced Bronchospasm (EIB)—Development of Drugs to Prevent EIBFebruary 20, 2002Do.Do.Do.
Female Sexual Dysfunction: Clinical Development of Drug Products for TreatmentMay 19, 2000Do.Do.Do.
Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency ResearchMarch 2000Do.Do.Do.
Inhalation Drug Products Packaged in Semipermeable Container Closure SystemsJuly 26, 2002Do.Do.Do.
OTC Treatment of Herpes Labialis with Antiviral AgentsMarch 8, 2000Do.Do.Do.
Pediatric Oncology Studies in Response to a Written RequestJune 21, 2000Do.Do.Do.
Start Printed Page 848
Preclinical and Clinical Evaluation of Agents Used in the Prevention or Treatment of Postmenopausal OsteoporosisApril 1, 1994Do.Do.Do.
Preparation of IND Applications for New Drugs Intended for the Treatment of HIV-Infected IndividualsSeptember 1, 1991Do.Do.N/A
Recommendations for Complying With the Pediatric RuleNovember 2000Do.Do.http://www.fda.gov/​cder/​guidance/​index.htm
Drug Metabolism/Drug Interaction Studies in the Drug Development Process: Studies In VitroApril 7, 1997Clinical pharmacologyDo.Do.
Exposure-Response Relationships—Study Design, Data Analysis, and Regulatory ApplicationsApril 2003Do.Do.Do.
Format and Content of the Human Pharmacokinetics and Bioavailability Section of an ApplicationFebruary 1, 1987Do.Do.Do.
In Vivo Metabolism/Drug Interaction Studies—Study Design, Data Analysis, and Recommendations for Dosing and LabelingNovember 24, 1999Do.Do.Do.
Pharmacokinetics in Patients With Impaired Hepatic Function; Study Design, Data Analysis, and Impact on Dosing and LabelingMay 30, 2003Do.Do.Do.
Pharmacokinetics in Patients with Impaired Renal Function—Study Design, Data Analysis, and Impact on Dosing and LabelingMay 1998Do.Do.Do.
Population PharmacokineticsFebruary 10, 1999Do.Do.Do.
General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological ProductsNovember 30, 1998Clinical pharmacology draftDo.Do.
A Review of FDA's Implementation of the Drug Export Amendments of 1986May 1990ComplianceDo.Do.
Compressed Medical GasesFebruary 1989Do.Do.Do.
Computerized Systems Used in Clinical TrialsApril 1999Do.Do.Do.
Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing IronJune 27, 1997Do.Do.Do.
General Principles of Process ValidationMay 1987Do.Do.Do.
Good Laboratory Practice Regulations Questions and AnswersJune 1981Do.Do.Do.
Guidance for Hospitals, Nursing Homes, and Other Health Care Facilities—FDA Public Health AdvisoryMarch 2001Do.Do.Do.
Guideline for Validation of Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical DevicesDecember 1987Do.Do.Do.
Monitoring of Clinical InvestigationsJanuary 1988Do.Do.Do.
Nuclear Pharmacy Guideline Criteria for Determining When to Register as a Drug EstablishmentMay 1984Do.Do.Do.
Pharmacy Compounding: Compliance Policy GuideMay 2002Do.Do.Do.
Start Printed Page 849
Possible Dioxin/PCB Contamination of Drug and Biological ProductsAugust 23, 1999Do.Do.Do.
Sterile Drug Products Produced by Aseptic ProcessingJune 1987Do.Do.Do.
Street Drug AlternativesMarch 2000Do.Do.Do.
Current Good Manufacturing Practices for Medical GasesMay 6, 2003Compliance draftDo.Do.
Good Manufacturing Practice for Positron Emission Tomography Drug ProductsApril 1, 2002Do.Do.Do.
Guidance for IRBs, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for Emergency ResearchMay 12, 2000Do.Do.Do.
Investigating Out of Specification (OOS) Test Results for Pharmaceutical ProductionSeptember 30, 1998Do.Do.Do.
Manufacture, Processing, or Holding of Active Pharmaceutical IngredientsApril 17, 1998Do.Do.Do.
Marketed Unapproved Drugs—Compliance Policy GuideOctober 2003Do.Do.
Prescription Drug Marketing Act Regulations for Donation of Prescription Drug Samples to Free ClinicsJune 27, 2002Do.Do.Do.
Repackaging of Solid Oral Dosage Form Drug ProductsFebruary 1, 1992Do.Do.N/A
Part 11, Electronic Records; Electronic Signatures—Scope and ApplicationAugust 2003Current good manufacturing practices (CGMPs)Do.http://www.fda.gov/​cder/​guidance/​index.htm
Comparability Protocols—Protein Drug Products and Biological Products—Chemistry, Manufacturing, and Controls InformationSeptember 2003CGMPs draftDo.Do.
Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing PracticesAugust 2003Do.Do.Do.
Powder Blends and Finished Dosage Units—Stratified In-Process Dosage Unit Sampling and AssessmentNovember 7, 2003Do.Do.Do.
Process Analytical Technology—A Framework for Innovative Pharmaceutical Manufacturing and Quality AssuranceOctober 4, 2004Do.Do.Do.
Sterile Drug Products Produced by Aseptic ProcessingOctober 4, 2004Do.Do.Do.
Providing Electronic Submissions in Electronic Format—ANDAsJune 27, 2002Electronic submissionsDo.Do.
Regulatory Submissions in Electronic Format; General ConsiderationsJanuary 28, 1999Do.Do.Do.
Regulatory Submissions in Electronic Format; New Drug ApplicationsJanuary 28, 1999Do.Do.Do.
Providing Regulatory Submissions in Electronic Format—Annual Reports for NDAs and ANDAsAugust 2003Electronic submissions draftDo.Do.
Start Printed Page 850
Providing Regulatory Submissions in Electronic Format—Content of LabelingFebruary 2004Do.Do.Do.
Providing Regulatory Submissions in Electronic Format—General ConsiderationsOctober 22, 2003Do.Do.Do.
Providing Regulatory Submissions in Electronic Format—Human Pharmaceutical Product Applications and Related SubmissionsAugust 29, 2003Do.Do.Do.
Providing Regulatory Submissions in Electronic Format—Postmarketing Expedited Safety ReportsMay 4, 2001Do.Do.Do.
Providing Regulatory Submissions in Electronic Format—Postmarketing Periodic Adverse Drug Experience ReportsJune 2003Do.Do.Do.
Providing Regulatory Submissions in Electronic Format, Prescription Drug Advertising and Promotional LabelingJanuary 31, 2001Do.Do.Do.
180-Day Exclusivity When Multiple Abbreviated New Drug Applications Are Submitted on the Same DayJuly 2003GenericsDo.
Alternate Source of Active Pharmaceutical Ingredients in Pending ANDAsDecember 12, 2000Do.Do.Do.
ANDAs: Impurities in Drug SubstancesNovember 1999Do.Do.Do.
Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic ActMarch 2000Do.Do.Do.
Letter announcing that the OGD will now accept the ICH long-term storage conditions as well as the stability studies conducted in the pastAugust 1995Do.Do.Do.
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 1994Do.Do.Do.
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 1994Do.Do.Do.
Letter on the provision of new information pertaining to new bioequivalence guidelines and refuse-to-file lettersJuly 1992Do.Do.Do.
Letter on the provision of new procedures and policies affecting the generic drug review processMarch 1989Do.Do.Do.
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 1991Do.Do.Do.
Letter on the response to 12/20/84 letter from the Pharmaceutical Manufacturers Association about the Drug Price Competition and Patent Term Restoration ActMarch 1985Do.Do.Do.
Start Printed Page 851
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 1993Do.Do.Do.
Letter to regulated industry notifying interested parties about important detailed information regarding labeling, scale-up, packaging, minor/major amendment criteria, and bioequivalence requirementsAugust 1993Do.Do.Do.
Major, Minor, and Telephone Amendments to Abbreviated New Drug ApplicationsDecember 2001Do.Do.Do.
Organization of an ANDAMarch 2, 1999Do.Do.Do.
Revising ANDA Labeling Following Revision of the RLD LabelingMay 2000Do.Do.Do.
Skin Irritation and Sensitization Testing of Generic Transdermal Drug ProductsFebruary 3, 2000Do.Do.Do.
Variations in Drug Products that May Be Included in a Single ANDADecember 1998Do.Do.Do.
ANDAs: Impurities in Drug ProductsJanuary 5, 1999Generics draftDo.Do.
Handling and Retention of Bioavailability and Bioequivalence Testing SamplesMay 26, 2004Do.Do.Do.
Potassium Chloride Modified-Release Tablets and Capsules: In Vivo Bioequivalence and In Vitro Dissolution Testing (revised)August 7, 2002Do.Do.Do.
Pharmacology/Toxicology Review FormatMay 2001Good review practices (GRP)Do.Do.
Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the ReviewNovember 22, 1996GRP draftDo.Do.
Good Review Management Principles for Prescription Drug User Fee Act ProductsJuly 28, 2003Do.Do.Do.
E10—Choice of Control Group and Related Issues in Clinical TrialsMay 14, 2001ICH, efficacyDo.Do.
E11—Clinical Investigation of Medicinal Products in the Pediatric PopulationDecember 15, 2000Do.Do.Do.
E1A—The Extent of Population Exposure to Assess Clinical Safety: for Drugs Intended for Long-Term Treatment of Non-Life-Threatening ConditionsMarch 1995Do.Do.Do.
E2A—Clinical Safety Data Management: Definitions and Standards for Expedited ReportingMarch 1995Do.Do.Do.
E2B—Data Elements for Transmission of Individual Case Safety ReportsJanuary 15, 1998Do.Do.Do.
E2BM—Data Elements for Transmission of Individual Case Safety Reports (revised)April 3, 2002Do.Do.Do.
E2BM—Data Elements for Transmission of Individual Case Safety Reports—Questions and AnswersMay 2004Do.Do.Do.
E2C—Clinical Safety Data Management: Periodic Safety Update Reports for Marketed DrugsMay 19, 1997Do.Do.Do.
Start Printed Page 852
E2C Addendum—Clinical Safety Data Management: Periodic Safety Update Reports for Marketed DrugsFebruary 5, 2004Do.Do.Do.
E3—Structure and Content of Clinical Study ReportsJuly 1996Do.Do.Do.
E4—Dose-Response Information to Support Drug RegistrationNovember 1994Do.Do.Do.
E5—Ethnic Factors in the Acceptability of Foreign Clinical DataJune 1998Do.Do.Do.
E6—Good Clinical Practice: Consolidated GuidelineMay 9, 1997Do.Do.Do.
E7—Studies in Support of Special Populations: GeriatricsAugust 1994Do.Do.Do.
E8—General Considerations for Clinical TrialsDecember 24, 1997Do.Do.Do.
E9—Statistical Principles for Clinical TrialsSeptember 1998Do.Do.Do.
M2 eCTD: Electronic Common Technical Document SpecificationApril 2, 2003ICH, joint safety/efficacy (multidisciplinary)Do.Do.
M3—Nonclinical Safety Studies for the Conduct of Human Clinical Trials for PharmaceuticalsNovember 25, 1997Do.Do.Do.
M4—Organization of the CTDAugust 2004Do.Do.Do.
M4—The CTD—Efficacy Questions and AnswersMay 2004Do.Do.Do.
M4—The CTD—General Questions and AnswersMay 2004Do.Do.Do.
M4—The CTD—Safety Questions and AnswersFebruary 4, 2003Do.Do.Do.
Q1A(R2)—Stability Testing of New Drug Substances and ProductsNovember 21, 2003ICH, qualityDo.Do.
Q1B—Photostability Testing of New Drug Substances and ProductsNovember 1996Do.Do.Do.
Q1C—Stability Testing for New Dosage FormsMay 9, 1997Do.Do.Do.
Q1D—Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and ProductsJanuary 16, 2003Do.Do.Do.
Q1F—Stability Data Package for the Registration in Climatic Zones III and IVJune 2004Do.Do.Do.
Q2A—Text on Validation of Analytical ProceduresMarch 1995Do.Do.Do.
Q2B—Validation of Analytical Procedures: MethodologyMay 19, 1997Do.Do.Do.
Q3A—Impurities in New Drug SubstancesFebruary 2003Do.Do.Do.
Q3B(R)—Impurities in Drug ProductsNovember 14, 2003Do.Do.Do.
Q3C—Impurities: Residual SolventsDecember 24, 1997Do.Do.Do.
Q3C—Tables and List (revised recommendations for N-Methylpyrrolidone and Tetrahydrofuran)November 2003Do.Do.Do.
Q5A—Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal OriginSeptember 24, 1998Do.Do.Do.
Start Printed Page 853
Q5B—Quality of Biotechnology Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein ProductsFebruary 1996Do.Do.Do.
Q5C—Quality of Biotechnological Products: Stability Testing of Biotechnology/Biological ProductsJuly 1996Do.Do.Do.
Q5D—Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological ProductsSeptember 21, 1998Do.Do.Do.
Q6A—Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical SubstancesDecember 29, 2000Do.Do.Do.
Q6B—Test Procedures and Acceptance Criteria for Biotechnological/Biological ProductsAugust 18, 1999Do.Do.Do.
Q7A—Good Manufacturing Practice for Active Pharmaceutical IngredientsAugust 2001Do.Do.Do.
S1A—The Need for Long-Term Rodent Carcinogenicity Studies of PharmaceuticalsMarch 1996ICH, safetyDo.Do.
S1B—Testing for Carcinogenicity of PharmaceuticalsJuly 1997Do.Do.Do.
S1C—Dose Selection for Carcinogenicity Studies of PharmaceuticalsMarch 1995Do.Do.Do.
S1C(R)—Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on a Limit Dose and Related NotesDecember 4, 1997Do.Do.Do.
S2A—Specific Aspects of Regulatory Genotoxicity Tests for PharmaceuticalsApril 1996Do.Do.Do.
S2B—Genotoxicity: A Standard Battery for Genotoxicity Testing of PharmaceuticalsNovember 21, 1997Do.Do.Do.
S3A—Toxicokinetics: The Assessment of Systemic Exposure in Toxicity StudiesMarch 1995Do.Do.Do.
S3B—Pharmacokinetics: Repeated Dose Tissue Distribution StudiesMarch 1995Do.Do.Do.
S4A—Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing)June 25, 1999Do.Do.Do.
S5A—Detection of Toxicity to Reproduction for Medicinal ProductsSeptember 22, 1994Do.Do.Do.
S5B—Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male FertilityApril 1996Do.Do.Do.
S6—Preclinical Safety Evaluation of Biotechnology-Derived PharmaceuticalsNovember 18, 1997Do.Do.Do.
S7A—Safety Pharmacology Studies for Human PharmaceuticalsJuly 13, 2001Do.Do.Do.
E2D—Postapproval Safety Data Management: Definitions and Standards for Expedited ReportingJuly 2003ICH draft, efficacyDo.Do.
E12A—Principles for Clinical Evaluation of New Antihypertensive DrugsAugust 9, 2000Do.Do.Do.
Start Printed Page 854
M4—Common Technical Document—Quality: Questions and Answers/Location IssuesDecember 30, 2002ICH draft, joint safety/efficacy (multidisciplinary)Do.Do.
Submitting Marketing Appilcations According to the ICH-CTD Format—General ConsiderationsSeptember 5, 2001Do.Do.Do.
Q1E—Evaluation of Stability DataJune 14, 2002ICH draft, qualityDo.Do.
S7B—The Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human PharmaceuticalsJune 2004ICH draft, safetyDo.Do.
Content and Format of INDs for Phase 1 Studies of Drugs; Including Well-Characterized, Therapeutic, Biotechnology-Derived ProductsNovember 1995INDDo.Do.
A Revision in Sample Collection Under the Compliance Program Pertaining to Preapproval InspectionsJuly 15, 1996Industry lettersDo.N/A
Continuation of a series of letters communicating interim and informal generic drug policy and guidance. Availability of Policy and Procedure Guides, and further operational changes to the generic drug review programMarch 2, 1998Do.Do.http://www.fda.gov/​cder/​guidance/​index.htm
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 1987Do.Do.Do.
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 1986Do.Do.Do.
Implementation of the Drug Price Competition and Patent Term Restoration Act. Preliminary GuidanceOctober 1984Do.Do.Do.
Implementation Plan USP injection nomenclatureOctober 1995Do.Do.Do.
Instructions for Filing Supplements Under the Provisions of SUPAC-IRApril 11, 1996Do.Do.N/A
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&C ActJuly 1988Do.Do.http://www.fda.gov/​cder/​guidance/​index.htm
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 1988Do.Do.Do.
Streamlining InitiativesDecember 24, 1996Do.Do.N/A
Supplement to 10/11/84 letter about policies, procedures and implementation of the Act (Q & A format)November 1984Do.Do.http://www.fda.gov/​cder/​guidance/​index.htm
Third of a series of letters regarding the implementation of the ActMay 1985Do.Do.Do.
Year 2000 Letter from Dr. Janet WoodcockOctober 19, 1998Do.Do.Do.
Barbiturate, Single Entity-Class LabelingMarch 1, 1981LabelingDo.N/A
Start Printed Page 855
Content and Format for Geriatric LabelingOctober 5, 2001Do.Do.http://www.fda.gov/​cder/​guidance/​index.htm
Hypoglycemic Oral AgentsApril 1, 1984Do.Do.N/A
Labeling Over-the-Counter Human Drug Products; Updating Labeling in Reference Listed Drugs and Abbreviated New Drug ApplicationsOctober 18, 2002Do.Do.http://www.fda.gov/​cder/​guidance/​index.htm
Local Anesthetics—Class LabelingSeptember 1, 1982Do.Do.N/A
Clinical Studies Section of Labeling for Prescription Drugs and Biologics—Content and FormatJuly 9, 2001Labeling draftDo.http://www.fda.gov/​cder/​guidance/​index.htm
Content and Format of the Adverse Reactions Section of Labeling for Human Prescription Drugs and BiologicsMarch 5, 2004Do.Do.Do.
Labeling for Combined Oral ContraceptivesMarch 2004Do.Do.Do.
Labeling for Noncontraceptive Estrogen Drug Products for the Treatment of Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms—Prescribing Information for Health Care Providers and Patient LabelingFebruary 2004Do.Do.Do.
OTC Topical Drug Products for the Treatment of Vaginal Yeast Infections (Vulvovaginal Candidiasis)June 1998Do.Do.Do.
Referencing Discontinued Labeling for Listed Drugs in Abbreviated New Drug ApplicationsOctober 26, 2000Do.Do.Do.
Enforcement Policy on Marketing OTC Combination Products (CPG 7132b.16)May 1984OTCDo.Do.
General Guidelines for OTC Combination ProductsSeptember 1978Do.Do.Do.
Labeling OTC Human Drug Products Using a Column FormatDecember 19, 2000Do.Do.Do.
Upgrading Category III Antiperspirants to Category I (43 FR 46728-46731)October 1978Do.Do.Do.
Labeling OTC Human Drug Products—Submitting Requests for Exemptions and DeferralsDecember 19, 2000OTC draftDo.Do.
Labeling OTC Human Drug Products Updating Labeling in ANDAsFebruary 2001Do.Do.Do.
OTC Actual Use StudiesJuly 22, 1994Do.Do.N/A
OTC Nicotine SubstitutesMarch 1, 1994Do.Do.Do.
Time and Extent ApplicationsFebruary 10, 2004Do.Do.http://www.fda.gov/​cder/​guidance/​index.htm
Carcinogenicity Study Protocol SubmissionsMay 2002Pharmacology/ToxicologyDo.Do.
Format and Content of the Nonclinical Pharmacology/Toxicology Section of an ApplicationFebruary 1987Do.Do.Do.
Immunotoxicology Evaluation of Investigational New DrugsOctober 2002Do.Do.Do.
Start Printed Page 856
Nonclinical Pharmacology/Toxicology Development of Topical Drugs Intended to Prevent the Transmission of Sexually Transmitted Diseases (STD) and/or for the Development of Drugs Intended to Act as Vaginal ContraceptivesOctober 1996Do.Do.Do.
Photosafety TestingMay 7, 2003Do.Do.Do.
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 1989Do.Do.Do.
Single Dose Acute Toxicity Testing for PharmaceuticalsAugust 1996Do.Do.Do.
Estimating the Safe Starting Dose in Clinical Trials for Therapeutics in Adult Healthy VolunteersJanuary 16, 2003Pharmacology/Toxicology draftDo.Do.
Integration of Study Results to Access Concerns About Human Reproductive and Developmental ToxicitiesNovember 13, 2001Do.Do.Do.
Nonclinical Safety Evaluation of Pediatric Drug ProductsFebruary 2003Do.Do.Do.
Nonclinical Studies for Development of Pharmaceutical ExcipientsOctober 2, 2002Do.Do.Do.
Statistical Aspects of the Design, Analysis, and Interpretation of Chronic Rodent Carcinogenicity Studies of PharmaceuticalsMay 8, 2001Do.Do.Do.
180-Day Generic Drug Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic ActJune 1998ProceduralDo.Do.
Continuous Marketing Applications: Pilot 1—Reviewable Units for Fast Track Products Under the PDUFAOctober 2003Do.Do.Do.
Continuous Marketing Applications: Pilot 2—Scientific Feedback and Interactions During Drug Development of Fast Track Products Under the PDUFAOctober 2003Do.Do.Do.
Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic ActMarch 27, 2000Do.Do.Do.
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, 1999Do.Do.Do.
Drug Products Containing Ensulizole, Hypromellose, Meradimate, Octinoxate, and Octisalate—Labeling Enforcement PolicyJune 3, 2003Do.Do.Do.
Enforcement Policy During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic ActNovember 23, 1998Do.Do.Do.
Fast Track Drug Development Programs—Designation, Development, and Application ReviewJuly 2004Do.Do.Do.
Financial Disclosure by Clinical InvestigatorsMarch 2001Do.Do.Do.
Formal Dispute Resolution: Appeals Above the Division LevelFebruary 2000Do.Do.Do.
Start Printed Page 857
Formal Meetings With Sponsors and Applicants For PDUFA ProductsFebruary 2003Do.Do.Do.
Implementation of Section 120 of the Food and Drug Administration Modernization Act of 1997—Advisory CommitteesNovember 2, 1998Do.Do.Do.
Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997—Elimination of Certain Labeling RequirementsJuly 21, 1998Do.Do.Do.
Information Program on Clinical Trials for Serious or Life-Threatening Diseases and ConditionsJanuary 27, 2004Do.Do.Do.
Potassium Iodide in Radiation Emergencies—Questions and AnswersDecember 23, 2002Do.Do.Do.
Potassium Iodide Tablets for Shelf Life Extension for Federal Agencies and State and Local GovernmentsMarch 8, 2004Do.Do.Do.
Levothyroxine Sodium Products Enforcement of August 14, 2001, Compliance Date and Submission of New ApplicationsJuly 13, 2001Do.Do.Do.
National Uniformity for Nonprescription Drugs—Ingredient Listing for OTC DrugsApril 9, 1998Do.Do.Do.
Potassium Iodide as a Thyroid Blocking Agent in Radiation EmergenciesDecember 11, 2001Do.Do.Do.
Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act (revised)September 1999Do.Do.Do.
Refusal to FileJuly 12, 1993Do.Do.Do.
Repeal of Section 507 of the Federal Food, Drug, and Cosmetic ActMay 1998Do.Do.Do.
Special Protocol AssessmentMay 17, 2002Do.Do.Do.
Standards for the Prompt Review of Efficacy Supplements, Including Priority Efficacy SupplementsMay 15, 1998Do.Do.Do.
Guidance for FDA Staff: The Leveraging Handbook; an Agency Resource for Effective CollaborationsJune 19, 2003Do.Do.Do.
Women and Minorities Guidance RequirementsJuly 20, 1998Do.Do.Do.
Applications Covered by Section 505(b)(2)October 1999Procedural draftDo.Do.
Clinical Trial Sponsors On the Establishment and Operation of Clinical Trial Data Monitoring CommitteesNovember 2001Do.Do.Do.
PET Drug Applications—Content and Format for NDAs and ANDAsMarch 2000Do.Do.Do.
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, 1999Do.Do.Do.
Disclosure of Conflicts of Interest for Special Government Employees Participating in FDA Product Specific Advisory CommitteesFebruary 14, 2002Do.Do.Do.
Start Printed Page 858
Forms for Registration of Producers of Drugs and Listing of Drugs in Commercial DistributionApril 2001Do.Do.Do.
Good Review Management Principles for PDUFA ProductsJuly 28, 2003Do.Do.Do.
Independent Consultants for Biotechnology Clinical Trial ProtocolsMay 7, 2003Do.Do.Do.
Information Program on Clinical Trials for Serious or Life-Threatening Diseases and ConditionsJanuary 27, 2004Do.Do.Do.
Pharmacogenomic Data SubmissionsJanuary 27, 2004Do.Do.Do.
Postmarketing Safety Reporting for Human Drug and Biological Products Including VaccinesMarch 12, 2001Do.Do.Do.
Reports on the Status of Postmarketing Studies—Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997April 4, 2001Do.Do.Do.
Submitting Debarment Certification StatementsOctober 2, 1998Do.Do.Do.
Submitting Marketing Applications According to the ICH/CTD Format—General ConsiderationsSeptember 5, 2001Do.Do.Do.
The Use of Clinical Holds Following Clinical Investigator MisconductApril 2002Do.Do.Do.
Sterility Requirements for Aqueous-Based Drug Products for Oral Inhalation—Small Entity Compliance GuideNovember 7, 2001Small entity compliance guidesDo.Do.
Applicability of User Fees to (1) Applications Withdrawn Before Filing, or (2) Applications the Agency Has Refused to File and That Are Resubmitted or Filed Over Protest (Attachment F)July 12, 1993User feeDo.Do.
Application, Product, and Establishment Fees: Common Issues and Their Resolution (revised) (attachment D) (I)December 16, 1994Do.Do.Do.
Classifying Resubmissions in Response to Action LettersMay 14, 1998Do.Do.Do.
Fees-Exceed-the-Costs Waivers Under the Prescription Drug User Fee ActJune 1999Do.Do.Do.
Information Request and Discipline Review Letters Under the Prescription Drug User Fee ActNovember 21, 2001Do.Do.Do.
Submitting and Reviewing Complete Responses to Clinical Holds (revised)October 26, 2000Do.Do.Do.
Document for Waivers of and Reductions in User Fees (attachment G)July 16, 1993User fees draftDo.Do.
Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User FeesDecember 2000Do.Do.Do.
WITHDRAWALS
In Vivo Bioequivalence Studies on Population and Individual Bioequivalence StudiesDecember 30, 1987Do.Do.
Clinical Evaluation of Antacid DrugsApril 1, 1978N/AN/A
Clinical Evaluation of Antidiarrheal DrugsSeptember 1, 1977Do.Do.
Start Printed Page 859
Clinical Evaluation of Gastric Secretory Depressant (GSD) DrugsSeptember 1, 1977Do.Do.
Clinical Evaluation of Laxative DrugsApril 1, 1978Do.Do.
Clinical Evaluation of Radiopharmaceutical DrugsOctober 1, 1981Do.Do.
FDA Requirements for Approval of Drugs to Treat Superficial Bladder CancerJune 20, 1989Do.Do.
ANDAs: Blend Uniformity AnalysisAugust 27, 1999Do.Do.
Topical Dermatological Drug Products NDAs and ANDAs—In Vivo Bioavailability, Bioequivalence, In Vitro Release, and Associated StudiesJune 18, 1998Do.Do.
Clinical Evaluation of Combination Estrogen/Progestin-Containing Drug Products Used for Hormone Replacement Therapy of Postmenopausal WomenMarch 1, 1995Do.Do.
Noncontraceptive Estrogen Drug Products—Prescribing Information for Healthcare Providers and Patient LabelingSeptember 27, 1999Do.Do.
Chlordiazepoxide Hydrochloride CapsulesJanuary 1, 1988Do.Do.
Clorazepate Dipotassium Capsules/TabletsMarch 1, 1993Do.Do.
Cyproheptadine Hydrochloride Tablets/SyrupDecember 1, 1986Do.Do.
Dipivefrin Hydrochloride Ophthalmic Solution, 0.1%November 2, 1998Do.Do.
Ergoloid Mesylate TabletsJanuary 1, 1988Do.Do.
Hydroxyzine Hydrochloride InjectionDecember 1, 1989Do.Do.
Isoetharine Inhalation SolutionMarch 1, 1989Do.Do.
Meclofenamate Sodium CapsulesJuly 1, 1992Do.Do.
Naphazoline Hydrochloride Ophthalmic SolutionMarch 1, 1989Do.Do.
Niacin TabletsJuly 1, 1992Do.Do.
Phendimetrazine Tartrate Capsules/Tablets and Extended-Release CapsulesFebruary 1, 1991Do.Do.
Phentermine Hydrochloride Capsules/TabletsAugust 1, 1988Do.Do.
Promethazine Hydrochloride TabletsMarch 1, 1990Do.Do.
Propantheline Bromide TabletsAugust 1, 1988Do.Do.
Pyridoxine Hydrochloride InjectionJune 1, 1984Do.Do.
Quinidine Sulfate Capsules USPOctober 1, 1995Do.Do.
Sulfamethoxazole and Phenazopyridine Hydrochloride TabletsFebruary 1, 1992Do.Do.
Theophylline Immediate Release Oral Dosage FormsFebruary 1, 1995Do.Do.
Thiamine Hydrochloride InjectionFebruary 1, 1988Do.Do.
Vitamin A CapsulesFebruary 1, 1992Do.Do.
Part 11; Electronic Records; Electronic Signatures, Electronic Copies of Electronic RecordsNovember 12, 2002Do.Do.
Start Printed Page 860
Clinical Evaluation of Analgesic DrugsDecember 1, 1992Do.Do.
Using FDA-Approved Patient Labeling in Consumer-Directed Print AdvertisementsApril 23, 2001Do.Do.

Guidance Documents Issued by CDRH

Name of DocumentDate of IssuanceIntended User or Regulatory ActivityHow to Obtain a Copy of the Document
Guidance for Industry, FDA Staff, and Third Parties; Implementation of the Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002; Accreditation CriteriaOctober 4, 2004FDA, regulated industry, and third partiesDivision of Small Manufacturers, International and Consumer Assistance, 1-800-638-2041 or 301-443-6597; or Facts-on-Demand,1 301-827-0111; or Internet at http://www.fda.gov/​cdrh/​ guidance.html
Implementation of Third Party Programs Under the FDA Modernization Act of 1997; Final Guidance for Staff, Industry, and Third PartiesFebruary 2, 2001Do.Do.
Mutual Recognition Agreement Between the European Union and the United States of America: Confidence Building Programme: Overview and Procedure; Medical Device Annex, Version 7, June 29, 2000; DraftJune 29, 2000FDA and regulated industryDo.
Draft Guidance for Industry and FDA; Medical Glove Guidance ManualJuly 30, 1999Do.Do.
Guidance for Industry and FDA; Regulation of Medical Devices; Background Information for International Officials (entire document available on disk)April 14, 1999Do.Do.
Guidance for Staff, Industry, and Third Parties; 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)January 6, 1999Do.Do.
Medical Device Appeals and Complaints: Guidance on Dispute ResolutionFebruary 1998Do.Do.
Overview of FDA Modernization Act of 1997 Medical Device ProvisionsFebruary 19, 1998Do.Do.
Medical Device Reporting for ManufacturersMarch 1997Do.Do.
In Vitro Diagnostic Devices: Guidance for the Preparation of 510(k) Submissions (FDA 97-4224)January 1997Do.Do.
Medical Device Quality Systems Manual: A Small Entity Compliance GuideApril 14, 1999Do.Do.
Comparison Chart: 1996 Quality System Regulation vs. 1978 Good Manufacturing Practices Regulation vs. ANSI/ISO/ASQC Q9001-1994 and ISO/DIS 13485:1996November 29, 1996Do.Do.
Premarket Notification: 510(k)—Regulatory Requirements for Medical Devices (FDA 95-4158)August 1995Do.Do.
Start Printed Page 861
Labeling—Regulatory Requirements for Medical DevicesSeptember 1, 1989Do.Do.
Impact Resistant Lenses: Questions and Answers (FDA 87-4002)September 1987Do.Do.
CDRH Manual for the GGP Regulations; Final Guidance for FDA StaffFebruary 9, 2001FDADo.
Human Factors Principles for Medical Device LabelingSeptember 1, 1993FDA, regulated industryDo.
Human Factors PTC for IDE DevicesJanuary 17, 1997Do.Do.
Write It RightAugust 1993Do.Do.
Do It By Design—An Introduction to Human Factors in Medical DevicesDecember 1996Do.Do.
Guidance for Industry and FDA Premarket and Design Control Reviewers; Medical Device Use—Safety: Incorporating Human Factors Engineering into Risk ManagementJuly 18, 2000Do.Do.
Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA ReviewersApril 19, 2001Do.Do.
Medical Device Reporting for User FacilitiesApril 1996FDA and user facilitiesDo.
Frequently-Asked Questions About the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors; Final Guidance for Industry and FDA StaffJuly 6, 2001FDA, regulated industry, third party, and hospital reprocessorsDo.
Frequently-Asked Questions About the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors; Three Additional QuestionsJuly 16, 2003Do.Do.
Continuing Education Credit for Reading/Writing Articles/Papers and Presenting Courses/Lectures (incorporated into the Policy Guidance Help System (PGHS))March 17, 1998FDA, accreditation bodies, and mammography facilitiesDo.
Guidance for Submission of Request for Reconsideration of Adverse Decisions on Accreditation of Mammography Facilities Under the Mammography Quality Standards Acts, 42 U.S.C. 263(b)/4/8, 1998 (incorporated into PGHS)March 26, 1998Do.Do.
Guidance for Review of Requests for Reconsideration of Adverse Decisions on Accreditation of Mammography Facilities Under the Mammography Quality Standards Act, 42 U.S.C. 263(b)/4/8, 1998 (incorporated into PGHS)March 26, 1998Do.Do.
Policy and Standard Operating Procedures When Mammography Facilities in States That Have Accreditation Bodies Intend to Change Accreditation Bodies (incorporated into PGHS)April 15, 1998Do.Do.
Guidance for Industry; Requalification for Interpreting Physician's Continuing Experience Requirement (incorporated into PGHS)May 28, 1998Do.Do.
Guidance; The Mammography Quality Standards Act Final Regulations; Document #1 (incorporated into PGHS)March 19, 1999Do.Do.
Start Printed Page 862
Compliance Guidance; The Mammography Quality Standards Act Final Regulations Motion of Tube-Image Receptor Assembly (incorporated into PGHS)March 23, 1999Do.Do.
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) (incorporated into PGHS)May 4, 1999Do.Do.
Compliance Guidance; The Mammography Quality Standards Act Final Regulations Quality Assurance Documentation (incorporated into PGHS)December 7, 1999Do.Do.
Compliance Guidance; The Mammography Quality Standards Act Final Regulations; Document #2 (incorporated into PGHS)February 25, 2000Do.Do.
The Mammography Quality Standards Act Final Regulations Modifications to the Policy Guidance Help System #1; Guidance for Industry and FDA (incorporated into PGHS)July 5, 2000Do.Do.
Compliance Guidance; The Mammography Quality Standards Act Final Regulations; Document #3 (incorporated into PGHS)July 18, 2000Do.Do.
Compliance Guidance; Mammography Facility Survey, Equipment Evaluation, and Medical Physicist Qualification Requirements Under MQSA; Final (incorporated into PGHS)November 6, 2000Do.Do.
The Mammography Quality Standards Act Final Regulations; Modifications and Additions to Policy Guidance Help System #2; Final Guidance for Industry and FDA (incorporated into PGHS)January 24, 2001Do.Do.
The Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System #4; Guidance for Industry and FDA (incorporated into PGHS)May 23, 2001Do.Do.
The Mammography Quality Standards Act Final Regulations Modifications to the Policy Guidance Help System Due to the September 11, 2002, Terrorist Attacks; Final Guidance for Industry and FDA (incorporated into PGHS)October 5, 2001Do.Do.
The Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System #3; Guidance for Industry and FDA (incorporated into PGHS)November 5, 2001Do.Do.
Compliance Guidance; The Mammography Quality Standards Act Final Regulations—Preparing for MQSA Inspections (incorporated into PGHS)November 5, 2001Do.Do.
The Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System #4; Guidance for Industry and FDA (incorporated into PGHS)March 25, 2002Do.Do.
The Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System #5; Guidance for Industry and FDA (incorporated into PGHS)July 8, 2002Do.Do.
Start Printed Page 863
The Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System #7; Guidance for Industry and FDA (incorporated into PGHS)January 28, 2003Do.Do.
The Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System #6 (incorporated into PGHS)August 19, 2003Do.Do.
Accidental Radioactive Contamination of Human Food and Animal Feeds: Recommendations to State and Local AgenciesAugust 13, 1998FDA, State and local agenciesDo.
Office of Device Evaluation
FY 2004 MDUFMA Small Business Qualification Worksheet and Certification; Guidance for Industry and FDAAugust 1, 2003Office of Device EvaluationDo.
Premarket Assessment of Pediatric Medical Devices; Draft Guidance for Industry and FDA StaffJuly 24, 2003Do.Do.
Pediatric Expertise for Advisory Panels; Guidance for Industry and FDA StaffJune 3, 2003Do.Do.
Premarket Approval Application Filing Review; Guidance for Industry and FDA StaffMay 1, 2003Do.Do.
Guidance for Industry and FDA; FY 2003 MDUFMA Small Business Qualification Worksheet and CertificationMarch 27, 2003Do.Do.
Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination ProductsFebruary 21, 2003Do.Do.
Determination of Intended Use for 510(k) Devices; Guidance for CDRH StaffDecember 3, 2002Do.Do.
The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles; Final Guidance for FDA and IndustryOctober 4, 2002Do.Do.
Medical Devices Made With Polyvinylchloride (PVC) Using the Plasticizer di-(2-Ethylhexyl)phthalate (DEHP); Draft Guidance for Industry and FDASeptember 6, 2002Do.Do.
Updated 510(k) Sterility Review Guidance K90-1; Final Guidance for Industry and FDAAugust 30, 2002Do.Do.
Availability of Information Given to Advisory Committee Members in Connection With CDRH Open Public Panel Meetings; Draft Guidance for Industry and FDA StaffJuly 18, 2001Do.Do.
Humanitarian Device Exemptions (HDE) Regulation: Questions and Answers; Final Guidance for IndustryJuly 12, 2001Do.Do.
Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH StaffMay 29, 2001Do.Do.
Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Final Guidance for Industry and for CDRH StaffFebruary 28, 2001Do.Do.
Start Printed Page 864
Deciding When To Submit a 510(k) for a Change to an Existing Wireless Telemetry Medical Device; Final Guidance for FDA Reviewers and IndustryNovember 30, 2000Do.Do.
Guidance on Section 216 of the Food and Drug Administration Modernization Act of 1997August 9, 2000Do.Do.
Guidance on Amended Procedures for Advisory Panel Meetings; FinalJuly 22, 2000Do.Do.
Guidance on the Use of Standards in Substantial Equivalence Determinations; FinalMarch 12, 2000Do.Do.
Guidance for Off-the-Shelf Software Use in Medical Devices; FinalSeptember 9, 1999Do.Do.
Draft Guidance on Evidence Models for the Least Burdensome Means to MarketSeptember 1, 1999Do.Do.
Medical Devices Containing Materials Derived from Animal Sources (Except In Vitro Diagnostic Devices); Final Guidance for FDA Reviewers and IndustryNovember 16, 1998Do.Do.
Guidance for the Medical Device Industry on PMA Shell Development and Modular Review; FinalNovember 6, 1998Do.Do.
Guidance for Industry; General/Specific Intended Use; FinalNovember 4, 1998Do.Do.
Frequently Asked Questions on the New 510(k) Paradigm; FinalOctober 22, 1998Do.Do.
Modifications to Devices Subject to Premarket Approval—The PMA Supplement Decision Making Process; DraftAugust 6, 1998Do.Do.
Guidance for Industry; Contents of a Product Development Protocol; DraftJuly 27, 1998Do.Do.
New Model Medical Device Development Process; FinalJuly 21, 1998Do.Do.
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices; FinalMay 29, 1998Do.Do.
Guidance to Industry Supplements to Approved Applications for Class III Medical Devices: Use of Published Literature, Use of Previously Submitted Materials, and Priority Review; FinalMay 20, 1998Do.Do.
A New 510(k) Paradigm—Alternate Approaches to Demonstrating Substantial Equivalence in Premarket NotificationsMarch 20, 1998Do.Do.
PMA/510(k) Expedited Review; Guidance for Industry and CDRH Staff; FinalMarch 20, 1998Do.Do.
PMA/510(k) Expedited Review G94-4 (blue book memo)March 20, 1998Do.Do.
30-Day Notices and 135-Day PMA Supplements for Manufacturing Method or Process Changes; Guidance for Industry and CDRH (Docket No. 98D-0080); FinalFebruary 19, 1998Do.Do.
Guidance on PMA Interactive Procedures for Day-100 Meetings and Subsequent Deficiencies—for Use by CDRH and Industry; FinalFebruary 19, 1998Do.Do.
Start Printed Page 865
New section 513(f)(2)—Evaluation of Automatic Class III Designation; Guidance for Industry and CDRH Staff; FinalFebruary 19, 1998Do.Do.
Procedures for Class II Device Exemptions from Premarket Notification Guidance for Industry and CDRH Staff; FinalFebruary 19, 1998Do.Do.
Guidance on IDE Policies and Procedures; FinalJanuary 20, 1998Do.Do.
Distribution and Public Availability of PMA Summary of Safety and Effectiveness Data PackagesOctober 10, 1997Do.Do.
Kit Certification for 510(k)sJuly 1, 1997Do.Do.
Convenience Kits Interim Regulatory GuidanceMay 20, 1997Do.Do.
Real-Time Review Program for Premarket Aproval Application (PMA) SupplementsApril 22, 1997Do.Do.
Deciding When to Submit a 510(k) for a Change to an Existing Device (K97-1)January 10, 1997Do.Do.
Questions and Answers for the FDA Reviewer Guidance: Labeling Reusable Medical Devices for Reprocessing in Health Care FacilitiesSeptember 3, 1996Do.Do.
Memorandum of Understanding Regarding Patient Labeling Review (blue book memo #G96-3)August 9, 1996Do.Do.
Continued Access to Investigational Devices During PMA Preparation and Review (blue book memo #D96-1)July 15, 1996Do.Do.
Document Review by the Office of the Chief Counsel (blue book memo G96-1)June 6, 1996Do.Do.
Format for IDE Progress ReportsJune 1, 1996Do.Do.
Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer GuidanceApril 1, 1996Do.Do.
510(k) Quality Review Program (blue book memo)March 29, 1996Do.Do.
Suggested Content for Original IDE Application Cover LetterFebruary 27, 1996Do.Do.
Indications for Use StatementJanuary 2, 1996Do.Do.
Letter—Vascular Graft Industry (Philip Phillips)November 22, 1995Do.Do.
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, 1995Do.Do.
Color Additives for Medical Devices (Snesko)November 15, 1995Do.Do.
#D95-2, Attachment A (Interagency Agreement between FDA and HCFA)September 15, 1995Do.Do.
#D95-2, Attachment B (Criteria for Categorization of Investigational Devices (HCFA))September 15, 1995Do.Do.
Start Printed Page 866
HCFA Reimbursement Categorization Determinations for FDA-Approved IDEsSeptember 15, 1995Do.Do.
Implementation of the FDA/HCFA Interagency Agreement Regarding Reimbursement Categorization of Investigational Devices, Attachment A Interagency Agreement, Attachment B Criteria for Catergorization of Investigational Devices, and Attachment C—List (blue book memo #D95-2)September 15, 1995Do.Do.
Goals and Initiatives for the IDE Program (blue book memo #D95-1)July 12, 1995Do.Do.
Memorandum: Electromagnetic Compatibility for Medical Devices: Issues and SolutionsJune 13, 1995Do.Do.
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, 1995Do.Do.
Premarket Approval Application (PMA) Closure (blue book memo #P94-2)July 8, 1994Do.Do.
510(k) Sign-Off Procedures (blue book memo #K94-2)June 3, 1994Do.Do.
Letter to Industry, Powered Wheelchair/Scooter or Accessory/Component Manufacturer from Susan Alpert, Ph.D., M.D.May 26, 1994Do.Do.
510(k) Refuse to Accept Procedures (blue book memo #K94-1)May 20, 1994Do.Do.
IDE Refuse to Accept Procedures (blue book memo #D94-1)May 20, 1994Do.Do.
PMA/510(k) Triage Review Procedures (blue book memo #G94-1)May 20, 1994Do.Do.
Preamendments Class III StrategyApril 19, 1994Do.Do.
Premarket Notification (510(k)) Status Request FormMarch 7, 1994Do.Do.
Documentation and Resolution of Differences of Opinion on Product Evaluations (blue book memo #G93-1)December 23, 1993Do.Do.
510(k) Additional Information Procedures (blue book memo #K93-1)July 23, 1993Do.Do.
CDRH's Investigational Device Exemption (IDE) Refuse to Accept PolicyJune 30, 1993Do.Do.
CDRH's Premarket Notification (510(k)) Refuse to Accept Policy (updated checklist March 14, 1995)June 30, 1993Do.Do.
Proposal for Establishing Mechanisms for Setting Review Priorities Using Risk Assesment and Allocating Review ResourcesJune 30, 1993Do.Do.
Classified Convenience KitsApril 30, 1993Do.Do.
Telephone Communications Between ODE Staff and Manufacturers (blue book memo #I93-1)January 29, 1993Do.Do.
Preamendment Class III DevicesMarch 11, 1992Do.Do.
Nondisclosure of Financially Sensitive Information (blue book memo #I92-1)March 5, 1992Do.Do.
Start Printed Page 867
Document Review Processing (blue book memo #I91-1)February 12, 1992Do.Do.
4-of-a-Kind PMAsOctober 1, 1991Do.Do.
Review of 510(k)s for Computer Controlled Medical Devices (blue book memo #K91-1)August 29, 1991Do.Do.
Review of Final Draft Medical Device Labeling (blue book memo #P91-4)August 29, 1991Do.Do.
Integrity of Data and Information Submitted to ODE (blue book memo #I91-2)May 29, 1991Do.Do.
Clinical Utility and Premarket Approval (blue book memo #P91-1)May 3, 1991Do.Do.
Panel Review of Premarket Approval Applications (blue book memo #P91-2)May 3, 1991Do.Do.
PMA Compliance Program (blue book memo #P91-3)May 3, 1991Do.Do.
Shelf Life of Medical DevicesApril 1, 1991Do.Do.
Device Labeling Guidance (blue book memo #G91-1)March 8, 1991Do.Do.
Review and Approval of PMAs of Licensees (blue book memo #P86-4)October 22, 1990Do.Do.
Consolidated Review of Submissions for Diagnostic Ultrasound Equipment, Accessories and Related Measurement Devices (blue book memo #G90-2)October 19, 1990Do.Do.
Consolidated Review of Submissions for Lasers and Accessories (blue book memo #G90-1)October 19, 1990Do.Do.
Assignment of Review Documents (blue book memo #I90-2)August 24, 1990Do.Do.
PMA Supplements: ODEs Letter to Manufacturers; Identifies Situations Which May Require the Submission of a PMA Supplement (When PMA Supplements Are Required) (blue book memo #P90-1)April 24, 1990Do.Do.
Policy Development and Review Procedures (blue book memo #I90-1)February 15, 1990Do.Do.
Substantial Equivalence (SE) Decision Making Documentation Attached: “SE” Decision Making Process (detailed); i.e., The Decision Making TreeJanuary 1, 1990Do.Do.
Threshold Assessment of the Impact of Requirements for Submission of PMAs for 31 Medical Devices Marketed Prior to May 28, 1976January 1, 1990Do.Do.
Meetings with the Regulated Industry (blue book memo #I89-3)November 20, 1989Do.Do.
FDA Policy for The Regulation of Computer Products; DraftNovember 13, 1989Do.Do.
Toxicology Risk Assessment Committee (blue book memo #G89-1)August 9, 1989Do.Do.
Review of IDEs for Feasibility Studies (blue book memo #D89-1)May 17, 1989Do.Do.
Start Printed Page 868
Premarket Notification—Consistency of Reviews (blue book memo #K89-1)February 28, 1989Do.Do.
Review of Laser Submissions (blue book memo #G88-1)April 15, 1988Do.Do.
PMA Review Schedules (P87-1); replaced by P94-2March 31, 1988Do.Do.
Guideline on Validation of the Limulus Amebocyte Lysate (LAL) Test as an End-Product Endotoxin TestDecember 1, 1987Do.Do.
Necessary Information for Diagnostic Ultrasound 510(k); DraftNovember 24, 1987Do.Do.
Limulus Amebocute Lysate; Reduction of Samples for TestingOctober 23, 1987Do.Do.
ODE Executive Secretary Guidance Manual G87-3August 7, 1987Do.Do.
Guideline on Sterile Drug Products Produced by Aseptic ProcessingJune 1, 1987Do.Do.
Master Files Part III; Guidance on Scientific and Technical InformationJune 1, 1987Do.Do.
ODE Regulatory Information for the Office of Compliance—Information Sharing Procedures (blue book memo #G87-2)May 15, 1987Do.Do.
Guideline on General Principles of Process ValidationMay 1, 1987Do.Do.
Industry Representatives on Scientific PanelMarch 27, 1987Do.Do.
Panel Review of “Me-Too” Devices (blue book memo #P86-6)July 1, 1986Do.Do.
Guidance on CDRH's Premarket Notification Review Program (blue book memo #K86-3)June 30, 1986Do.Do.
Panel Report and Recommendations on PMA Approvals (blue book memo #P86-5)April 18, 1986Do.Do.
Criteria for Panel Review of PMA Supplements (blue book memo #P86-3)January 30, 1986Do.Do.
PMAs—Early Review and Preparation of Summaries of Safety and Effectiveness (blue book memo #P86-1)January 27, 1986Do.Do.
PTC in the Characterization of Cell Lines Used to Produce Biological ProductsJune 1, 1984Do.Do.
Application of the Device Good Manufacturing Practice (GMP) Regulation to the Manufacture of Sterile DevicesDecember 1, 1983Do.Do.
Methods for Conducting Recall Effectiveness ChecksJune 16, 1978Do.Do.
Guidance for Submitting Reclassification Petition1997Do.Do.
Reprocessing and Reuse of Single-Use Devices: Review Prioritization Scheme; DraftFebruary 8, 2000Do.Do.
Class II Special Controls Guidance Document: Apnea Monitors; Guidance for Industry and FDAJuly 17, 2002Do.Do.
Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCo2) and Oxygen (PcO2) Monitors; Guidance for Industry and FDADecember 13, 2002Do.Do.
Start Printed Page 869
Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDAOctober 5, 2001Do.Do.
Heated Humidifier Review GuidanceAugust 30, 1991Do.Do.
Class II Special Controls Guidance Document: Optical Impression Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations; Guidance for Industry and FDAApril 22, 2003Do.Do.
Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDANovember 12, 2002Do.Do.
Class II Special Controls Guidance Document: Dental Sonography and Jaw Tracking Devices; Draft Guidance for Industry and FDA ReviewersAugust 14, 2002Do.Do.
Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Abutments; Draft Guidance for Industry and FDAMay 14, 2002Do.Do.
Special Control Guidance Document on Encapsulated Amalgam, Amalgam Alloy, and Dental Mercury Labeling; Draft Guidance for Industry and FDAFebruary 20, 2002Do.Do.
Overview of Information Necessary for Premarket Notification Submissions for Endosseous Implants; FinalApril 21, 1999Do.Do.
Guidance for the Preparation of Premarket Notifications for Dental CompositesNovember 27, 1998Do.Do.
Dental Cements—Premarket Notification; FinalAugust 18, 1998Do.Do.
Dental Impression Materials—Premarket Notification; FinalAugust 17, 1998Do.Do.
OTC Denture Cushions, Pads, Reliners, Repair Kits, and Partially Fabricated Denture Kits; FinalAugust 17, 1998Do.Do.
Draft Guidance Document for the Preparation of Premarket Notification 510(k)s for Dental AlloysMarch 3, 1997Do.Do.
Information Necessary for Premarket Notification Submissions for Screw-Type Endosseous ImplantsDecember 9, 1996Do.Do.
Guidance Document on Dental HandpiecesJuly 1, 1995Do.Do.
Guidance for the Arrangement and Content of a Premarket Approval (PMA) Application for an Endosseous Implant for Prosthetic AttachmentMay 16, 1989Do.Do.
Supplementary Guidance on Premarket Notifications for Medical Devices With Sharps Injury Prevention Features; Guidance for Industry and FDADecember 31, 2002Do.Do.
Guidance on Premarket Notifications for Intravascular Administration SetsOctober 12, 2000Do.Do.
Neonatal and Neonatal Transport Incubators—Premarket Notifications; FinalSeptember 18, 1998Do.Do.
Guidance on the Content of Premarket Notification (510(k)) Submissions for Protective RestraintsDecember 1, 1995Do.Do.
Start Printed Page 870
Guidance on Premarket Notification (510(k)) Submissions for Short-Term and Long-Term Intravascular CathetersMarch 16, 1995Do.Do.
Guidance on the Content of Premarket Notification (510(k)) Submissions for Hypodermic Single Lumen NeedlesApril 1, 1993Do.Do.
Guidance on the Content of Premarket Notification (510(k)) Submissions for Piston SyringesApril 1, 1993Do.Do.
Guidance on the Content of Premarket Notification (510(k)) Submissions for Clinical Electronic ThermometersMarch 1, 1993Do.Do.
Guidance on the Content of Premarket Notification (510(k)) Submissions for External Infusion PumpsMarch 1, 1993Do.Do.
Guidance on 510(k) Submissions for Implanted Infusion PortsOctober 1, 1990Do.Do.
Surgical Masks—Premarket Notification (510(k)) Submissions; Draft GuidanceMay 15, 2003Do.Do.
Regulatory Status of Disinfectants Used to Process Dialysate Delivery Systems and Water Purification Systems for Hemodialysis; Guidance for Industry and FDAAugust 30, 2002Do.Do.
Premarket Notification (510(k)) Submissions for Medical Sterilization Packaging Systems in Health Care Facilities; Draft Guidance for Industry and FDAMarch 7, 2002Do.Do.
Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors; Guidance for the Medical Device Industry and FDA Review StaffFebruary 7, 2002Do.Do.
Premarket Guidance: Reprocessing and Reuse of Single-Use Devices; Draft Guidance for Industry and FDA StaffJune 1, 2001Do.Do.
Premarket Notifications (510(k)) for Biological Indicators Intended to Monitor Sterilizers Used in Health Care Facilities; Draft Guidance for Industry and FDA ReviewersMay 21, 2001Do.Do.
Premarket Approval Applications (PMA) for Sharps Needle Destruction Devices; Final Guidance for Industry and FDAMarch 2, 2001Do.Do.
Guidance on the Content and Format of Premarket Notification (510(k)) Submissions for Liquid Chemical Sterilants and High Level Disinfectants; FinalJanuary 3, 2000Do.Do.
Guidance for Conducting Stability Testing to Support an Expiration Date Labeling Claim for Medical Gloves; DraftNovember 16, 1999Do.Do.
Premarket Notification (510(k)) Submissions for Testing for Skin Sensitization to Chemicals in Natural Rubber Products; FinalJanuary 13, 1999Do.Do.
CDRH Regulatory Guidance for Washers and Washer-Disinfectors Intended for Use in Processing Reusable Medical DevicesJune 2, 1998Do.Do.
Testing for Sensitizing Chemicals in Natural Rubber Latex Medical Devices (addendum to 944)July 28, 1997Do.Do.
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Addendum to Guidance on Premarket Notification (510(k)) Submissions for Sterilizers Intended for Use in Health Care FacilitiesSeptember 19, 1995Do.Do.
Guidance on the Content and Format of Premarket Notification (510(k)) Submissions for Sharps ContainersOctober 1, 1993Do.Do.
Guidance on Premarket Notification (510(k)) Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care FacilitiesAugust 1, 1993Do.Do.
Guidance on Premarket Notification (510(k)) Submissions for Surgical Gowns and Surgical DrapesAugust 1, 1993Do.Do.
Guidance on Premarket Notification 510(k) for Sterilizers Intended for Use in Health Care FacilitiesMarch 1, 1993Do.Do.
Battery GuidanceJanuary 1, 1994Do.Do.
Policy for Expiration Dating (DCRND RB92-G)October 30, 1992Do.Do.
Balloon Valvuloplasty Guidance for the Submission of an IDE Application and a PMA ApplicationJanuary 1, 1989Do.Do.
Cardiac Ablation Catheters Generic Arrhythmia Indications for Use; Guidance for IndustryJuly 1, 2002Do.Do.
Investigational Device Exemption (IDE) Study Enrollment for Cardiac Ablation of Typical Atrial Flutter; Final Guidance for Industry and FDA ReviewersNovember 8, 2000Do.Do.
Recommended Clinical Study Design for Ventricular Tachycardia AblationMay 7, 1999Do.Do.
Non-Automated Sphygmomanometer (Blood Pressure Cuff) Guidance Version 1; FinalNovember 19, 1998Do.Do.
Non-Invasive Blood Pressure (NIBP) Monitor GuidanceMarch 10, 1997Do.Do.
Electrocardiograph (ECG) ElectrodeFebruary 11, 1997Do.Do.
Electrocardiograph (ECG) Lead Switching AdapterFebruary 11, 1997Do.Do.
Electrocardiograph (ECG) Surface Electrode TesterFebruary 11, 1997Do.Do.
Draft Version Cardiac Ablation Preliminary Guidance (Data To Be Submitted to the FDA in Support Investigation Device Exemption Application)March 1, 1995Do.Do.
Draft Version Electrode Recording Catheter Preliminary Guidance (Data To Be Submitted to the FDA in Support of Premarket Notifications)March 1, 1995Do.Do.
Guidance for Annuloplasty Rings 510(k) Submissions; Final Guidance for Industry and FDA StaffJanuary 31, 2001Do.Do.
Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions; Final Guidance for Industry and FDANovember 29, 2000Do.Do.
Guidance for Extracorporeal Blood Circuit Defoamer 510(k) Submissions; Final Guidance for Industry and FDANovember 29, 2000Do.Do.
Start Printed Page 872
Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions; Final Guidance for Industry and FDA StaffNovember 13, 2000Do.Do.
Draft Replacement Heart Valve GuidanceOctober 14, 1994Do.Do.
Draft Guidance; Human Heart Valve AllograftsJune 21, 1991Do.Do.
Guidance for the Preparation of the Annual Report to the PMA Approved Heart Valve ProsthesesApril 1, 1990Do.Do.
Draft Intravascular Brachytherapy—Guidance for Data To Be Submitted to FDA in Support of Investigational Device Exemption (IDE) ApplicationsMay 24, 1996Do.Do.
Draft Guidance for the Submission of Research and Marketing Applications for Interventional Cardiology Devices: PTCA Catheters, Atherectomy Catheters, Lasers, Intravascular StentsMay 1, 1995Do.Do.
Draft Percutaneous Transluminal Coronary Angioplasty Package Insert TemplateFebruary 7, 1995Do.Do.
Coronary and Cerebrovascular Guidewire GuidanceJanuary 1, 1995Do.Do.
Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) SubmissionsNovember 1, 2000Do.Do.
Draft Guidance for Implantable Cardioverter-DefibrillatorsJune 19, 1996Do.Do.
Implantable Pacemaker Testing GuidanceJanuary 12, 1990Do.Do.
Guidance Document for Vascular Prostheses 510(k) SubmissionsNovember 1, 2000Do.Do.
Guidance for Cardiovascular Intravascular Filter 510(k) Submissions; FinalNovember 26, 1999Do.Do.
Carotid Stent—Suggestions for Content of Submissions to FDA in Support of Investigational Devices Exemption (IDE) ApplicationsOctober 26, 1996Do.Do.
Draft Guidance for the Preparation of Research and Marketing Applications for Vascular Graft ProsthesesAugust 1, 1993Do.Do.
Guidance Document for Powered Suction Pump 510(k)sSeptember 30, 1998Do.Do.
Guidance Document for Surgical Lamp 510(k)s; FinalJuly 13, 1998Do.Do.
Electroencephalograph Devices Draft Guidance for 510(k) ContentNovember 3, 1997Do.Do.
Guidelines for Reviewing Premarket Notifications That Claim Substantial Equivalence to Evoked Response StimulatorsFebruary 1, 1997Do.Do.
Guidance Document for the Preparation of Premarket Notification (510(k)) Applications for Electromyograph Needle ElectrodesJuly 26, 1995Do.Do.
Guidance on the Content and Organization of a Premarket Notification for a Medical LaserJune 1, 1995Do.Do.
Start Printed Page 873
Draft 510(k) Guideline for General Surgical Electrosurgical DevicesMay 10, 1995Do.Do.
Guidance for the Preparation of a Premarket Notification for Extended Laparoscopy DevicesAugust 30, 1994Do.Do.
Galvanic Skin Response Measurement Devices; Draft Guidance for 510(k) ContentAugust 23, 1994Do.Do.
Draft Version 1; Biofeedback Devices; Draft Guidance for 510(k) ContentAugust 1, 1994Do.Do.
Draft Version Cranial Perforator GuidanceJuly 13, 1994Do.Do.
Draft Version Neuro Endoscope GuidanceJuly 7, 1994Do.Do.
Draft Premarket Notification Review Guidance for Evoked Response Somatosensory StimulatorsJune 1, 1994Do.Do.
Draft Guidance for Arthroscope and Accessory 510(k)sMay 1, 1994Do.Do.
Class II Special Controls Guidance Document; Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDAJanuary 16, 2003Do.Do.
Class II Special Controls Guidance Document; Polymethylmethacrylate (PMMA) Bone Cement; Guidance for Industry and FDAJuly 17, 2002Do.Do.
Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented ProsthesisApril 30, 2002Do.Do.
Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semiconstrained Porous-Coated Uncemented ProsthesisOctober 31, 2000Do.Do.
Guidance for Spinal System 510(k)sSeptember 27, 2000Do.Do.
Guidance Document for the Preparation of IDEs for Spinal SystemsJanuary 13, 2000Do.Do.
Guidance Document for Industry and CDRH Staff for the Preparation of Investigational Device Exemptions and Premarket Approval Applications for Bone Growth Stimulator Devices; DraftMarch 18, 1998Do.Do.
Draft Guidance Document for the Preparation of Premarket Notification (510(k)) Applications for Orthopedic Devices—The Basic ElementsJuly 16, 1997Do.Do.
ORDB 510(k) Sterility Review GuidanceJuly 3, 1997Do.Do.
Calcium Phosphate (Ca-P) Coating Draft Guidance for Preparation of FDA Submissions for Orthopedic and Dental Endosseous ImplantsFebruary 21, 1997Do.Do.
Reviewers Guidance Checklist for Intramedullary RodsFebruary 21, 1997Do.Do.
Reviewers Guidance Checklist for Orthopedic External Fixation DevicesFebruary 21, 1997Do.Do.
510(k) Information Needed for Hydroxyapatite Coated Orthopedic ImplantsFebruary 20, 1997Do.Do.
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Guidance Document for Testing Biodegradable Polymer Implant DevicesApril 20, 1996Do.Do.
Guidance Document for Testing Bone Anchor DevicesApril 20, 1996Do.Do.
Draft Guidance Document for Femoral Stem ProsthesesAugust 1, 1995Do.Do.
Draft Guidance Document for Testing Acetabular Cup ProsthesesMay 1, 1995Do.Do.
Guidance Document for Testing Non-Articulating, “Mechanically Locked,” Modular Implant ComponentsMay 1, 1995Do.Do.
Draft Data Requirements for Ultrahigh Molecular Weight Polyethylene (Uhmupe) Used in Orthopedic DevicesMarch 28, 1995Do.Do.
Guidance Document for the Preparation of Premarket Notification for Ceramic Ball Hip SystemsJanuary 10, 1995Do.Do.
Guidance Document for Testing Orthopedic Implants With Modified Metallic Surfaces Apposing Bone or Bone CementApril 28, 1994Do.Do.
Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semiconstrained Total Knee ProsthesesApril 1, 1993Do.Do.
Guidance Document for the Preparation of IDE and PMA Applications for Intra-Articular Prothetic Knee Ligament DevicesFebruary 18, 1993Do.Do.
Class II Special Controls Guidance Document; Surgical Sutures; Guidance for Industry and FDAJune 3, 2003Do.Do.
Guidance for Saline, Silicone Gel, and Alternative Breast Implants; Guidance for Industry and FDAFebruary 11, 2003Do.Do.
Class II Special Controls Guidance Document; Human Dura Mater; Draft Guidance for Industry and FDAOctober 22, 2002Do.Do.
Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery; Guidance for IndustryJune 18, 2002Do.Do.
Guidance Document for Dura Substitute Devices; Final Guidance for IndustryNovember 9, 2000Do.Do.
Guidance for Neurological Embolization DevicesNovember 1, 2000Do.Do.
Guidance for the Preparation of a Premarket Notification Application for Processed Human Dura Mater; FinalOctober 14, 1999Do.Do.
Guidance for Dermabrasion Devices; FinalMarch 2, 1999Do.Do.
Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh; FinalMarch 2, 1999Do.Do.
Guidance for Content of Premarket Notifications for Esophageal and Tracheal Prostheses; FinalApril 28, 1998Do.Do.
Guidance for Testing MR Interaction With Aneurysm ClipsMay 22, 1996Do.Do.
Start Printed Page 875
Draft Guidance for the Preparation of IDE Submission for Interactive Wound and Burn DressingApril 4, 1995Do.Do.
Draft Guidance for the Preparation of a Premarket Notification for a Non-Interactive Wound and Burn DressingMarch 31, 1995Do.Do.
Draft Version; Guidance on Biocompatibility Requirements for Long Term Neurological Implants: Part 3—Implant ModelSeptember 12, 1994Do.Do.
Protocol for Dermal Toxicity Testing for Devices in Contact With Skin; DraftJanuary 1, 1985Do.Do.
Class II Special Controls Guidance Document; Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDAJune 2, 2003Do.Do.
Guidance Document for Powered Muscle Stimulator 510(k)s; FinalJune 9, 1999Do.Do.
Guidance Document for the Preparation of Notification (510(k)) Applications for Therapeutic Massagers and VibratorsJuly 26, 1995Do.Do.
Guidance Document for the Preparation of Premarket Notification (510(k)) Applications for BedsJuly 26, 1995Do.Do.
Guidance Document for the Preparation of Premarket Notification (510(k)) Applications for Communications Systems (Powered and Nonpowered) and Powered Environmental Control SystemsJuly 26, 1995Do.Do.
Guidance Document for the Preparation of Premarket Notification (510(k)) Applications for Exercise EquipmentJuly 26, 1995Do.Do.
Guidance Document for the Preparation of Premarket Notification (510(k)) Applications for Heating and Cooling DevicesJuly 26, 1995Do.Do.
Guidance Document for the Preparation of Premarket Notification (510(k)) Applications for Immersion HydrobathsJuly 26, 1995Do.Do.
Guidance Document for the Preparation of Premarket Notification (510(k)) Applications for Powered Tables and Multifunctional Physical Therapy TablesJuly 26, 1995Do.Do.
Guidance Document for the Preparation of Premarket Notification (510(k)) Applications for Submerged (Underwater) Exercise EquipmentJuly 26, 1995Do.Do.
Guidance Document for the Preparation of Premarket Notification (510(k)) Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled VehiclesJuly 26, 1995Do.Do.
Guide for TENS 510(k) Content; DraftAugust 1, 1994Do.Do.
Draft Version Guidance for Clinical Data To Be Submitted for Premarket Approval Application for Cranial Electrotherapy StimulatorsAugust 20, 1992Do.Do.
Draft Guidance for Cortical Electrode 510(k) ContentAugust 10, 1992Do.Do.
Guidance for Studies for Pain Therapy Devices—General Consideration in the Design of Clinical Studies for Pain-Alleviating DevicesMay 12, 1988Do.Do.
Start Printed Page 876
Accountability Analysis for Clinical Studies for Ophthalmic Devices; DraftAugust 4, 1999Do.Do.
Guidance Document for Nonprescription Sunglasses; FinalOctober 9, 1998Do.Do.
Ophthalmoscope GuidanceJuly 8, 1998Do.Do.
Retinoscope Guidance; FinalJuly 8, 1998Do.Do.
Slit Lamp Guidance; FinalJuly 8, 1998Do.Do.
Discussion Points for Expansion of the “Checklist of Information Usually Submitted in an Investigational Device Exemption (IDE) Application for Refractive Surgery Lasers;” Draft DocumentSeptember 5, 1997Do.Do.
Third Party Review Guidance for Phacofragmentation System Device Premarket Notification (510(k))January 31, 1997Do.Do.
Third Party Review Guidance for Vitreous Aspiration and Cutting Device Premarket Notification (510(k))January 31, 1997Do.Do.
Checklist of Information Usually Submitted in an Investigational Device Exemptions (IDE) Application for Refractive Surgery Lasers (excimer)October 10, 1996Do.Do.
Guidance for Manufacturers Seeking Marketing Clearance of Ear, Nose, and Throat Endoscope Sheaths Used as Protective Barriers; FinalMarch 12, 2000Do.Do.
Tympanostomy Tubes, Submission Guidance for a 510(k) Premarket Notification; FinalJanuary 14, 1998Do.Do.
Guidance for the Arrangement and Content of a Premarket Approval (PMA) Application for a Cochlear Implant in Children Ages 2 through 17 YearsMay 1, 1990Do.Do.
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, 1990Do.Do.
Refractive Implants: Guidance for Investigational Device Exemptions (IDE) and Premarket Approval (PMA) Applications; DraftAugust 1, 2000Do.Do.
Intraocular Lens Guidance Document; DraftOctober 14, 1999Do.Do.
Guidance on 510(k) Submissions for Keratoprostheses; FinalMarch 3, 1999Do.Do.
Aqueous Shunts—510(k) Submissions; FinalNovember 16, 1998Do.Do.
FDA Guidelines for Multifocal Intraocular Lens IDE Studies and PMAsMay 29, 1997Do.Do.
Important Information About Rophae Intraocular LensesAugust 20, 1992Do.Do.
Guidance for Premarket Submissions of Orthokeratology Rigid Gas Permeable Contact Lenses; FinalApril 10, 2000Do.Do.
Revised Procedures for Adding Lens Finishing Laboratories to Approved Premarket Approval Applications for Class III Rigid Gas Permeable Contact Lenses for Extended Wear; FinalAugust 11, 1998Do.Do.
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Premarket Notification 510(k) Guidance for Contact Lens Care ProductsMay 1, 1997Do.Do.
Premarket Notification (510(k)) Guidance Document for Class II Daily Wear Contact LensesJune 28, 1994Do.Do.
New FDA Recommendations and Results of Contact Lens Study (7-day letter)May 30, 1989Do.Do.
Class II Special Controls Guidance Document; Ingestible Telemetric Gastrointestinal Capsule Imaging System; Final Guidance for Industry and FDANovember 28, 2001Do.Do.
Class II Special Controls Guidance Document; Tissue Culture Media for Human Ex Vivo Tissue and Cell Culture Processing Applications; Final Guidance for Industry and FDA ReviewersMay 16, 2001Do.Do.
Guidance for Investigational Device Exemptions for Solutions for Hypothermic Flushing, Transport, and Storage of Organs for Transplantation; Final Guidance for Industry and FDA ReviewersJanuary 16, 2001Do.Do.
Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems; FinalAugust 7, 1998Do.Do.
Guidance for the Content of Premarket Notification for Conventional and High Permeability Hemodialyzers; FinalAugust 7, 1998Do.Do.
Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents; FinalFebruary 5, 1998Do.Do.
Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for HemodialysisMay 30, 1997Do.Do.
Draft Guidance for Hemodialyzer Reuse LabelingOctober 6, 1995Do.Do.
Class II Special Controls Guidance Document; Breast Lesion Documentation System; Guidance for Industry and FDA StaffJuly 28, 2003Do.Do.
Class II Special Controls Guidance for Home Uterine Activity Monitors; Final Guidance for Industry and FDA ReviewersMarch 9, 2001Do.Do.
Class II Special Controls Guidance Document for Clitoral Engorgement DevicesJuly 3, 2000Do.Do.
Draft Guidance for Industry; Electro-optical Sensors for the In Vivo Detection of Cervical Cancer and Its Precursors: Submission Guidance for an IDE/PMAAugust 25, 1999Do.Do.
Devices Used for In Vitro Fertilization and Related Assisted Reproduction Procedures; DraftSeptember 10, 1998Do.Do.
Latex Condoms for Men—Information for 510(k) Premarket Notifications: Use of Consensus Standards for Abbreviated SubmissionsJuly 23, 1998Do.Do.
Uniform Contraceptive Labeling; FinalJuly 23, 1998Do.Do.
Intrapartum Continuous Monitors for Fetal Oxygen Saturation and Fetal pH; Submission Guidance for a PMA; Draft DocumentJune 14, 1997Do.Do.
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Letter to Manufacturers of Prescription Home Monitors for Nonstress TestsSeptember 6, 1996Do.Do.
Letter to Manufacturers of FalloposcopesSeptember 5, 1996Do.Do.
Thermal Endometrial Ablation Devices (Submission Guidance for an IDE)March 14, 1996Do.Do.
Hysteroscopes and Gynecology Laparoscopes (Submission Guidance for a 510(k))March 7, 1996Do.Do.
Hysteroscopes and Laparoscopic Insufflators (Submission Guidance for a 510(k))August 1, 1995Do.Do.
Testing Guidance for Male Condoms Made From New Material (Nonlatex)June 29, 1995Do.Do.
Draft Guidance for the Content of Premarket Notifications for Menstrual TamponsMay 25, 1995Do.Do.
Information for a Latex Condom 510(k) Submission for Obstetrics-Gynecology Devices Branch; DraftApril 13, 1994Do.Do.
Premarket Testing Guidelines for FalloposcopesNovember 20, 1992Do.Do.
Draft Guidance for the Content of Premarket Notifications for Loop and Rollerball Electrodes for GYN Electrosurgical ExcisionsJuly 29, 1991Do.Do.
Premarket Testing Guidelines for Female Barrier Contraceptive Devices Also Intended to Prevent Sexually Transmitted DiseasesApril 4, 1990Do.Do.
Guidance (“Guidelines”) for Evaluation of Hysteroscopic Sterilization DevicesMay 10, 1978Do.Do.
Guidance (“Guidelines”) for Evaluation of Laparoscopic Bipolar and Thermal Coagulators (and Accessories)May 1, 1978Do.Do.
Guidance (“Guidelines”) for Evaluation of Tubal Occlusion DevicesNovember 22, 1977Do.Do.
Guidance (“Guidelines”) for Evaluation of Fetal Clip ElectrodeMarch 8, 1977Do.Do.
Guidelines for Evaluation of Nondrug IUDsSeptember 28, 1976Do.Do.
Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices; Guidance for Industry and FDA StaffJuly 14, 2003Do.Do.
Bone Sonometer PMA Applications; Final Guidance for Industry and FDAJune 21, 2001Do.Do.
Premarket Applications for Digital Mammography Systems; Final Guidance for Industry and FDAFebruary 16, 2001Do.Do.
Guidance for the Submission of Premarket Notifications for Photon-Emitting Brachytherapy SourcesAugust 2, 2000Do.Do.
Guidance for the Submission of Premarket Notifications for Medical Image Management DevicesJuly 27, 2000Do.Do.
Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices; FinalAugust 6, 1999Do.Do.
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Guidance for the Submission of Premarket Notifications for Emission Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems; FinalDecember 3, 1998Do.Do.
Guidance for the Submission of Premarket Notifications for Radionuclide Dose Calibrators; FinalNovember 20, 1998Do.Do.
Harmonic Imaging With/Without Contrast—Premarket Notification; FinalNovember 16, 1998Do.Do.
Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices; FinalNovember 14, 1998Do.Do.
Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and TransducersSeptember 30, 1997Do.Do.
Letter: Notice to Manufacturers of Bone Mineral DensitometersSeptember 25, 1997Do.Do.
Simplified 510(k) Procedures for Certain Radiology Devices: 12/21/93 letter from L. Yin, ODE/DRAERD, to NEMADecember 21, 1993Do.Do.
Draft Guidance for Review of Bone Densitometer 510(k) SubmissionsNovember 9, 1992Do.Do.
Reviewer Guidance for Automatic X-Ray Film Processor 510(k)February 1, 1990Do.Do.
Guidance for the Content of Premarket Notifications (510(k)s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral CalculiAugust 9, 2000Do.Do.
Guidance for the Content of Premarket Notifications for Penile Rigidity Implants; FinalJanuary 16, 2000Do.Do.
Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters; FinalNovember 30, 1998Do.Do.
CDRH Interim Regulatory Policy for External Penile Rigidity DevicesSeptember 10, 1997Do.Do.
Draft Guidance for Preclinical and Clinical Investigations of Urethral Bulking Agents Used in the Treatment of Urinary IncontinenceNovember 29, 1995Do.Do.
Draft Guidance for the Clinical Investigation of Urethral StentsNovember 2, 1995Do.Do.
Draft 510(k) Checklist for Endoscopic Electrosurgical Unit (ESU) and Accessories Used in Gastroenterology and UrologyAugust 16, 1995Do.Do.
Draft 510(k) Checklist for Urological Irrigation System and Tubing SetAugust 1, 1995Do.Do.
Draft 510(k) Checklist for Endoscopic Light Sources Used in Gastroenterology and UrologyJune 22, 1995Do.Do.
Draft 510(k) Checklist for Non-Implanted Electrical Stimulators Used for the Treatment of Urinary IncontinenceJune 6, 1995Do.Do.
Draft Guidance for Preparation of PMA Applications for the Implanted Mechanical/Hydraulic Urinary Continence Device (Artificial Urinary Sphincter)May 1, 1995Do.Do.
Start Printed Page 880
Draft Guidance for the Content of Premarket Notifications for Endoscopes Used in Gastroenterology and UrologyMarch 17, 1995Do.Do.
Draft 510(k) Checklist for Condom CathetersFebruary 23, 1995Do.Do.
Draft Guidance for Clinical Investigations of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH)November 11, 1994Do.Do.
Checklist for Mechanical Lithotripters and Stone Dislodgers Used in Gastroenterology and UrologyNovember 1, 1994Do.Do.
510(k) Checklist for Sterile Lubricating Jelly Used With Transurethral Surgical InstrumentsSeptember 19, 1994Do.Do.
Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley CathetersSeptember 12, 1994Do.Do.
Guidance for the Content of Premarket Notifications for Urodynamic/Uroflowmetry SystemsJuly 29, 1994Do.Do.
Guidance for the Content of Premarket Notifications for Urine Drainage BagsJune 7, 1994Do.Do.
Draft Guidance Outline—PTC for Clinical Studies for Vasovasostomy DevicesNovember 30, 1993Do.Do.
Draft Guidance for Preparation of PMA Applications for Penile Inflatable ImplantsMarch 16, 1993Do.Do.
Draft Guidance for Preparation of PMA Applications for Testicular ProsthesesMarch 16, 1993Do.Do.
Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and UrologyFebruary 10, 1993Do.Do.
Guidance for the Content of Premarket Notifications for Ureteral StentsFebruary 10, 1993Do.Do.
Draft Guidance for the Content of Premarket Notifications for Urological Balloon Dilatation CathethersJanuary 24, 1992Do.Do.
Draft of Suggested Information for Reporting Extracorporeal Shock Wave Lithotripsy Device Shock Wave MeasurementsJanuary 18, 1991Do.Do.
Draft Guidance to Firms on Biliary Lithotripsy StudiesAugust 2, 1990Do.Do.
Office of In Vitro Diagnostic Device Evaluation and Safety
Analyte Specific Reagents; Small Entity Compliance Guidance; Guidance for IndustryFebruary 26, 2003Do.Do.
Assessing the Safety/Effectiveness of Home-Use In Vitro Diagnostic Devices (IVDs): Draft PTC Regarding Labeling and Premarket SubmissionsOctober 1, 1988Do.Do.
Data for Commercialization of Original Equipment Manufacturer, Secondary and Generic Reagents for Automated AnalyzersJune 10, 1996Do.Do.
Determination of Intended Use for 510(k) Devices; Guidance for CDRH StaffDecember 3, 2002Do.Do.
Guidance for Administrative Procedures for CLIA CategorizationAugust 14, 2000Do.Do.
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Guidance for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Criteria for Waiver; Draft Guidance for Industry and FDAMarch 1, 2001Do.Do.
Guidance for Industry; Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators; FinalFebruary 22, 1999Do.Do.
Guidance on Labeling for Laboratory Tests; DraftJune 24, 1999Do.Do.
Letter to IVD Manufacturers on Streamlined PMA; FinalDecember 22, 1997Do.Do.
PTC for Collection of Data in Support of In Vitro Device Submissions for 510(k) ClearanceSeptember 26, 1994Do.Do.
PTC for Review of Calibration and Quality Control Labeling for In Vitro Diagnostic Devices (cover letter dated March 14, 1996)February 1, 1996Do.Do.
PTC Guidance Document on Assayed and Unassayed Quality Control Material; DraftFebruary 3, 1999Do.Do.
Premarket Approval Application Filing Review; Guidance for Industry and FDA StaffMay 1, 2003Do.Do.
Breath Nitric Oxide Test System; Class II Special Controls Guidance DocumentJuly 7, 2003Do.Do.
Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA ReviewersNovember 30, 2000Do.Do.
Class II Special Controls Guidance Document; Cyclosporine and Tacrolimus Assays; Guidance for Industry and FDASeptember 16, 2002Do.Do.
Draft Guidance for Prescription Use of Drugs of Abuse Assays Premarket NotificationsNovember 14, 2000Do.Do.
Draft Guidance on the Labeling for Over-the-Counter Sample Collection Systems for Drugs of Abuse TestingDecember 21, 1999Do.Do.
Guidance for 510(k)s on Cholesterol Tests for Clinical Laboratory, Physicians' Office Laboratory, and Home UseJuly 14, 1995Do.Do.
Guidance for Industry In Vitro Diagnostic Bicarbonate/Carbon Dioxide Test System; FinalJuly 6, 1998Do.Do.
Guidance for Industry In Vitro Diagnostic Chloride Test System; FinalJuly 6, 1998Do.Do.
Guidance for Industry In Vitro Diagnostic Creatinine Test System; FinalJuly 2, 1998Do.Do.
Guidance for Industry In Vitro Diagnostic Glucose Test System; FinalJuly 6, 1998Do.Do.
Guidance for Industry In Vitro Diagnostic Potassium Test System; FinalJuly 6, 1998Do.Do.
Guidance for Industry In Vitro Diagnostic Sodium Test System; FinalJuly 6, 1998Do.Do.
Guidance for Industry In Vitro Diagnostic Urea Nitrogen Test System; FinalJuly 6, 1998Do.Do.
Guidance for Industry; In Vitro Diagnostic C-Reactive Protein Immunological Test SystemJuly 20, 1998Do.Do.
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Guidance for Over-the-Counter (OTC) Human Chorionic Gonadotropin (hCG) 510(k)sJuly 22, 2000Do.Do.
Guidance for Over-the-Counter (OTC) Ovulation Predictor 510(k)sJuly 22, 2000Do.Do.
Over-the-Counter (OTC) Screening Tests for Drugs of Abuse; Guidance for Premarket NotificationsNovember 14, 2000Do.Do.
PTC for Portable Blood Glucose Monitoring Devices Intended for Bedside Use in the Neonate NurseryFebruary 20, 1996Do.Do.
Review Criteria for Assessment of In Vitro Diagnostic Devices for Drugs of Abuse Assays Using Various MethodologiesAugust 31, 1995Do.Do.
Review Criteria for Assessment of Portable Blood Glucose In Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase, or Hexokinase MethodologyFebruary 14, 1996Do.Do.
Review Criteria for Assessment of Professional Use Human Chorionic Gonadotropin (hCG) In Vitro Diagnostic Devices (IVDs)November 6, 1996Do.Do.
510(k) Submissions for Coagulation Instruments; Guidance for Industry and FDA StaffJune 19, 2003Do.Do.
Class II Special Control Guidance Document for Anti-Saccharomyces cerevisia (S. cerevisiae) Antibody (ASCA) Premarket NotificationsAugust 23, 2000Do.Do.
Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDADecember 4, 2001Do.Do.
Document for Special Controls for Erythropoietin Assay Premarket Notifications (510(k)s); FinalApril 28, 1999Do.Do.
Draft Guidance Document for 510(k) Submission of Fecal Occult Blood TestsJuly 29, 1992Do.Do.
Draft Guidance Document for 510(k) Submission of Glycohemoglobin (Glycated or Glycosylated) Hemoglobin for IVDsSeptember 30, 1991Do.Do.
Draft Guidance Document for 510(k) Submission of Immunoglobulins A, G, M, D and E Immunoglobulin System In Vitro DevicesSeptember 1, 1992Do.Do.
Draft Guidance for 510(k) Submission of Lymphocyte Immunophenotyping IVDs Using Monoclonal AntibodiesSeptember 26, 1991Do.Do.
Draft; 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 BindSeptember 10, 1992Do.Do.
Guidance Document for the Submission of Tumor Associated Antigen Premarket Notification (510(k)) to FDASeptember 19, 1996Do.Do.
Guidance for Submission of Immunohistochemistry Applications to the FDA; FinalJune 3, 1998Do.Do.
In Vitro Diagnostic Fibrin Monomer Paracoagulation Test; FinalApril 27, 1999Do.Do.
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Multiplex Tests for Heritable DNA Markers, Mutations, and Expression Patterns; Draft Guidance for Industry and FDA ReviewersFebruary 27, 2003Do.Do.
PTC for Cervical Cytology DevicesJuly 25, 1994Do.Do.
PTC for Hematology Quality Control MaterialsSeptember 30, 1997Do.Do.
Radioallergosorbent Test (RAST) Methods for Allergen-Specific Immunoglobulin E (IgE) 510(k)s; Final Guidance for Industry and FDAAugust 22, 2001Do.Do.
Review Criteria for Assessment of Alpha-Fetoprotein (AFP) In Vitro Diagnostic Devices for Fetal Open Neural Tube Defects Using Immunological Test MethodologiesJuly 15, 1994Do.Do.
Review Criteria for Assessment of Cytogenetic Analysis Using Automated and Semi-Automated Chromosome AnalyzersJuly 15, 1991Do.Do.
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, 1997Do.Do.
Review Criteria for Blood Culture SystemsAugust 12, 1991Do.Do.
Review Criteria for In Vitro Diagnostic Devices for Detection of IGM Do Antibodies to Viral AgentsAugust 1, 1992Do.Do.
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, 1994Do.Do.
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, 1996Do.Do.
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, 1992Do.Do.
Class II Special Controls Guidance Document; Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDAFebruary 5, 2003Do.Do.
Draft Review Criteria for Nucleic Acid Amplification Based In Vitro Diagnostic Devices for Direct Detection of Infectious MicroorganismsJune 14, 1993Do.Do.
Premarket Approval Applications for In Vitro Diagnostic Devices Pertaining to Hepatitis C Viruses (HCV): Assays Intended for Diagnosis, Prognosis, or Monitoring of HCV Infection, Hepatitis C, or Other HCV-Associated Disease; Draft Guidance for Industry and FDAApril 27, 2001Do.Do.
Review Criteria for Assessment of Antimicrobial Susceptibility Test DiscsOctober 30, 1996Do.Do.
Start Printed Page 884
Review Criteria for Assessment of In Vitro Diagnostic Devices for Direct Detection of Chlamydiae in Clinical SpecimensJanuary 1, 1992Do.Do.
Review Criteria for Assessment of In Vitro Diagnostic Devices for Direct Detection of Mycobacterium Spp. (Tuberculosis (TB))July 6, 1993Do.Do.
Review Criteria for Assessment of Laboratory Tests for the Detection of Antibodies to Helicobacter pyloriSeptember 17, 1992Do.Do.
Review Criteria for Devices Assisting in the Diagnosis of C. Difficile Associated DiseasesMay 31, 1990Do.Do.
Review Criteria for Devices Intended for the Detection of Hepatitis B ‘e’ Antigen and Antibody to HBeDecember 30, 1991Do.Do.
Review Criteria for Premarket Approval of In Vitro Diagnostic Devices for Detection of Antibodies to Parvovirus B19May 15, 1992Do.Do.
Office of Surveillance and Biometrics
PMA Review Statistical Checklist(no date available)Do.Do.
Statistical Aspects of Submissions to FDA: A Medical Device Perspective (also includes as appendix the article “Observed Uses and Abuses of Statistical Procedures in Medical Device Submissions”)June 1, 1984Do.Do.
Statistical Guidance for Clinical Trials of Nondiagnostic Medical DevicesJanuary 1, 1996Do.Do.
MDR Guidance Document: Remedial Action Exemption; FinalSeptember 26, 2001Industry and FDADo.
Guidance on Adverse Event Reporting for Hospitals That Reprocess Devices Intended by the Original Equipment Manufacturer for Single UseApril 24, 2001IndustryDo.
MDR Guidance Document No. 1—IOL—E1996004; FinalAugust 7, 1996Do.Do.
Common Problems: Baseline Reports and Medwatch Form 3500AJanuary 1, 1997Do.Do.
Medical Device Reporting: An Overview; FinalApril 1, 1996Do.Do.
Instructions for Completing FDA Form 3500A With Coding Manual for Form 3500A (MEDWATCH) (MDR); FinalDecember 15, 1995Do.Do.
MEDWATCH FDA Form 3500A for Use by User Facilities, Distributors and Manufacturers for Mandatory Reporting (MDR); FinalJune 1, 1993Industry and user facilitiesDo.
Variance from Manufacturer Report Number Format (MDR letter); FinalJuly 16, 1996IndustryDo.
Instructions for Completing Form 3417: Medical Device Reporting Baseline Report (MDR); FinalMarch 31, 1997Do.Do.
Medical Device Reporting—Alternative Summary Reporting (ASR) Program; Guidance for IndustryOctober 19, 2000Do.Do.
Addendum to the Instructions for Completing FDA Form 3500A With Coding Manual (MEDWATCH) (MDR); FinalJune 9, 1999Do.Do.
Start Printed Page 885
Needlesticks—Medical Device Reporting GuidanceNovember 12, 2002Industry and user facilitiesDo.
Guidance to Sponsors on the Development of a Discretionary Postmarket Surveillance Study for Permanent Implantable Cardiac Pacemaker Electrodes (Leads)June 9, 1993Industry and FDA reviewersDo.
Guidance on Criteria and Approaches for Postmarket SurveillanceNovember 2, 1998Do.Do.
Guidance on Procedures to Determine Application of Postmarket Surveillance Strategies (FDAMA); FinalFebruary 19, 1998FDA reviewersDo.
Guidance on Procedures for Review of Postmarket Surveillance Submissions (FDAMA); FinalFebruary 19, 1998Do.Do.
Guidance for Industry and FDA Staff; SMDA to FDAMA: Guidance on FDA's Transition Plan for Existing Postmarket Surveillance Protocols (FDAMA); FinalNovember 2, 1998Industry and FDA reviewersDo.
Amendment to Guidance on Discretionary Postmarket Surveillance on Pacemaker Leads; FinalMarch 30, 1994Do.Do.
Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of PostmarketFebruary 2, 2000Do.Do.
Office of Compliance
Commercial Distribution/Exhibit LetterMarch 11, 1992Do.Do.
FDA Guide for Validation of Biological Indicator Incubation TimeJanuary 1, 1986Do.Do.
Guide for Establishing and Maintaining a Calibration Constancy Intercomparison System for Microwave Oven Compliance Survey Instruments (FDA 88-8264)March 1, 1988Do.Do.
General Principles of Software Validation; Draft GuidanceJanuary 11, 2002Do.Do.
Guidance on Medical Device Tracking (FDAMA); Guidance for Industry and FDA StaffMay 23, 2003Do.Do.
Compliance Program Guidance Manual: Inspection of Medical Devices; DraftFebruary 7, 2001Do.Do.
Procedures for Laboratory Compliance Testing of Television Revivers—Part of TV PacketMay 1, 1986Do.Do.
Guidance on Quality System Regulation Information for Various Premarket Submissions; DraftFebruary 3, 2003Do.Do.
Surveillance and Detention Without Physical Examination of Surgeons' and/or Patient Examination Gloves; Guidance for IndustryJuly 26, 2000Do.Do.
Manufacturers/Assemblers of Diagnostic X-Ray Systems: Enforcement Policy for Positive-Beam Limitation (PBL) Requirements in 21 CFR 1020.31(g)October 13, 1993Do.Do.
Guidance for the Submission of Initial Reports on Diagnostic X-Ray Systems and Their Major ComponentsJanuary 1, 1982Do.Do.
Start Printed Page 886
Exemption From Reporting and Recordkeeping Requirements for Certain Sunlamp Product ManufacturersSeptember 16, 1981Do.Do.
Letter to Medical Device Industry on Endoscopy and Laparoscopy Accessories (Galdi)May 17, 1993Do.Do.
Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (FDA 89-8221)March 1, 1989Do.Do.
CPG 7133.19: Retention of Microwave Oven Test Record/Cover Letter: August 24, 1981; Retention of Records Required by 21 CFR 1002March 1, 1995Do.Do.
A Guidance 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, 1996Do.Do.
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, 1996Do.Do.
A Guide for the Submission of Abbreviated Radiation Safety Reports on Image Receptor Support Devices for Mammography X-Ray SystemsMarch 1, 1996Do.Do.
Compliance Program Guidance Manual; Field Compliance Testing of Diagnostic (Medical) X-Ray Equipment; Guidance for FDA StaffMarch 15, 2000Do.Do.
Information Disclosure by Manufacturers to Assemblers for Diagnostic X-Ray Systems; Final Guidance for Industry and FDAApril 2, 2001Do.Do.
Guide for Submission of Information on Accelerators Intended to Emit X-Radiation Required Pursuant to 21 CFR 1002.10April 1, 1971Do.Do.
Abbreviated Report on Radiation Safety for Microwave Products (Other Than Microwave Ovens)—e.g., Microwave Heating, Microwave Diathermy, RF Sealers, Induction, Dielectric Heaters, Security SystemsAugust 1, 1995Do.Do.
Guide for Preparing Reports on Radiation Safety of Microwave OvensMarch 1, 1985Do.Do.
Reporting Guide for Laser Light Shows and Displays (21 CFR 1002) (FDA 88-8140)September 1, 1995Do.Do.
Guide for Filing Annual Reports for X-Ray Components and SystemsJuly 1, 1980Do.Do.
Reporting and Compliance Guide for Television Products Including Product Report, Supplemental Report, Radiation Safety Abbreviated Report, Annual Report, Information, and GuidanceOctober 1, 1995Do.Do.
Revised Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show Products (replaces FDA 82-8127)September 1, 1995Do.Do.
Guide for Preparing Abbreviated Reports of Microwave and RF Emitting Electronic Products Intended for Medical UseSeptember 1, 1996Do.Do.
Start Printed Page 887
Letter to Manufacturers and Importers of Microwave Ovens: Information Requirements for Cookbooks and User and Service ManualsOctober 31, 1988Do.Do.
Abbreviated Report on Radiation Safety of Nonmedical Ultrasonic ProductsAugust 1, 1995Do.Do.
Guide for Preparing Product Reports for Medical Ultrasound ProductsSeptember 1, 1996Do.Do.
Letter to Manufacturers, Distributors, and Importers of Condom ProductsFebruary 23, 1994Do.Do.
Letter to Manufacturers, Importers, and Repackagers of Condoms for Contraception or Sexually-Transmitted Disease Prevention (Holt)February 13, 1989Do.Do.
Letter to Condom Manufacturers and DistributorsApril 5, 1994Do.Do.
Letter to Manufacturers/Repackers Using CottonApril 22, 1994Do.Do.
Guide for Preparing Product Reports for Lasers and Products Containing LasersSeptember 1, 1995Do.Do.
Compliance Guide for Laser Products (FDA 86-8260)September 1, 1985Do.Do.
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, 1987Do.Do.
Dental Hand Piece Sterilization (dear doctor letter)September 28, 1992Do.Do.
Latex Labeling Letter (Johnson)March 18, 1993Do.Do.
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, 1994Do.Do.
Letter to Industry, Powered Wheelchair Manufacturers, from RM JohnsonMay 10, 1993Do.Do.
Hazards of Volume Ventilators and Heated HumidifiersSeptember 15, 1993Do.Do.
Manufacturers and Initial Distributors of Sharps Containers and Destroyers Used by Health Care ProfessionalsFebruary 3, 1994Do.Do.
Ethylene Oxide; Ethylene Chlorohydrin; and Ethylene Glycol: Proposed Maximum Residue Limits and Maximum Levels of ExposureJune 23, 1978Do.Do.
Letter to Manufacturers and Users of Lasers for Refractive Surgery (excimer)October 10, 1996Do.Do.
Shielded Trocars and Needles Used for Abdominal Access During LaparoscopyAugust 23, 1996Do.Do.
Surveillance and Detention Without Physical Examination of Condoms; Draft Guidance for IndustryAugust 14, 2000Do.Do.
All U.S. Condom Manufacturers, Importers, and RepackagersApril 7, 1987Do.Do.
Manufacturers and Initial Distributors of HemodialyzersMay 23, 1996Do.Do.
Start Printed Page 888
Laser Light Show Safety—Who's Responsible? (FDA 86-8262)May 1, 1986Do.Do.
Suggested State Regulations for Control of Radiation; Volume II; Nonionizing Radiation—Lasers (FDA Pub. No. 83-8220)January 1, 1982Do.Do.
Letter to All Foreign Manufacturers and Importers of Electronic Products For Which Applicable FDA Performance Standards ExistMay 28, 1981Do.Do.
Guide for Submission of Information on Industrial X-Ray Equipment Required Pursuant to 21 CFR 1002.10March 1, 1973Do.Do.
Guide for Submission of Information on Analytical X-Ray Equipment Required Pursuant to 21 CFR 1002.10April 30, 1974Do.Do.
Guidance for the Submission of Cabinet X-Ray System Reports Pursuant to 21 CFR 1020.40February 1, 1975Do.Do.
Guide for Preparing Annual Reports in Radiation Safety Testing of Electronic Products (General)October 1, 1987Do.Do.
Computerized Devices/Processes Guidance—Application of the Medical Device GMP to Computerized Devices and Manufacturing ProcessesMay 1, 1992Do.Do.
Guide for Preparing Product Reports for Ultrasonic Therapy Products (Physical Therapy Only)August 1, 1996Do.Do.
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)November 1, 1980Do.Do.
Guide for Preparing Annual Reports for Ultrasonic Therapy ProductsSeptember 1, 1996Do.Do.
Guide for Preparing Annual Reports on Radiation Safety Testing of Sunlamps and Sunlamp Products (replaces FDA 82-8127)September 1, 1995Do.Do.
Guide for Preparing Annual Reports on Radiation Safety Testing of Mercury Vapor (replaces FDA 82-8127)September 1, 1995Do.Do.
Quality Control Guide for Sunlamp Products (FDA 88-8234)September 1, 1984Do.Do.
Guide for the Submission of Initial Reports on Computed Tomography X-Ray SystemsDecember 1, 1985Do.Do.
Guide for Preparing Product Reports on Sunlamps and Sunlamp Products (21 CFR 1002)September 1, 1995Do.Do.
Letter: Policy on Maximum Timer Interval and Exposure Schedule for Sunlamp ProductsJune 25, 1985Do.Do.
Reporting Guide for Product Reports on High Intensity Mercury Vapor Discharge Lamps (21 CFR 1002)September 1, 1995Do.Do.
Quality Control Practices for Compliance With the Federal Mercury Vapor Lamp Performance StandardMay 1, 1980Do.Do.
Keeping Up With the Microwave Revolution (FDA Publication No. 91-4160)March 1, 1990Do.Do.
Start Printed Page 889
Quality Assurance Guidelines for Hemodialysis DevicesFebruary 1, 1991Do.Do.
Letter to Manufacturers and Importers of Microwave Ovens—Open Door Operation of Microwave Ovens as a Result of Oven MiswiringMarch 28, 1980Do.Do.
Reporting of New Model Numbers to Existing Model FamiliesJune 14, 1983Do.Do.
Import: Radiation-Producing Electronic Products (FDA 89-8008)November 1, 1988Do.Do.
Unsafe Patient Lead Wires and CablesSeptember 3, 1993Do.Do.
Application of a Variance From 21 CFR 1040.11(c) for a Laser Light Show, Display, or Device (form FDA 3147)July 1, 1998Do.Do.
Letter to Trade Association: Reuse of Single-Use or Disposable Medical DevicesDecember 27, 1995Do.Do.
Design Control Guidance for Medical Device ManufacturersMarch 11, 1997Do.Do.
Keeping Medical Devices Safe from Electromagnetic InterferenceJuly 1, 1995Do.Do.
Safety of Electrically Powered Products: Letter to Medical Devices and Electronic Products Manufacturers from Lilliam Gill and BHB Correction MemoSeptember 18, 1996Do.Do.
Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals; Guidance for Industry and for FDA StaffAugust 14, 2000Do.Do.
Labeling for Electronic Anti-theft Systems; Final Guidance for IndustryAugust 15, 2000Do.Do.
Wireless Medical Telemetry Risks and Recommendations; Final Guidance for IndustrySeptember 27, 2000Do.Do.
Policy on Warning Label Required on Sunlamp ProductsJune 25, 1985Do.Do.
Policy on Lamp Compatibility (Sunlamps)September 2, 1986Do.Do.
Office of Science and Technology
Guidance on Frequently Asked Questions on Recognition of Consensus Standards (FDAMA)December 21, 1998Do.Do.
Guidance on the Recognition and Use of Consensus Standards; appendix A (FDAMA)February 19, 1998Do.Do.
CDRH Standard Operating Procedures for the Identification and Evaluation of Candidate Consensus Standard for RecognitionAugust 6, 1999Do.Do.
Guidance for Industry and FDA Reviewers: Guidance on Immunotoxicity TestingMay 6, 1999Do.Do.
WITHDRAWN GUIDANCES
Medical Devices Made With Polyvinylchloride (PVC) Using the Plasticizer di-(2-Ethylhexyl)phthalate (DEHP); Draft Guidance for Industry and FDASeptember 6, 2002N/AN/A
Start Printed Page 890
Draft Guidance on Evidence Models for the Least Burdensome Means to MarketSeptember 1, 1999Do.Do.
Modifications to Devices Subject to Premarket Approval—The PMA Supplement Decision Making Process; DraftAugust 6, 1998Do.Do.
Guidance for Industry; Contents of a Product Development Protocol; DraftJuly 27, 1998Do.Do.
New Model Medical Device Development Process; FinalJuly 21, 1998Do.Do.
Document Review by the Office of the Chief Counsel (blue book memo G96-1)June 6, 1999Do.Do.
Letter: Vascular Graft Industry (Philip Phillips)November 22, 1995Do.Do.
Color Additives for Medical Devices (Snesko)November 15, 1995Do.Do.
PMA/510(k) Triage Review Procedures (blue book memo #G94-1)May 20, 1994Do.Do.
Proposal for Establishing Mechanisms for Setting Review Priorities Using Risk Assessment and Allocating Review ResourcesJune 30, 1993Do.Do.
4-of-a-Kind PMAsOctober 1, 1999Do.Do.
Review of 510(k)s for Computer Controlled Medical Devices (blue book memo #K91-1)August 29, 1991Do.Do.
Review of Final Draft Medical Device Labeling (blue book memo #P91-4)August 29, 1991Do.Do.
Clinical Utility and Premarket Approval (blue book memo #P91-1)May 3, 1991Do.Do.
Review and Approval of PMAs of Licensees (blue book memo #P86-4)October 22, 1990Do.Do.
PMA Supplements: ODEs Letter to Manufacturers; Identifies Situation Which May Require the Submission of a PMA Supplement (blue book memo #P90-1)April 24, 1990Do.Do.
FDA Policy for the Regulation of Computer Products; DraftNovember 13, 1989Do.Do.
PMA Review Schedules (P87-1) (replaced by P94-2)March 31, 1988Do.Do.
Necessary Information for Diagnostic Ultrasound 510(k); DraftNovember 24, 1987Do.Do.
Guideline on Sterile Drug Products Produced by Aseptic ProcessingJune 1, 1987Do.Do.
ODE Regulatory Information for the Office of Compliance; Information Sharing Procedures (blue book memo #G87-2)May 15, 1987Do.Do.
Panel Review of “Me-Too” Devices (blue book memo #P86-6)July 1, 1986Do.Do.
Criteria for Panel Review of PMA Supplements (blue book memo #P86-3)January 30, 1986Do.Do.
Start Printed Page 891
PMAs-Early Review and Preparation of Summaries of Safety and Effectiveness (blue book memo #P86-1)January 27, 1986Do.Do.
Draft Guidance for the Preparation of Premarket Notification 510(k)s for Dental AlloysMarch 3, 1997Do.Do.
Premarket Guidance; Reprocessing and Reuse of Single-Use Devices; DraftJune 1, 2001Do.Do.
Guidance for Conducting Stability Testing to Support an Expiration Date Labeling Claim for Medical Gloves; DraftNovember 16, 1999Do.Do.
Draft Version Cardiac Ablation Preliminary Guidance (Data To Be Submitted to the FDA in Support Investigation Device Exemption Application)March 1, 1995Do.Do.
Draft Version Electrode Recording Catheter Preliminary Guidance (Data To Be Submitted to the FDA in Support of Premarket Notifications)March 1, 1995Do.Do.
Draft Replacement Heart Valve GuidanceOctober 14, 1994Do.Do.
Draft Guidance on Human Heart Valve AllograftsJune 21, 1991Do.Do.
Draft Intravascular Brachytherapy—Guidance for Data To Be Submitted to FDA in Support of Investigational Device Exemption (IDE) ApplicationsMay 24, 1996Do.Do.
Draft Guidance for the Submission of Research and Marketing Applications for Interventional Cardiology Devices: PTCA Catheters, Atherectomy Catheters, Lasers, Intravascular StentsMay 1, 1995Do.Do.
Draft Percutaneous Transluminal Coronary Angioplasty Package Insert TemplateFebruary 7, 1995Do.Do.
Draft Guidance for Implantable Cardioverter-DefibrillatorsJune 19, 1996Do.Do.
Draft Guidance for the Preparation of Research and Marketing Applications for Vascular Graft ProsthesesAugust 1, 1993Do.Do.
Electroencephalograph Devices Draft Guidance for 510(k) ContentNovember 3, 1997Do.Do.
Draft 510(k) Guideline for General Surgical Electrosurgical DevicesMay 10, 1995Do.Do.
Galvanic Skin Response Measurement Devices; Draft Guidance for 510(k) ContentAugust 23, 1994Do.Do.
Draft Version 1; Biofeedback Devices; Draft Guidance for 510(k) ContentAugust 1, 1994Do.Do.
Draft Version Cranial Perforator GuidanceJuly 13, 1994Do.Do.
Draft Version Neuro Endoscope GuidanceJuly 7, 1994Do.Do.
Draft Premarket Notification Review Guidance for Evoked Response Somatosensory StimulatorsJune 1, 1994Do.Do.
Draft Guidance for Arthroscope and Accessory 510(k)sMay 1, 1994Do.Do.
Start Printed Page 892
Guidance Document for Industry and CDRH Staff for the Preparation of Investigational Device Exemptions and Premarket Approval Applications for Bone Growth Stimulator Devices; DraftMarch 18, 1998Do.Do.
Draft Guidance for Preparation of Premarket Notification (510(k)) Applications for Orthopedic Devices: The Basic ElementsJuly 16, 1997Do.Do.
Calcium Phosphate (Ca-P) Coating Draft Guidance for Preparation of FDA Submission for Orthopedic and Dental Endosseous ImplantsFebruary 21, 1997Do.Do.
Draft Guidance Document for Femoral Stem ProsthesesAugust 1, 1995Do.Do.
Draft Guidance Document for Testing Acetabular Cup ProsthesesMay 1, 1995Do.Do.
Draft Data Requirements for Ultrahigh Molecular Weight Polyethylene (Uhmupe) Used in Orthopedic DevicesMarch 23, 1995Do.Do.
Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semiconstrained Total Knee ProsthesesApril 1, 1993Do.Do.
Draft Guidance for the Preparation of IDE Submission for Interactive Wound and Burn DressingApril 4, 1995Do.Do.
Draft Guidance for the Preparation of a Premarket Notification for a Non-Interactive Wound and Burn DressingMarch 31, 1995Do.Do.
Draft Version; Guidance on Biocompatibility Requirements for Long Term Neurological Implants: Part 3—Implant ModelSeptember 12, 1994Do.Do.
Protocol for Dermal Toxicity Testing for Devices in Contact with Skin; DraftJanuary 1, 1985Do.Do.
Guide for TENS 510(k) Content; DraftAugust 1, 1994Do.Do.
Draft Version Guidance for Clinical Data To Be Submitted for Premarket Approval Application for Cranial Electrotherapy StimulatorsAugust 20, 1992Do.Do.
Draft Guidance for Cortical Electrode 510(k) ContentAugust 10, 1999Do.Do.
Accountability Analysis for Clinical Studies for Ophthalmic Devices; DraftAugust 4, 1999Do.Do.
Refractive Implants: Guidance for Investigational Device Exemptions (IDE) and Premarket Approval (PMA) Applications; DraftAugust 1, 2000Do.Do.
Intraocular Lens Guidance Document; DraftOctober 14, 1999Do.Do.
Draft Guidance for Hemodialyzer Reuse LabelingOctober 6, 1995Do.Do.
Draft Guidance for Industry: Electro-Optical Sensors for the In Vivo Detection of Cervical Cancer and its Precursors; Submission Guidance for an IDE/PMAAugust 25, 1999Do.Do.
Devices Used for In Vitro Fertilization and Related Assisted Reproduction Procedures; DraftSeptember 10, 1988Do.Do.
Start Printed Page 893
Intrapartum Continuous Monitors for Fetal Oxygen Saturation and Fetal pH; Submission Guidance for a PMA; Draft DocumentJune 14, 1997Do.Do.
Draft Guidance for the Content of Premarket Notifications for Menstrual TamponsMay 25, 1995Do.Do.
Information for a Latex Condom 510(k) Submission for Obstetrics-Gynecology Devices Branch; DraftApril 13, 1994Do.Do.
Premarket Testing Guidelines for FalloscopesNovember 20, 1992Do.Do.
Draft Guidance for the Content of Premarket Notifications for Loop and Rollerball Electrodes for GYN Electrosurgical ExcisionsJuly 29, 1991Do.Do.
Draft Guidance for Review of Bone Densitometer 510(k) SubmissionsNovember 9, 1992Do.Do.
Draft Guidance for Preclinical and Clinical Investigations of Urethral Bulking Agents Used in the Treatment of Urinary IncontinenceNovember 29, 1995Do.Do.
Draft Guidance for Clinical Investigation of Urethral StentsNovember 2, 1995Do.Do.
Draft 510(k) Checklist for Endoscopic Electrosurgical Unit (ESU) and Accessories Used in Gastroenterology and UrologyAugust 16, 1995Do.Do.
Draft 510(k) Checklist for Urological Irrigation System and Tubing SetAugust 1, 1995Do.Do.
Draft 510(k) Checklist for Endoscopic Light Sources Used in Gastroenterology and UrologyJune 22, 1995Do.Do.
Draft 510(k) Checklist for Non-Implanted Electrical Stimulators Used for the Treatment of Urinary IncontinenceJune 6, 1995Do.Do.
Draft Guidance for Preparation of PMA Applications for the Implanted Mechanical/Hydraulic Urinary Continence Device (Artificial Urinary Sphincter)May 1, 1995Do.Do.
Draft Guidance for the Content of Premarket Notifications for Endoscopes Used in Gastroenterology and UrologyMarch 17, 1995Do.Do.
Draft 510(k) Checklist for Condom CathetersFebruary 23, 1995Do.Do.
Draft Guidance for Clinical Investigations of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH)November 11, 1994Do.Do.
Draft Guidance Outline; PTC for Clinical Studies for Vasovasostomy DevicesNovember 30, 1993Do.Do.
Draft Guidance for Preparation of PMA Applications for Penile Inflatable ImplantsMarch 16, 1993Do.Do.
Draft Guidance for Preparation of PMA Applications for Testicular ProsthesesMarch 16, 1993Do.Do.
Draft Guidance for the Content of Premarket Notifications for Urological Balloon Dilatation CathetersJanuary 24, 1992Do.Do.
Draft of Suggested Information for Reporting Extracorporeal Shock Wave Lithotripsy Device Shock Wave MeasurementsJanuary 18, 1991Do.Do.
Start Printed Page 894
Draft Guidance to Firms on Biliary Lithotripsy StudiesAugust 2, 1990Do.Do.
Statistical Aspects of Submissions to FDA: A Medical Device Perspective (also includes as appendix the article “Observed Uses and Abuses of Statistical Procedures in Medical Device Submissions”)June 1, 1984Do.Do.
Guidance to Sponsors on the Development of a Discretionary Postmarket Surveillance Study for Permanent Implantable Cardiac Pacemaker Electrodes (Leads)June 9, 1993Do.Do.
Amendment to Guidance on Discretionary Postmarket Surveillance on Pacemaker Leads; FinalMarch 30, 1994Do.Do.
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 Bind; DraftSeptember 10, 1992Do.Do.
Premarket Approval Applications for In Vitro diagnostic Devices Pertaining to Hepatitis C Viruses (HCV): Assays Intended for Diagnosis, Prognosis, or Monitoring of HCV Infection, Hepatitis C, Other HCV-Associated Disease; Draft Guidance for Industry and FDAApril 27, 2001Do.Do.
Premarket Approval (PMA) ManualJanuary 1998Do.Do.
SMDA Changes—PMA Manual InsertApril 17, 1992Do.Do.
Investigational Device Exemptions (IDE) Manual (FDA 96-4159)June 1, 1996Do.Do.
510(k) Manual—Premarket Notification: 510(k)—Regulatory Requirements for Medical DevicesAugust 1, 1995Do.Do.
Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for BedsJuly 26, 1995Do.Do.
1 See Internet address for Facts-on-Demand number.

Guidance Documents Issued by CFSAN

Name of DocumentDate of IssuanceIntended User or Regulatory ActivityHow to Obtain a Copy of the Document
Compliance Policy Guides ManualAugust 2000; updated in April 2001General publicationshttp://www.cfsan.fda.gov/​ guidance.html
Compliance Programs Guidance ManualMarch 1995Do.Do.
FDA Recall Policy2002Do.Do.
Guidance for FDA Staff; The Leveraging Handbook; An Agency Resource for Effective Collaborations2003Do.Do.
Guidance for Small Businesses; Submission of Comments for CFSAN Rulemaking2002Do.Do.
Investigations Operations ManualMay 1996Do.Do.
Regulatory Procedures ManualAugust 1997Do.Do.
Start Printed Page 895
Draft Guidance: Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, For Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection AgencyJuly 2003Chemical and pesticide contaminants publicationsDo.
Channels of Trade Policy for Commodities With Vinclozolin ResiduesJune 2002Do.Do.
FDA Recommendations for Sampling and Testing Yellow Corn and Dry-Milled Yellow Corn Shipments for Cry9C Protein ResiduesJanuary 2001Do.Do.
Channels of Trade Policy for Commodities With Methyl Parathion ResiduesDecember 2000Do.Do.
Action Levels for Poisonous or Deleterious Substances in Human Food and Animal Feed2000Do.Do.
Pesticides Analytical Manual1999Do.Do.
FDA Advisory for Deoxynivanol (DON) in Finished Wheat Products Intended for Human Consumption and in Grain and Grain By-Products for Animal FeedSeptember 1993Do.Do.
FDA's Cosmetic Labeling ManualOctober 1991Cosmetic publicationsDo.
Draft Guidance: Labeling for Topically Applied Cosmetic Products Containing Alpha Hydroxy Acids as IngredientsDecember 2, 2002Do.Do.
Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary SupplementsJuly 10, 2003Dietary supplements publicationsDo.
Interim Evidence-Based Ranking System for Scientific DataJuly 10, 2003Do.Do.
Structure/Function Claims: Small Entity Compliance GuideJanuary 9, 2002Do.Do.
Statement of Identity, Nutrition Labeling, and Ingredient Labeling of Dietary Supplements Small Entity Compliance GuideJanuary 1999Do.Do.
Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary SupplementsDecember 1999Do.Do.
Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific BodyJuly 1998Do.Do.
Iron-Containing Supplements and Drugs: Label Warning Statements: Small Entity Compliance GuideOctober 17, 2003Do.Do.
Providing Regulatory Submissions in Electronic Format; General ConsiderationsJuly 2001Food and color additives publicationsDo.
Providing Food and Color Additive Petitions in Electronic FormatJuly 2001Do.Do.
Electronic Submission FormsJuly 2001Do.Do.
FDA's Policy for Foods Developed by Biotechnology1995Do.Do.
Partial List of Enzyme Preparations That Are Used in Foods2001Do.Do.
Partial List of Microorganisms and Microbial-Derived Ingredients That Are Used in Food2001Do.Do.
Use of Antibiotic Resistance Marker Genes in Transgenic PlantsSeptember 1998Do.Do.
Enzyme Preparations: Chemistry Recommendations for Food Additive and GRAS Affirmation PetitionsJanuary 1993Do.Do.
Start Printed Page 896
Guidance for Submitting Requests Under 21 CFR 170.39; Threshold of Regulation for Substances Used in Food Contact Articles1996Do.Do.
PTC for the Use of Recycled Plastics in Food Packaging: Chemistry ConsiderationsDecember 1992Do.Do.
How to Submit a GRAS NoticeApril 17, 1997Do.Do.
Recommendations for Submission of Chemical and Technological Data for Direct Food Additive and GRAS Food Ingredient PetitionsMay 1993Do.Do.
Statement of Policy; Foods Derived from New Plant Varieties; NoticeMay 1992Do.Do.
Guidelines for the Preparation of Petition Submissions1996Do.Do.
Guidelines for Approval of Color Additives in Contact Lenses Intended as Colors1996Do.Do.
FDA Recommendations for Submission of Chemical and Technological Data on Color Additives for Food, Drug, or Cosmetic UseJanuary 1997Do.Do.
Estimating Exposure to Direct Food Additive and Chemical Contaminants in the DietSeptember 1995Do.Do.
Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food (also known as redbook I)1982Do.Do.
Toxicological Principles for the Safety of Food Ingredients (redbook 2000)April 2004Do.Do.
Draft Guidance; Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to CFSANSeptember 17, 2003Do.Do.
Environmental Assessment Technical HandbookMarch 1987Do.Do.
Toxicological Testing of Food Additives1983Do.Do.
Guidance on Consultation Procedures Foods Derived From New Plant VarietiesOctober 1997Do.Do.
Bovine Spongiform Encephalopathy (BSE) in Products for Human Use1997Do.Do.
Food Additive Petition Expedited Review; Guidance for Industry and CFSANJanuary 1999Do.Do.
Antimicrobial Food Additives GuidanceJuly 1999Do.Do.
Preparation of Premarket Notifications for Food Contact Substances (Food Contact Notifications (FCN)): Administrative RecommendationsMay 2002Do.Do.
Preparation of Food Contact Notifications and Food Additive Petitions for Food Contact Substances: Chemistry RecommendationsApril 2002Do.Do.
Preparation of Premarket Notifications for Food Contact Substances: Toxicology RecommendationsApril 2002Do.Do.
A Food Labeling GuideMay 1997Food labeling publicationsDo.
Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims; Small Entity Compliance GuideAugust 20, 2003Do.Do.
Start Printed Page 897
Qualified Health Claims in the Labeling of Conventional Foods and Dietary SupplementsDecember 18, 2002Do.Do.
Draft Guidance; Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using BioengineeringJanuary 2001Do.Do.
Small Business Food Labeling ExemptionJune 1996Do.Do.
Food Labeling: Questions and Answers (volume I)August 1994Do.Do.
Food Labeling: Questions and Answers (volume II)February 1996Do.Do.
Fair Packaging and Labeling Act ManualJune 1978Do.Do.
Implementation of Section 10809 of the Farm Security and Investment Act of 2002, Public Law No. 107-171, § 10809 (2002), Regarding the Petition Process to Request Approval of Labeling for Foods That Have Been Treated by Irradiation2002Do.Do.
FDA Nutrition Labeling Manual—A Guide for Developing and Using DatabasesMarch 1998Do.Do.
Guidelines for Determining Metric Equivalents of Household MeasuresOctober 1, 1993Do.Do.
Food Labeling—Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of Shell Eggs Held for Retail Distribution; Small Entity Compliance GuideJuly 2001Do.Do.
Exemptions From the Warning Label Requirement for Juice—Recommendations for Effectively Achieving a 5-Log Pathogen ReductionOctober 7, 2002Do.Do.
Food Labeling—Serving Sizes Reference Amount for Baking Powder, Baking Soda, Pectin; Small Entity Compliance GuideJuly 2001Do.Do.
Bacteriological Analytical Manual (7th ed.)1992Food processing publicatonsDo.
Bacteriological Analytical Manual Online2001Do.Do.
Questions and Answers Regarding Registration of Food Facilities (4th ed.)August 6, 2004Food and cosmetic security publicationsDo.
Cosmetics Processors and Transporters: Cosmetics Security Preventive Measures GuidanceDecember 17, 2003Do.Do.
Retail Food Stores and Food Service Establishments: Food Security Preventive Measures GuidanceDecember 17, 2003Do.Do.
What You Need to Know About Registration of Food FacilitiesNovember 25, 2003Do.Do.
What You Need to Know About Prior Notice of Imported Food ShipmentsNovember 25, 2003Do.Do.
Necessity of the Use of Food Product Categories in Registration of Food FacilitiesJuly 17, 2003Do.Do.
Dairy Farms, Bulk Milk Transporters, Bulk Milk Transfer Stations, and Fluid Milk Processors: Food Security Preventive Measures GuidanceJuly 11, 2003Do.Do.
Food Producers, Processors, and Transporters: Food Security Preventive Measures GuidanceMarch 21, 2003Do.Do.
Importers and Filers: Food Security Preventive Measures GuidanceMarch 21, 2003Do.Do.
Start Printed Page 898
Compliance Policy Guide; Guidance for FDA Staff on Registration of Food Facilities2003Do.Do.
Compliance Policy Guide; Guidance for FDA Staff on Prior Notice of Imported Foods2003Do.Do.
Prior Notice of Imported Food Questions and Answers (2nd ed.)May 2004Imports and exports publicationsDo.
Prior Notice of Imported Food: Harmonized Tariff Schedule Codes Flagged With Prior Notice IndicatorsAugust 2004Do.Do.
Guidance for Industry and FDA; Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors With Interest in Exporting to ChileMay 23, 2003Do.Do.
FDA Food Importer's Guide for Low-Acid Canned and Acidified Foods1985Do.Do.
Guidance for Industry; FDA Export Certificates2002Do.Do.
Draft Guidance; Regulatory Procedures Manual, chapter 9, subchapter: Guidance Concerning Recommending Customs' Seizure and Destruction of Imported Human and Animal Food That Has Not Been ReconditionedNovember 5, 2002Do.Do.
Guidelines Concerning Notification and Testing of Infant Formula1985Infant formula publicationsDo.
Guidelines for Evaluation of the Safety and Suitability of New Infant Formulas for Feeding Preterm Infants1988Do.Do.
Clinical Testing of Infant Formulas With Respect to Nutritional Suitability for Term Infants1988Do.Do.
Guidelines for Evaluation of the Safety and Suitability of Infant Formulas for Feeding Infants With Allergic Diseases1990Do.Do.
Guidelines for the Clinical Evaluation of New Products Used in the Dietary Management of Infants, Children, and Pregnant Women With Metabolic Disorders1987Do.Do.
The Juice HACCP Regulation: Questions and AnswersSeptember 4, 2003Juice publicationsDo.
Standardized Training Curriculum for Application of HACCP Principles to Juice ProcessingJune 2003Do.Do.
Bulk Transport of Juice Concentrates and Certain Shelf Stable JuicesApril 24, 2002Do.Do.
Juice HACCP Small Entity Compliance GuideApril 4, 2003Do.Do.
Draft Guidance; Juice HACCP Hazards and Control Guidance (1st ed.)March 3, 2004Do.Do.
Apple Juice, Apple Juice Concentrates, and Apple Juice Products—Adulteration With PatulinOctober 2001Do.Do.
The Juice HACCP Regulation: Questions and AnswersAugust 31, 2001Do.Do.
FDA Food Importer's Guide for Low-Acid Canned and Acidified Foods1985Low-acid and acidified foods publicationsDo.
Grade “A” Pasteurized Milk Ordinance (2001 revision)May 15, 2002Milk sanitation publicationsDo.
Importation of PMO Defined Dairy Products (M-I-00-4)April 11, 2000Do.Do.
Evaluation of Milk Laboratories1995Do.Do.
Start Printed Page 899
Methods of Making Sanitation Ratings of Milk Supplies1999Do.Do.
Procedures Governing the Cooperative State-Public Health Service/FDA Program for Certification of Interstate Milk Shippers1999Do.Do.
Frozen Dessert Processing Guidelines1989Do.Do.
Dry Milk Ordinance1995Do.Do.
Pasteurized Milk Ordinance1999Do.Do.
Fumonisin Levels in Human Foods and Animal FeedsNovember 9, 2001Natural toxins publicationsDo.
List of Products for Each Product CategoryOctober 8, 1992Nutrition and food science publicationsDo.
Label Declaration of Allergenic Substances in Foods; Notice to ManufacturersJune 10, 1996Do.Do.
Guidance on Labeling of Foods That Need Refrigeration by ConsumersFebruary 24, 1997Do.Do.
Interim Guidance on the Voluntary Labeling of Milk and Milk Products That Have Not Been Treated With Recombinant Bovine SomatropinFebruary 10, 1994Do.Do.
Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and VegetablesOctober 26, 1998Produce publicationsDo.
Reducing Microbial Food Safety Hazards for Sprouted SeedsOctober 1999Do.Do.
Sampling and Microbial Testing of Spent Irrigation Water During Sprout ProductionOctober 1999Do.Do.
Retail Food Stores and Food Service Establishments: Food Security Preventive Measures GuidanceDecember 17, 2003Retail food protection publicationsDo.
Foods—Adulteration Involving Hard or Sharp Foreign ObjectsFebruary 1999Sanitation publicationsDo.
Defect Action Levels (DALs)May 1998Do.Do.
Action Levels for Poisonous or Deleterious Substances in Human Food and Feed2000Do.Do.
Refusal of Inspection or Access to HACCP Records Pertaining to the Safe and Sanitary Processing of Fish and Fishery ProductsJuly 2001Seafood publicationsDo.
Seafood HACCP Transition PolicyDecember 1999Do.Do.
Seafood List1993Do.Do.
Fish and Fisheries Products Hazards and Control Guide (3rd ed.)2001Do.Do.
HACCP Regulation for Fish and Fishery Products: Questions and Answers1998Do.Do.
Implementation of Section 403(t) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(t)) Regarding the Use of the Term “Catfish”December 2002Do.Do.
Letter to Various Seafood Trade Associations Regarding the Labeling of CatfishFebruary 28, 2003Do.Do.
WITHDRAWN GUIDANCES
Start Printed Page 900
Guidance for Industry: Fumonisin Levels in Human Foods and Animal Feeds, Draft (replaced by Guidance for Industry: Fumonisin Levels in Human Foods and Animal Feeds; Final (November 2001)June 2000N/AN/A
Guidance for Industry Qualified Health Claims in the Labeling of Conventional Foods and Dietary Supplements (replaced by Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements and Interim Evidence-Based Ranking System for Scientific Data (July 2003))December 2002Do.Do.
Guidance for Industry Preparation of Premarket Notifications for Food Contact Substances: Administrative; Draft (replaced by Guidance for Industry Preparation of Premarket Notifications for Food Contact Substances: Administrative; Final (May 2002))June 2000Do.Do.
Guidance for Industry Preparation of Premarket Notifications for Food Contact Substances: Chemistry Recommendations, Draft (replaced by Guidance for Industry Preparation of Food Contact Notifications for Food Contact Substances: Chemistry Recommendations; Final (April 2002))May 2000Do.Do.
Recommendations for Chemistry Data for Indirect Food Additive Petitions (replaced by Guidance for Industry Preparation of Food Contact Notifications for Food Contact Substances: Chemistry Recommendations; Final (April 2002))June 1995Do.Do.
Guidance for Industry Preparation of Premarket Notifications for Food Contact Substances: Toxicology Recommendations (replaced by Guidance for Industry Preparation of Food Contact Notifications for Food Contact Substances: Toxicology Recommendations; Final (April 2002))September 1999Do.Do.
Iron-Containing Supplements and Drugs: Label Warning and Unit Dose Packaging Small Entity Compliance Guide (replaced by Guidance for Industry; Iron-Containing Supplements and Drugs: Label Warning Statements; Small Entity Compliance Guide (October 2003))November 1997Do.Do.
Guidance for Industry Channels of Trade Policy for Commodities With Vinclozolin Residues; Draft (replaced by Guidance for Industry Channels of Trade Policy for Commodities With Vinclozolin Residues; Final (June 2002))July 2001Do.Do.
Guidance for Industry Refusal of Inspection or Access to HACCP Records Pertaining to the Safe and Sanitary Processing of Fish and Fishery Products; Draft (replaced by Guidance for Industry Refusal of Inspection or Access to HACCP Records Pertaining to the Safe and Sanitary Processing of Fish and Fishery Products; Final (July 2001))November 2000Do.Do.
Guidance Document for Arsenic1993Do.Do.
Guidance Document for Cadmium1993Do.Do.
Guidance Document for Chromium1993Do.Do.
Guidance Document for Lead1993Do.Do.
Guidance Document for Nickel1993Do.Do.
Start Printed Page 901

Guidance Documents Issued by CVM

Name of DocumentDate of IssuanceIntended User or Regulatory ActivityHow to Obtain a Copy of the Document
#159 Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological ADI (VICH GL36)November 12, 2003FDA personnel and regulated industryInternet via http://www.fda.gov/​cvm/​guidance/​published.htm, or Communications Staff (HFV-12), FDA/CVM, 7519 Standish Pl., Rockville, MD, 301-827-3800, FAX: 301-827-4065
#158 Use of Material From Deer and Elk in Animal Feed; FinalSeptember 15, 2003Regulated industryDo.
#156 Comparability Protocols; Chemistry, Manufacturing, and Controls Information; DraftFebruary 2003Do.Do.
#153 Drugs, Biologics, and Medical Devices Derived From Bioengineered Plants for Use in Humans and Animals; DraftSeptember 2002Do.Do.
#152 Evaluating the Safety of Antimicrobial New Animal Drugs With Regard to Their Microbiological Effects on Bacteria of Human Health ConcernOctober 23, 2003Do.Do.
#151 FDA Export CertificatesJuly 2004Do.Do.
#150 Status of Clove Oil and Eugenol for Anesthesia of FishJune 11, 2002Do.Do.
#149 Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Testing (VICH GL33)May 18, 2004Do.Do.
#148 Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Developmental Toxicity Testing (VICH GL32); Final GuidanceMarch 19, 2004Do.Do.
#147 Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food; Repeat Dose (90-day) Toxicity Testing (VICH GL31)November 12, 2003Do.Do.
#145 Bioanalytical Method ValidationMay 2001Do.Do.
#144 Pre-Approval Information for Registration of New Veterinary Medicinal Products for Food-producing Animals with Respect to Antimicrobial Resistance (VICH GL27); Final GuidanceApril 27, 2004Do.Do.
#143 Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms (VICH GL30); Draft GuidanceFebruary 1, 2002Do.Do.
#142 Pharmacovigilance of Veterinary Medicinal Products: Management of Periodic Summary Update Reports (PSUs) (VICH GL29); Draft GuidanceDecember 12, 2001Do.Do.
#141 Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Carcinogenicity Testing (VICH GL28); Final GuidanceMay 24, 2004Do.Do.
#132 The Administrative New Animal Drug Application Process; DraftNovember 6, 2002Do.Do.
#126 BACPAC I: Intermediates in Drug Substance Synthesis; Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls DocumentationFebruary 2001Do.Do.
#124 Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering; DraftJanuary 2001Do.Do.
#122 Manufacture and Labeling of Raw Meat Foods for Companion and Captive Noncompanion Carnivores and OmnivoresNovember 9, 2004Do.Do.
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#121 Expedited Review for New Animal Drug Applications for Human Pathogen Reduction ClaimsMarch 6, 2001Do.Do.
# 120 Veterinary Feed Directive RegulationMarch 1, 2001Do.Do.
# 119 How CVM Intends to Handle Deficient Submissions Filed During the Investigation of a New Animal Drug; Final GuidanceAugust 29, 2002Do.Do.
#118 Mass Spectrometry for Confirmation of the Identity of Animal Drug Residues; Final GuidanceMay 1, 2003Do.Do.
#117 Pharmacovigilance of Veterinary Medical Products: Management of Adverse Event Reports (AERs) (VICH GL24); Draft GuidanceDecember 12, 2000Do.Do.
#116 Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing (VICH GL23); Final GuidanceJanuary 3, 2002Do.Do.
#115 Safety Studies for Veterinary Drug Residues in Human Food; Reproduction Toxicity Testing (VICH GL22); Final GuidanceJanuary 3, 2002Do.Do.
#114 Effectiveness of Anthelmintics: Specific Recommendations for Poultry-Gallus Gallus (VICH GL21); Final GuidanceJune 19, 2002Do.Do.
#113 Effectiveness of Anthelmintics: Specific Recommendations for Feline (VICH GL20); Final GuidanceJune 19, 2002Do.Do.
#112 Fumonisin Levels in Human Foods and Animal Feeds; Final GuidanceNovember 9, 2001Do.Do.
#111 Effectiveness of Anthelmintics: Specific Recommendations for Canine (VICH GL19); Final GuidanceJune 27, 2002Do.Do.
#110 Effectiveness of Anthelmintics: Specific Recommendations for Porcine (VICH GL16); Final GuidanceJune 27, 2002Do.Do.
#109 Effectiveness of Anthelmintics: Specific Recommendations for Equine (VICH GL15); Final GuidanceJune 27, 2002Do.Do.
#108 How to Submit Information in Electronic Format by E-mailMay 21, 2004Do.Do.
#107 How to Submit a Protocol in Electronic Format by E-mailMay 21, 2004Do.Do.
#106 The Use of Published Literature in Support of New Animal Drug ApprovalAugust 31, 2000Do.Do.
#105 Computerized Systems Used in Clinical TrialsSeptember 2004Do.Do.
#104 Content and Format of Effectiveness and Target Animal Safety Technical Sections and Final Study Reports for Submission to the Division of Therapeutic Drugs for Nonfood AnimalsJuly 10, 2001Do.Do.
#103 Possible Dioxin/PCB Contamination of Drug and Biological ProductsAugust 1999Do.Do.
#102 Manufacture and Distribution of Unapproved Piperazine Products; RevisedAugust 27, 1999Do.Do.
#100 Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients (VICH GL18); Final GuidanceMay 15, 2001Do.Do.
#99 Stability Testing of New Biotechnological/Biological Veterinary Medicinal Products (VICH GL17); Final GuidanceMarch 26, 2001Do.Do.
Start Printed Page 903
#98 Dioxin in Anticaking Agents Used in Animal Feed and Feed Ingredients; RevisedApril 14, 2000Do.Do.
#97 Effectiveness of Anthelmintics: Specific Recommendations for Caprine (VICH GL14); Final GuidanceMarch 26, 2001Do.Do.
#96 Effectiveness of Anthelmintics: Specific Recommendations for Ovine (VICH GL13); Final GuidanceMarch 26, 2001Do.Do.
#95 Efficacy of Anthelmintics: Specific Recommendations for Bovines; (VICH GL12); Final GuidanceMarch 26, 2001Do.Do.
#93 Impurities in New Veterinary Medical Products (VICH GL11)May 1, 2000Do.Do.
#92 Impurities in New Veterinary Drug Substances (VICH GL10)May 1, 2000Do.Do.
#91 Stability Testing for Medicated Premixes (VICH GL8); Final GuidanceMarch 2000Do.Do.
#90 Effectiveness of Anthelmintics: General Recommendations (VICH GL7); Final Guidance (replaces March 26, 2001)October 11, 2001Do.Do.
#89 Environmental Impact Assessments (EIAs) for Veterinary Medicinal Products (VMPs)—Phase I (VICH GL6); Final GuidanceMarch 7, 2001Do.Do.
#88 How to Submit a Request for a Meeting or Teleconference in Electronic Format by E-mailMay 21, 2004Do.Do.
#87 How to Submit a Notice of Intent to Slaughter for Human Food Purposes in Electronic Format by E-mailMay 21, 2004Do.Do.
#86 How to Submit a Notice of Final Disposition of Investigational Animals Not Intended for Immediate Slaughter in Electronic Format by E-mailMay 21, 2004Do.Do.
#85 Good Clinical Practice (VICH GL9); Final GuidanceMay 9, 2001Do.Do.
#84 Product Name Placement, Size and Prominence in Advertising and Promotional Labeling; Draft GuidanceJanuary 1999Do.Do.
#83 Chemistry, Manufacturing, and Controls Changes to an Approved NADA or ANADA; Draft GuidanceJune 1999Do.Do.
#82 Development of Supplemental Applications for Approved New Animal Drugs; Final GuidanceOctober 28, 2002Do.Do.
#80 Studies to Evaluate the Utility of Anti-Salmonella Chemical Food Additives in FeedsNovember 21, 2002Do.Do.
#79 Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by CVM; Draft GuidanceMay 16, 2003Do.Do.
#78 Consideration of the Human Health Impact of the Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in Food-Producing AnimalsDecember 13, 1999Do.Do.
#76 Questions and Answers: BSE Feed RegulationJuly 1998Do.Do.
#75 Stability Testing: Photostability Testing of New Veterinary Drug Substances and Medicinal Products; Final GuidanceSeptember 1999Do.Do.
#74 Stability Testing of New Veterinary Dosage Forms (VICH GL4); Final GuidanceSeptember 1999Do.Do.
#73 Stability Testing of New Veterinary Drug Substances and Medicinal Products (VICH GL3); Final GuidanceSeptember 1999Do.Do.
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#72 GMPs for Medicated Feed Manufacturers Not Required to Register and Be Licensed With FDAMay 1998Do.Do.
#70 Para Alimentadores de Animales Rumiantes Sin Operaciones de Mezclado de Alimentos en la GranjaFebruary 1998Do.Do.
#70 Small Entities Compliance Guide for Feeders of Ruminant Animals Without On-Farm Feed Mixing OperationsFebruary 1998Do.Do.
#69 Para Alimentadores de Animales Rumiantes Con Operaciones de Mezclado de Alimentos en la GranjaFebruary 1998Do.Do.
#69 Small Entities Compliance Guide for Feeders of Ruminant Animals With On-Farm Feed Mixing OperationsFebruary 1998Do.Do.
#68 Para Mezcladores de ProteÍnas, Fabricantes de Alimentos para Animales y DistribuidoresFebruary 1999Do.Do.
#68 Small Entities Compliance Guide for Protein Blenders, Feed Manufacturers, and DistributorsFebruary 1998Do.Do.
#67 Para Extractores de Grasa por FusionFebruary 1998Do.Do.
#67 Small Entities Compliance Guide for RenderersFebruary 1998Do.Do.
#65 Industry-Supported Scientific and Educational ActivitiesNovember 1997Do.Do.
#64 Validation of Analytical Procedures: Methodology; Final GuidanceJuly 1999Do.Do.
#63 Validation of Analytical Procedures: Definition and TerminologyJuly 1999Do.Do.
#62 Consumer-Directed Broadcast Advertisements; Final GuidanceAugust 1999Do.Do.
#61 FDA Approval of New Animal Drugs for Minor Uses and for Minor SpeciesApril 1999Do.Do.
#59 How to Submit a Notice of Claimed Investigational Exemption in Electronic Format by E-mailMay 21, 2004Do.Do.
#57 Guidance for Industry for the Preparation and Submission of Veterinary Master Files1995Do.Do.
#56 Protocol Development Guideline for Clinical Effectiveness and Target Animal Safety TrialsJuly 10, 2001Do.Do.
#55 Supportive Data for Cat Food Labels Bearing “Reduces Urinary pH” Claims: Guideline in Protocol DevelopmentJune 1994Do.Do.
#54 Draft Guideline for Utility Studies for Anti-Salmonella Chemical Food Additives in Animal Feeds (see final guidance #80)June 22, 1994Do.Do.
#53 Guideline for the Evaluation of the Utility of Food Additives in Diets Fed to Aquatic AnimalsMay 1994Do.Do.
#52 Assessment of the Effects of Antimicrobial Drug Residues From Food of Animal Origin on the Human Intestinal FloraFebruary 18, 2004Do.Do.
#50 Draft Guideline for Target Animal and Human Food Safety, Drug Efficacy, Environmental and Manufacturing Studies for Teat Antiseptic ProductsFebruary 1, 1993Do.Do.
#49 Guidance Document for Target Animal Safety and Drug Effectiveness Studies for Antimicrobial Bovine Mastitis Products (Lactating and Nonlactating Cow Products)April 4, 1996Do.Do.
Start Printed Page 905
#48 Guidance for Industry for the Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug ProductsNovember 1994Do.Do.
#45 Guideline for Uniform Labeling of Drugs for Dairy and Beef CattleAugust 1993Do.Do.
#43 Guidance on Generic Animal Drug Products Containing Fermentation-Derived Drug SubstancesOctober 1995Do.Do.
#42 Animal Drug Manufacturing Guidelines1994Do.Do.
#41 Draft Guideline for Formatting, Assembling, and Submitting New Animal Drug ApplicationsJune 1992Do.Do.
#40 Draft Guideline for the Evaluation of the Efficacy of Anticoccidial Drugs and Anticoccidial Drug Combinations in PoultryApril 1992Do.Do.
#38 Guideline for Effectiveness Evaluation of Topical/OTIC Animal DrugsAugust 21, 1984Do.Do.
#37 Guidelines for Evaluation of Effectiveness of New Animal Drugs for Use in Poultry Feeds for PigmentationMarch 1984Do.Do.
#36 Guideline for Efficacy Evaluation of Canine/Feline AnthelminticsJuly 18, 1985Do.Do.
#35 Bioequivalence GuidelineRevised October 9, 2002Do.Do.
#33 Target Animal Safety Guidelines for New Animal DrugsJune 1989Do.Do.
#31 Guidelines for the Evaluation of Bovine AnthelminticsJuly 1981Do.Do.
#29 Guidelines for the Effectiveness Evaluation of Swine AnthelminticsSeptember 30, 1980Do.Do.
#28 Animal Drug Applications Expedited Review Guideline (see Policy and Procedures Guide 1240.3135)December 3, 1997Do.Do.
#27 New Animal Drug Determination (see Policy and Procedures Guide 1240.3500)July 1989Do.Do.
#24 Guideline for Drug Combinations for Use in AnimalsOctober 1983Do.Do.
#23 Medicated Free-Choice Feeds-Manufacturing ControlsJuly 1, 1985Do.Do.
#22 Labeling of Arecoline Base Drugs Intended for Animal UseDo.Do.
#21 Nutritional Ingredients in Animal Drugs and Feeds (see Policy and Procedures Guide 1240.3420)March 1993Do.Do.
#16 Freedom of Information Summary GuidelinesMay 10, 1985Do.Do.
#13 Guidelines for Evaluation and Effectiveness of New Animal Drugs for Use in Free-Choice Feeds (revision of The Cattle Medicated Block Guideline)January 1985Do.Do.
#10 Amendment of Section II(G)(1)(b)(4) of the Preclearance GuidelinesOctober 1975Do.Do.
#9 Preclearance Guidelines for Production DrugsWithdrawn pending revisionsDo.Do.
#6 Guideline for Submitting NADAs for Generic Drugs Reviewed by NAS/NRCOctober 20, 1971; revised March 19, 1976Do.Do.
#5 Drug Stability GuidelinesDecember 1, 1990Do.Do.
Start Printed Page 906
#3 General Principles for Evaluating the Safety of Compounds Used in Food-Producing Animals (revised) (see guidance #118 for update to Section V.B.1)July 1994Do.Do.
WITHDRAWN DOCUMENTS
#58 Guidance for Industry; Good Target Animal Study Practices: Clinical Investigators and MonitorsMay 1997N/AN/A
#155 Guidance for Industry; 21 CFR Part 11; Electronic Records; Electronic Signatures, Electronic Copies of Electronic RecordsMarch 1997/February 2003Do.Do.
#154 Draft Guidance for Industry on Part 11; Electronic Records, Electronic Signatures—Scope and ApplicationMarch 1997/February 2003Do.Do.
#77 Interpretation of On-Farm Feed Manufacturing and Mixing OperationsSeptember 1998/June 2003Do.Do.
#66 Professional Flexible Labeling of Antimicrobial DrugsAugust 1998/January 2002Do.Do.
#20 Antibacterial Drugs in Animal Feeds: Antibacterial Effectiveness CriteriaDecember 2004Do.Do.
#19 Antibacterial Drugs in Animal Feeds: Animal Health Safety CriteriaDecember 2004Do.Do.
#18 Antibacterial Drugs in Animal Feeds: Human Health Safety CriteriaDecember 2004Do.Do.
#15 Guideline for Reporting the Details of Clinical Trials Using an Investigational New Animal Drug in Non-Food Producing AnimalsFebruary 1977/December 2004Do.Do.
#14 Guideline for Reporting the Details of Clinical Trials Using an Investigational New Animal Drug in Food-Producing AnimalsDecember 2004Do.Do.
#4 Guideline for Efficacy Studies for Systemic Sustained Release Sulfonamide Boluses for CattleDecember 2004Do.Do.
#2 AnthelminticsDecember 2004Do.Do.

Guidance Documents Issued by the Office of the Commissioner and the Office of Policy

Name of DocumentDate of IssuanceIntended User or Regulatory ActivityHow to Obtain a Copy of the Document
FDA Information Sheets for Institutional Review Boards and Clinical InvestigatorsSeptember 1998Regulated industryInternet via http://www.fda.gov/​oc/​ohrt/​irbs/​default.htm or Good Clinical Practice Programs (HF-34), Food and Drug Administration, 5600 Fishers Lane, rm. 9C-24, Rockville, MD 20857, 301-827-3340, http://www.fda.gov/​oc/​gcp/​guidance.html
Guidance for Industry; Computerized Systems Used in Clinical TrialsApril 1999Do.Internet via http://www.fda.gov/​ora/​compliance_​ref/​bimo/​ffinalcct.pdf or Good Clinical Practice Programs (HF-34), Food and Drug Administration, 5600 Fishers Lane, rm. 9C-24, Rockville, MD 20857, 301-827-3340, http://www.fda.gov/​oc/​gcp/​guidance.htm
Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exceptions From Informed Consent Requirements for Emergency ResearchMarch 30, 2000Do.Internet via http://www.fda.gov/​ora/​compliance_​ref/​bimo/​err_​guide.htm or Good Clinical Practice Programs (HF-34), Food and Drug Administration, 5600 Fishers Lane, rm. 9C-24, Rockville, MD 20857, 301-827-3340
Start Printed Page 907
Draft Guidance for Industry on Exports and Imports Under the FDA Export Reform and Enhancement Act of 1996February 1998Do.Internet via http://www.fda.gov/​opacom/​fedregister/​frexport.html
Guidance for FDA and Industry: Direct Final Rule ProceduresNovember 21, 1997FDA personnelInternet via http://www.fda.gov/​opacom/​morechoices/​industry/​guidance.htm, or Office of Policy, 301-827-3360
International Harmonization; Policy on StandardsOctober 11, 1995Regulated industry and FDA personnel60 FR 53078, October 11, 1995; or Office of International Programs, 301-827-4480

Guidance Documents Issued by ORA

Name of DocumentDate of IssuanceIntended User or Regulatory ActivityHow to Obtain a Copy of the Document
Mailing AddressInternet Address
Compliance Policy Guides Manual (replaces Compliance Policy Guide—January 1996)Updated December 12, 2003FDA staffNational Technical Information Service, 5285 Port Royal Rd., Springfield, VA 22161http://www.fda.gov/​ora/​cpgm
Compliance Policy Guide, Section 615.115: Extra-Label Use of Medicated Feeds for Minor SpeciesApril 2001Do.Division of Compliance Policy (HFC-230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0420http://www.fda.gov/​ora/​ compliance_ref/revisions.htm
Compliance Policy Guide, Section 608.400: Compounding of Drugs for Use in AnimalsJuly 2003Do.Do.Do.
Compliance Policy Guide, Section 555.600: Filth From Insects, Rodents, and Other Pests in FoodsNovember 14, 2002Do.Do.Do.
Compliance Policy Guide, Section 460.200: Pharmacy CompoundingMay 29, 2002Do.Do.Do.
Compliance Policy Guide, Section 575.100: Pesticide Residues in Food and Feed—Enforcement Criteria (CPG 7141.01) (revised)May 16, 2002Do.Do.Do.
Compliance Policy Guide, Section 230.150: Blood Donor Classification Statement, Paid or Volunteer DonorMay 7, 2002Do.Do.Do.
Compliance Policy Guide, Section 510.150: Apple Juice, Apple Juice Concentrates, and Apple Juice Products—Adulteration With PatulinOctober 2001Do.Do.Do.
Compliance Policy Guide, Section 555.250: Statement of Policy for Labeling and Preventing Cross-Contact of Common Food AllergensApril 2001Do.Do.Do.
Compliance Policy Guide, Section 220.100: Interstate Shipment of Biological Products for Use in Medical EmergenciesReformatted March 2001Do.Do.http://www.fda.gov/​ora/​ compliance_ref/cpg/
Start Printed Page 908
Compliance Policy Guide, Section 270.100: Final Container Labels—Allergenic Extracts Containing Glycerin; Reporting ChangesReformatted March 2001Do.Do.Do.
Compliance Policy Guide, Section 230.150: Blood Donor Incentives; DraftDecember 2000Do.Do.Do.
Compliance Policy Guide, Section 7150.09: Fraud, Untrue Statements of Material Facts, Bribery, and Illegal GratuitiesJuly 1991FDA staff and regulated industryDo.http://www.fda.gov/​ora/​ compliance_ref/cpg/cpggenl/cpg120- 100.html
Glossary of Computerized System and Software Development TerminologyAugust 1995Do.National Technical Information Service, 5285 Port Royal Rd., Springfield, VA 22161 (NTIS Order No. PB96-127352)http://www.fda.gov/​ora/​inspect_​ref/​igs/​gloss.html
Guidelines for Entry Review of Radiation-Emitting Electronic DevicesMarch 12, 1999FDA staffDivision of Import Operations and Policy (HFC-170), Office of Regional Operations, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-1218N/A
Laboratory Procedures ManualJune 1994Do.Division of Field Science (HFC-141), Food and Drug Administration, 5600 Fishers Lane, rm. 12-41, Rockville, MD 20857http://www.fda.gov/​ora/​science_​ref/​
Laboratory Procedures Manual; ch. 10: Method Validation SamplesMay 1999Do.Do.Do.
Memorandum: ORA Investigational Strategy on Gamma-Butyrolactone (GBL) and Related ProductsMay 15, 2000Do.Division of Field Investigations, Office of Regional Operations, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857N/A
IOM: Investigations Operations ManualMarch 2004Do.National Technical Information Service, 5285 Port Royal Rd., Springfield, VA 22161 (NTIS Order No. PB2001-913399)http://www.fda.gov/​ora/​inspect_​ref/​
Regulatory Procedures ManualMarch 2004Do.Do (NTIS Order No. PB97-196182)http://www.fda.gov/​ora/​ compliance_ref/rpm/default.htm
Regulatory Procedures Manual; ch. 5-7-10: Civil Money Penalty Reduction Policy for Small EntitiesMarch 2004Do.Division of Compliance Policy (HFC-230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0420Do.
Regulatory Procedures Manual; ch. 10-9: Application Integrity PolicyMarch 2004Do.Do.Do.
Start Printed Page 909
Regulatory Procedures Manual; ch. 9: Import Operations/ActionsSeptember 2002Do.Do.Do.
Regulatory Procedures Manual; ch. 6-1: SeizureMarch 2004Do.Do.Do.
Regulatory Procedures Manual; ch. 6-6: Civil Penalties—Electronic Product Radiation ControlMarch 2004Do.Do.Do.
Regulatory Procedures Manual; ch. 4-1: Warning LettersMarch 2004Do.Do.http://www.fda.gov/​ora/​ compliance_ref/rpm_new2/ch4.html
Guide to Inspections of Bulk Pharmaceutical ChemicalsMay 1994Do.National Technical Information Service, 5285 Port Royal Rd., Springfield, VA 22161 (NTIS Order No. PB96-127154)http://www.fda.gov/​ora/​inspect_​ref/​igs/​iglist.html
Guide to Inspections of Pharmaceutical Quality Control LaboratoriesJuly 1993Do.Do (NTIS Order No. PB96-127279)Do.
Guide to Inspections of Microbiological Pharmaceutical Quality Control LaboratoriesJuly 1993Do.Do (NTIS Order No. PB96-127287)Do.
Guide to Inspections of Validation of Cleaning ProcessesJuly 1993Do.Do (NTIS Order No. PB96-127246)Do.
Guide to Inspections of Lyophilization of ParenteralsJuly 1993Do.Do (NTIS Order No. PB96-127253)Do.
Guide to Inspections of High Purity Water SystemsJuly 1993Do.Do (NTIS Order No. PB96-127261)Do.
Guide to Inspections of Dosage Form Drug Manufacturers—CGMPsOctober 1993Do.Do (NTIS Order No. PB96-127212)Do.
Guide to Inspections of Oral Solid Dosage Forms Pre/Post Approval Issues for Development and ValidationJanuary 1994Do.Do (NTIS Order No. PB96-127345)Do.
Guide to Inspections of Topical Drug ProductsJuly 1994Do.Do (NTIS Order No. PB96-127394)Do.
Guide to Inspections of Sterile Drug Substance ManufacturersJuly 1994Do.Do (NTIS Order No. PB96-127295)Do.
Guide to Inspections of Oral Solutions and SuspensionsAugust 1994Do.Do (NTIS Order No. PB96-127147)Do.
Guide to Nutritional Labeling and Education Act (NLEA) RequirementsFebruary 1995Do.Do (NTIS Order No. PB96-127378)Do.
Guide to Inspections of Interstate Carriers and Support FacilitiesApril 1995Do.Do (NTIS Order No. PB96-127386)Do.
Guide to Inspections of Dairy Product ManufacturersApril 1995Do.Do (NTIS Order No. PB96-127329)Do.
Guide to Inspections of Manufacturers of Miscellaneous Foods—vol. 1May 1995Do.Do (NTIS Order No. PB97-127220)Do.
Guide to Inspections of Manufacturers of Miscellaneous Food Products—vol. 2September 1996Do.Do (NTIS Order No. PB97-196133)Do.
Start Printed Page 910
Guide to Inspections of Cosmetic Product ManufacturersFebruary 1995Do.Do (NTIS Order No. PB96-127238)Do.
Guide to Inspections of Low Acid Canned Food Manufacturers, Part 1—Administrative Procedures/Scheduled ProcessesNovember 1996Do.Do (NTIS Order No. PB97-196141)Do.
Guide to Inspections of Low Acid Canned Food Manufacturers, Part 2—Manufacturing Processes/ProceduresApril 1997Do.Do (NTIS Order No. PB97-196158)Do.
Guide to Inspections of Low Acid Canned Food Manufacturers, Part 3—Container/ClosuresNovember 1998FDA staffDo (NTIS Order No. PB00-133795)N/A
Guide to Inspections of Blood BanksSeptember 1994Do.Do (NTIS Order No. PB96-127303)http://www.fda.gov/​ora/​inspect_​ref/​igs/​iglist.html
Guide to Inspections of Source Plasma EstablishmentsRevised April 2001Do.N/ADo.
Guide to Inspections of Infectious Disease Marker Testing FacilitiesOctober 1996Do.National Technical Information Service, 5285 Port Royal Rd., Springfield, VA 22161 (NTIS Order No. PB96-199476)Do.
Biotechnology Inspection Guide Reference Materials and Training AidsNovember 1991Do.Do (NTIS Order No. PB96-127402)Do.
Guide to Inspection of Computerized Systems in Drug ProcessingFebruary 1983Do.Do (NTIS Order No. PB96-127337)Do.
Guide to Inspections of Foreign Medical Device ManufacturersSeptember 1995Do.Do (NTIS Order No. PB96-127311)Do.
Guide to Inspections of Foreign Pharmaceutical ManufacturersMay 1996Do.Do (NTIS Order No. PB96-199468)Do.
Guide to Inspections of Medical Device ManufacturersDecember 1997Do.Do (NTIS Order No. PB 98-127145 )Do.
Mammography Quality Standards Act (MQSA) Auditor's GuideJanuary 1998Do.Do (NTIS Order No. PB98-127178)Do.
Guide to Inspections of Electromagnetic Compatibility Aspects of Medical Device Quality SystemsDecember 1997Do.Do (NTIS Order No. PB98-127152)Do.
Guide to Inspections of Acidified Food ManufacturersMay 1998Do.N/ADo.
Guide to Inspection of Aseptic Processing and Packaging for the Food IndustryFebruary 2001Do.Division of Field Investigations, Office of Regional Operations, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857N/A
Guide to Inspections of Grain Product ManufacturersJuly 2003Do.Do (NTIS Order No. PB98-137128)Do.
Guide to Bioresearch Monitoring Inspections of In Vitro Diagnostic DevicesFebruary 1998Do.Do (NTIS Order No. PB98-137151)Do.
Guide to Inspections of Viral Clearance Processes for Plasma DerivativesMarch 1998Do.Do (NTIS Order No. PB-98137144)Do.
Start Printed Page 911
Guide to Traceback of Fresh Fruits and Vegetables Implicated in Epidemiological InvestigationsApril 2001Do.N/ADo.
Guide to Inspections of Computerized Systems in the Food Processing IndustryAugust 1998Do.National Technical Information Service, 5285 Port Royal Rd., Springfield, VA 22161 (NTIS Order No. PB98-137136)Do.
Guide to International Inspections and Travel (revision) (formerly FDA/ORA International Inspection Manual and Travel Guide)November 2002Do.N/Ahttp://www.fda.gov/​ora/​inspect_​ref/​giit/​ default.htm
Guide to Inspections of Quality SystemsAugust 1999Do.N/Ahttp://www.fda.gov/​ora/​inspect_​ref/​igs/​qsit/​QSITGUIDE.PDF
Guide to Inspection of Firms Producing Food Products Susceptible to Contamination With Allergenic IngredientsAugust 2001Do.N/Ahttp://www.fda.gov/​ora/​inspect_​ref/​igs/​iglist.html
Computerized Systems Used in Clinical TrialsApril 1999Do.N/Ahttp://www.fda.gov/​ora/​ compliance_ref/bimo/
Compliance Program 7348.001: Bioresearch Monitoring, Human Drugs, In Vivo BioequivalenceOctober 1, 1999Do.Division of Compliance Policy (HFC-230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0420Do.
Guide for Detecting Fraud in Bioresearch Monitoring InspectionsApril 2003Do.Division of Freedom of Information (HFI-35), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857N/A
Good Laboratory Practice Program 7348.808A (Nonclinical Laboratories); EPA Data Audit InspectionsOctober 1, 2000Do.Division of Compliance Policy (HFC-230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0420http://www.fda.gov/​ora/​ compliance_ref/bimo/
Guideline for the Monitoring of Clinical InvestigationsJanuary 1988FDA regulated industryDo.Do.
Small Business Guide to FDARevised March 31, 2004Do.Federal-State Relations (HFC-150), Office of Regulatory Affairs, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-2905http://www.fda.gov/​ora/​fed_​state/​small_​business/​sb_​guide/​default.htm
Compliance Program 7348.808; Bioresearch Monitoring, Good Laboratory Practice (Nonclinical Laboratories)Revised February 21, 2001FDA staffDivision of Compliance Policy (HFC-230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0420http://www.fda.gov/​ora/​ compliance_ref/bimo/
Start Printed Page 912
Compliance Program 7348.809; Bioresearch Monitoring; Institutional Review BoardOctober 1, 1994Do.Do.Do.
Compliance Program 7348.811; Bioresearch Monitoring, Clinical InvestigatorsOctober 1, 1997Do.Do.Do.
Good Laboratory Practice Regulations; Management Briefings; Post Conference ReportAugust 1979Do.Do.Do.
Good Laboratory Practices; Questions and AnswersJune 1981Do.Do.Do.
Guidance for FDA Staff on Sampling or Detention Without Physical Examination of Decorative Contact Lenses (Import Alert #86-10)April 4, 2003FDA staffN/Ahttp://www.fda.gov/​ohrms/​dockets/​98fr/​03-8315.pdf
Compliance Policy Guide; Section 345.100: Male Condom Defects (CPG 7124.21); DraftMarch 29, 2002FDA staff and industryDivision of Compliance Policy (HFC-230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0420http://www.fda.gov/​ora/​ compliance_ref/cpg/
PTC for Internal Reviews and Corrective Action Operating PlansJune 1991Do.N/Ahttp://www.fda.gov/​ora/​ compliance_ref/aip_points.html
WITHDRAWALS
Compliance Policy Guide—Section 305.100: Acupuncture Devices and Accessories (CPG 7124.11)June 15, 1976FDA staff and industryN/A
Compliance Policy Guide—Section 396.100: Applicability of the Sunlamp Performance Standard to UVA Tanning Products (CPG 7133.16)October 1, 1980Do.Do.
Compliance Policy Guide—Section 391.100: Advertisement Literature for High-Intensity Mercury Vapor Discharge Lamps (CPG 7133.13)October 1, 1980Do.Do.
Compliance Policy Guide—Section 315.200: Status of Dental Supplies Such As Denture Cleaners, Adhesives, Cushions, and Repair Materials as a Device or Cosmetic (CPG 7124.05)April 26, 1976Do.Do.
Compliance Policy Guide—Section 398.475: Minimum X-Ray Field Size for Spot-Film Operation of Fluoroscopic Systems With Fixed SID and Without Stepless Adjustment of the Field Size (CPG 7133.17)October 1, 1980Do.Do.
Medical Device Warning Letter Pilot TerminationMarch 8, 1999Do.Do.
Compliance Policy Guide—Section 160.850: Enforcement Policy: 21 CFR Part 11; Electronic Records; Electronic Signatures (CPG 7153.17)May 13, 1999Do.Do.
Draft Guidance—21 CFR Part 11; Electronic Records; Electronic Signatures, Electronic Copies of Electronic RecordsAugust 2002Do.Do.
Start Printed Page 913
Draft Guidance—21 CFR Part 11; Electronic Records; Electronic Signatures ValidationAugust 2001Do.Do.
Draft Guidance—21 CFR Part 11; Electronic Records; Electronic Signatures, Glossary of TermsAugust 2001Do.Do.
Draft Guidance—21 CFR Part 11; Electronic Records; Electronic Signatures, Time StampsFebruary 2002Do.Do.
Draft Guidance—21 CFR Part 11; Electronic Records; Electronic Signatures, Maintenance of Electronic RecordsJuly 2002Do.Do.
Compliance Policy Guide—Section 300.700: Direct Reference Authority for Class III Medical Devices Without a Premarket Notification (510(k)) or an Approved Premarket Approval Application (PMA) (CPG 7124.30)February 26, 1991Do.Do.
Compliance Policy Guide—Section 405.100: Prescriptions Prepared From Certified Antibiotics (CPG 7122.01)October 1, 1980Do.Do.
Compliance Policy Guide—Section 405.200: Export of Uncertified Antibiotics (CPG 7122.02)October 1, 1980Do.Do.
Compliance Policy Guide—Section 405.210: Returned Antibiotics Exported Under 801(d) of the Act (CPG 7122.03)July 1, 1981Do.Do.
Draft Compliance Policy Guide—Distributor Medical Device ReportingAugust 28, 1997Do.Do.
Start Signature

Dated: December 22, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. 05-155 Filed 1-4-05; 8:45 am]

BILLING CODE 4160-01-S