[Federal Register Volume 63, Number 38 (Thursday, February 26, 1998)]
[Notices]
[Pages 9795-9843]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-4916]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N-0046]
Comprehensive List of Current Guidance Documents at the Food and
Drug Administration
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is publishing a
comprehensive list of all guidance documents currently in use at the
agency. FDA committed to publishing this list in its February 1997
``Good Guidance Practices'' (GGP's), which set forth the agency's
policies and procedures for the development, issuance, and use of
guidance documents. This list is intended to inform the public of the
existence and availability of all current guidance documents, including
those documents that were issued prior to the adoption of the GGP's.
DATES: General comments on this list and on agency guidance documents
are welcome at any time.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFD-305), Food and Drug Administration, 12420 Parklawn Dr., rm 1-23,
Rockville, MD 20857. Information on where to obtain single copies of a
listed guidance document is provided for each agency center
individually in the specific center's list of guidance documents.
FOR FURTHER INFORMATION CONTACT: Lisa L. Barclay, Office of Policy (HF-
22), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-827-3360.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of February 27, 1997 (62 FR 8961), FDA
published a notice announcing its ``Good Guidance Practices'' (GGP's),
which set forth the agency's policies and procedures for the
development, issuance, and use of guidance documents. The agency
adopted the GGP's to ensure public involvement in the development of
guidance documents and to enhance public understanding of the
availability, nature, and legal effect of such guidance.
As part of FDA's effort to ensure meaningful interaction with the
public regarding guidance documents, the agency committed to publish a
comprehensive list of all guidance documents that are currently in
effect. This comprehensive list is maintained on the FDA World Wide Web
home page. The list will be updated and published annually in the
Federal Register. FDA also has committed to publish quarterly a Federal
Register notice that lists all guidance documents that were issued and
withdrawn during that quarter. FDA also has undertaken to publish, on a
quarterly basis, a list of all new ``Level 2'' guidance documents
issued by the agency under the GGP's. In a separate notice in a future
issue of the Federal Register, FDA will publish its first quarterly
update including a list of Level 2 guidance documents issued during
that quarter.
The following list of guidance documents represents all guidances
issued by FDA that are currently in effect. The documents are organized
by the issuing Center or Office within FDA, and are further grouped by
the intended users or regulatory activities to which they pertain.
Dates provided in the following list refer to the date of issuance or,
where applicable, the date of last revision of the document. Document
numbers are provided where available, and guidance documents that are
still in draft form and on which public comment has been requested are
so identified.
This cumulative list includes guidance documents that were issued
prior to the adoption of the GGP's. At the time such documents are
substantively revised, FDA will update them to include the standard
guidance elements and nomenclature described in the GGP's.
II. Guidance Documents Issued by the Center for Biologics
Evaluation and Research (CBER)
[[Page 9796]]
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How to Obtain a Hard Copy of
Grouped by Intended the Document (Name and
Name of Document Date of Issuance User or Regulatory Address, Phone, FAX, E-mail,
Activity or Internet)
----------------------------------------------------------------------------------------------------------------
Requirements for Infrequent August 27, 1982 FDA Regulated Office of Communication,
Plasmapheresis Donors Industries Training and Manufacturers
Assistance, 1401 Rockville
Pike, Rockville, MD 20852-
1448, 301-827-1800 or 1-800-
835-4709, FAX Information
System: 1-888-CBER-FAX
(within U.S.) 301-827-3844
(outside U.S. and local to
Rockville, MD) Internet
access: http://www.fda.gov/
cber/ Recommendations to Decrease the Risk March 24, 1983 Do Do
of Transmitting AIDS from Plasma
Donors
Deferral of Blood Donors Who Have February 28, 1984 Do Do
Received the Drug Accutane
(isotretinoin/Roche); 13-cis-retinoic
acid)
Equivalent Methods for Compatibility December 14, 1984 Do Do
Testing
Plasma Derived from Therapeutic Plasma December 14, 1984 Do Do
Exchange
Reduction of the Maximum Platelet June 2, 1986 Do Do
Storage Period to 5 Days in an
Approved Container
Deferral of Donors Who Have Received November 25, 1987 Do Do
Human Pituitary-Derived Growth
Hormone
Recommendations for the Management of December 2, 1987 Do Do
Donors and Units That Are Initially
Reactive for Hepatitis B Surface
Antigen (HBsAg)
Extension of Dating Period for Storage December 4, 1987 Do Do
of Red Blood Cells, Frozen
To Licensed In-Vitro Diagnostic December 23, 1987 Do Do
Manufacturers: Handling of Human
Blood Source Materials
Recommendations for Implementation of April 6, 1988 Do Do
Computerization in Blood
Establishments
Control of Unsuitable Blood and Blood April 6, 1988 Do Do
Components
Discontinuance of Prelicensing July 7, 1988 Do Do
Inspection for Immunization Using
Licensed Tetanus Toxoid and Hepatitis
B and Rabies Vaccines
Physician Substitutes August 15, 1988 Do Do
To Licensed Manufacturers of Blood August 26, 1988 Do Do
Grouping Reagents: Criteria for
Exemption of Lot Release
To Manufacturers of HTLV-I Antibody October 18, 1988 Do Do
Test Kits: Antibody to Human T-Cell
Lymphotropic Virus, Type I (HTLV-I)
Release Panel I
HTLV-1 Antibody Testing November 29, 1988 Do Do
Use of Recombigen HIV-1 LA Test February 1, 1989 Do Do
Guidance for Autologous Blood and March 15, 1989 Do Do
Blood Components
HTLV-I Antibody Testing July 6, 1989 Do Do
Use of Recombigen HIV-1 Latex August 1, 1989 Do Do
Agglutination (LA) Test
Requirements for Computerization of September 8, 1989 Do Do
Blood Establishments
Abbott Laboratories' HIVAG-1 Test for October 4, 1989 Do Do
HIV-1 Antigen(s) Not Recommended for
Use as a Donor Screen
Autologous Blood Collection and February 12, 1990 Do Do
Processing Procedures
Use of Genetic Systems HIV-2 EIA June 21, 1990 Do Do
Deficiencies Relating to the March 20, 1991 Do Do
Manufacture of Blood and Blood
Components
Responsibilities of Blood March 20, 1991 Do Do
Establishments Related to Errors &
Accidents in the Manufacture of Blood
and Blood Components
Revision to October 26, 1989 Guideline April 17, 1991 Do Do
for Collection of Blood or Blood
Products from Donors with Positive
Tests for Infectious Disease Markers
(High Risk Donors)
FDA Recommendations Concerning Testing September 10, 1991 Do Do
for Antibody to Hepatitis B Core
Antigen (Anti-HBc)
Disposition of Blood Products Intended September 11, 1991 Do Do
for Autologous Use That Test
Repeatedly Reactive for Anti-HCV
[[Page 9797]]
Clarification of FDA Recommendations December 12, 1991 Do Do
for Donor Deferral and Product
Distribution Based on the Results of
Syphilis Testing
Revised Recommendations for the April 23, 1992 Do Do
Prevention of Human Immunodeficiency
Virus (HIV) Transmission by Blood and
Blood Products
Use of Fluorognost HIV-1 April 23, 1992 Do Do
Immunofluorescent Assay (IFA)
Revised Recommendations for Testing April 23, 1992 Do Do
Whole Blood, Blood Components, Source
Plasma and Source Leukocytes for
Antibody to Hepatitis C Virus Encoded
Antigen (Anti-HCV)
Exemptions to Permit Persons with a April 23, 1992 Do Do
History of Viral Hepatitis Before the
Age of Eleven Years to Serve as
Donors of Whole Blood and Plasma;
Alternative Procedures (21 CFR
640.120)
Changes in Equipment for Processing July 21, 1992 Do Do
Blood Donor Samples
Nomenclature for Monoclonal Blood September 28, 1992 Do Do
Grouping Reagents
Volume Limits for Automated Collection November 4, 1992 Do Do
of Source Plasma
Revision of October 7, 1988 Memo December 16, 1992 Do Do
Concerning Red Blood Cell
Immunization Programs
Recommendations Regarding License July 22, 1993 Do Do
Amendments and Procedures for Gamma
Irradiation of Blood Products
Deferral of Blood and Plasma Donors July 28, 1993 Do Do
Based on Medications
Revised Recommendations for Testing August 19, 1993 Do Do
Whole Blood, Blood Components, Source
Plasma and Source Leukocytes for
Antibody to Hepatitis C Virus Encoded
Antigen (Anti-HCV)
Changes in Administrative Procedures September 9, 1993 Do Do
Guidance Regarding Post Donation December 10, 1993 Do Do
Information Reports
Donor Suitability Related to December 22, 1993 Do Do
Laboratory Testing for Viral
Hepatitis and a History of Viral
Hepatitis
Recommendations for the Invalidation January 3, 1994 Do Do
of Test Results When Using Licensed
Viral Marker Assays to Screen Donors
Recommendations for Deferral of Donors July 26, 1994 Do Do
for Malaria Risk
Use of and FDA Cleared or Approved August 5, 1994 Do Do
Sterile Docking Device (STCD) in
Blood Bank Practices (transmittal
memo 8/12/94) (corrects 7/29/94 Memo)
Recommendations to Users of Medical December 20, 1994 Do Do
Devices That Test for Infectious
Disease Markers by Enzyme Immunoassay
(EIA) Test Systems
Timeframe for Licensing Irradiated February 3, 1995 Do Do
Blood Products
Revision of 8/27/82 FDA Memo: March 10, 1995 Do Do
Requirements for Infrequent
Plasmapheresis Donors
To All Establishments Performing Red March 14, 1995 Do Do
Blood Cell Immunizations: Revised
Recommendations for Red Blood Cell
Immunization Programs for Source
Plasma
Recommendations for the Deferral of June 8, 1995 Do Do
Current and Recent Inmates of
Correctional Institutions as Donors
of Whole Blood, Blood Components,
Source Leukocytes and Source Plasma
Disposition of Products Derived from August 8, 1995 Do Do
Donors Diagnosed with, or at Known
High Risk for, Creutzfeldt-Jakob
Disease
Recommendations for Labeling and Use August 8, 1995 Do Do
of Units of Whole Blood, Blood
Components, Source Plasma, Recovered
Plasma or Source Leukocytes Obtained
from Donors with Elevated Levels of
Alanine Aminotransferase (ALT)
[[Page 9798]]
Precautionary Measures to Further August 8, 1995 Do Do
Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob
Disease by Blood and Blood Products
Recommendations for Donor Screening August 8, 1995 Do Do
with a Licensed Test for HIV-1
Antigen
Guidance Concerning Conversion to FDA- November 13, 1995 Do Do
Reviewed Software Products
Donor Deferral Due to Red Blood Cell December 4, 1995 Do Do
Loss During Collection of Source
Plasma by Automated Plasmapheresis
Additional Recommendations for Donor March 14, 1996 Do Do
Screening With a Licensed Test for
HIV-1 Antigen
Additional Recommendations for Testing May 16, 1996 Do Do
Whole Blood, Blood Components,
SourcePlasma and Source Leucocytes
for Antibody to Hepatitis C Virus
Encoded Antigen (Anti-HCV)
Recommendations and Licensure May 29, 1996 Do Do
Requirements for Leukocyte-Reduced
Blood Products
Recommendations for the Quarantine and July 19, 1996 Do Do
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)
Interim Recommendations for Deferral December 11, 1996 Do Do
of Donors at Increased Risk for HIV-1
Group O Infection
Revised Precautionary Measures to December 11, 1996 Do Do
Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob
Disease (CJD) by Blood and Blood
Products
Interstate Shipment of Interferon for November 21, 1983 Do Do
Investigational Use in Laboratory
Research Animals or Tests in Vitro
Alternatives to Lot Release July 20, 1993 Do Do
Application of Current Statutory October 14, 1993 Do Do
Authorities to Human Somatic Cell
Therapy Products and Gene Therapy
Products; Notice
Home Specimen Collection Kit Systems February 23, 1995 Do Do
Intended for Human Immunodeficiency
Virus (HIV-1 and/or HIV-2) Antibody
Testing; Revisions to Previous
Guidance
Interim Definition and Elimination of December 8, 1995 Do Do
Lot-by-Lot Release for Well-
Characterized Therapeutic Recombinant
DNA-Derived and Monoclonal Antibody
Biotechnology Products
Guidance for Industry in Designing June 24, 1996 Do Do
Clinical Programs for Developing
Human Drugs, Medical Devices, or
Biological Products Intended for the
Treatment of Rheumatoid Arthritis;
Availability of Draft Guidance;
Notice of Public Workshop on Juvenile
Rheumatoid Arthritis
Draft Public Health Service Guideline September 23, 1996 Do Do
on Infectious Disease Issues in
Xenotransplantation; Notice
The Food and Drug Administration's February 27, 1997 Do Do
Development, Issuance, and Use of
Guidance Documents
Preclearance of Promotional Labeling; March 5, 1997 Do Do
Clarification
Draft Guidance for Industry: June 18, 1997 Do Do
Computerized Systems Used in Clinical
Trials; Availability
Recommended Methods for Short Ragweed November 1, 1985 Do Do
Pollen Extracts
Information Relevant to the August 23, 1989 Do Do
Manufacture of Acellular Pertussis
Vaccine
Recommended Methods for Blood Grouping March 1, 1992 Do Do
Reagents Evaluation
Recommended Methods for Evaluating March 1, 1992 Do Do
Potency, Specificity and Reactivity
of Anti-Human Globulin
Methods of the Allergenic Products October 1, 1993 Do Do
Testing Laboratory
[[Page 9799]]
Guide to Inspections of Blood Banks, September 1, 1994 Do Do
Division of Field Investigations,
Office of Regional Operations, Office
of Regulatory Affairs
Guide to Inspections of Infectious June 1, 1996 Do Do
Disease Marker Testing Facilities
Guide to Inspections of Source Plasma June 1, 1997 Do Do
Establishments (Division of Field
Investigations, Office of Regional
Operations, Office of Regulatory
Affairs)
Notification Process for Transfusion October 7, 1997 Do Do
Related Fatalities and Donation
Related Deaths (revised telephone
number)
Submission Requirements for Requesting October 15, 1997 Do Do
Certificates for Exporting Products
to Foreign Countries
CBER Refusal to File (RTF) Guidance July 12, 1993 Do Do
for Product and Establishment License
Applications
OELPS, Advertising and Promotional August 1, 1994 Do Do
Labeling Staff Procedural Guidance
Document (Draft)
Guidance on Alternatives to Lot October 27, 1994 Do Do
Release for Licensed Biological
Products
Content and Format of Investigational November 1, 1995 Do Do
New Drug Applications (INDs) for
Phase 1 Studies of Drugs, Including
Well-Characterized, Therapeutic,
Biotechnology-derived Products
Computer Assisted Product License March 1, 1996 Do Do
Application (CAPLA) Guidance Manual
FDA Guidance Concerning Demonstration April 26, 1996 Do Do
of Comparability of Human Biological
Products, Including Therapeutic
Biotechnology-Derived Products
Guidance for Industry--The Content and May 23, 1996 Do Do
Format for Pediatric Use Supplements
Guidance on Applications for Products May 24, 1996 Do Do
Comprised of Living Autologous Cells
Manipulated Ex Vivo and Intended for
Structural Repair of Reconstruction
Guidance for Industry for the August 15, 1996 Do Do
Submission of Chemistry,
Manufacturing, and Controls
Information for a Therapeutic
Recombinant DNA-Derived Product or a
Monoclonal Antibody Product for In
Vivo Use
Draft Guidance for Industry: September 20, 1996 Do Do
Manufacture, Processing or Holding of
Active Pharmaceutical Ingredients
Draft Guidance for Industry; November 4, 1996 Do Do
Submitting Application Archival
Copies in Electronic Format
Draft Guidance for Industry; November 4, 1996 Do Do
Electronic Submission of Case Report
Forms and Case Report Tabulations
Guidance for the Submission of January 10, 1997 Do Do
Chemistry, Manufacturing, and
Controls Information and
Establishment Description for
Autologous Somatic Cell Therapy
Products
Proposed Approach to Regulation of February 28, 1997 Do Do
Cellular and Tissue-Based Products
Tables 1 and 2 from Proposed Approach March 4, 1997 Do Do
to Regulation of Cellular and Tissue-
Based Products
Guidance for Industry-FDA Approval of March 13, 1997 Do Do
New Cancer Treatment Uses for
Marketed Drug and Biological Products
Guidance for Industry-Providing March 13, 1997 Do Do
Clinical Evidence of Effectiveness
for Human Drug and Biological
Products
Guidance for Industry for the April 10, 1997 Do Do
Evaluation of Combination Vaccines
for Preventable Diseases: Production,
Testing and Clinical Studies
Guidance for Industry--Changes to an July 24, 1997 Do Do
Approved Application: Biological
Products
Guidance for Industry--Changes to an July 24, 1997 Do Do
Approved Application for Specified
Biotechnology and Specified Synthetic
Biological Products
Guidance for Industry--Screening and July 29, 1997 Do Do
Testing of Donors of Human Tissue
Intended for Transplantation
[[Page 9800]]
Guidance for Industry--Donor Screening August 15, 1997 Do Do
for Antibodies to HTLV-II
Guidance for Industry on Testing August 25, 1997 Do Do
Limits in Stability Protocols for
Standardized Grass Pollen Extracts
Guidance for Industry - Postmarketing August 27, 1997 Do Do
Adverse Experience Reporting for
Human Drug and Licensed Biological
Products: Clarification of What to
Report
Guidance for Industry Efficacy September 1, 1997 Do Do
Evaluation of Hemoglobin-and
Perfluorocarbon-Based Oxygen Carriers
Guidance for Industry--The Sourcing October 7, 1997 Do Do
and Processing of Gelatin to Reduce
the Potential Risk Posed by Bovine
Spongiform Encephalopathy (BSE) in
FDA-Regulated Products for Human Use
Draft Guidance for Industry--For December 29, 1997 Do Do
Submission of Chemistry,
Manufacturing and Controls and
Establishment Description Information
for Human Plasma-Derived Biological
Products or Animal Plasma or Serum-
Derived Products
FDA's Policy Statement Concerning November 25, 1992 Do Do
Cooperative Manufacturing
Arrangements for Licensed Biologics
FDA Guidance Document Concerning Use July 11, 1995 Do Do
of Pilot Manufacturing Facilities for
the Development and Manufacture of
Biological Products; Availability
Changes to be Reported for Product and April 6, 1995 Do Do
Establishment License Applications;
Guidance
Advertising and Promotion; Guidance; October 8, 1996 Do Do
Notice
Interpretative Guidelines of the October 2, 1973 Do Do
Source Plasma (Human) Standards
Guidelines for Reviewing Amendments to July 20, 1976 Do Do
Include Plasmapheresis of
Hemophiliacs
Package Insert: Immune Serum Globulin March 30, 1978 Do Do
(Human)
Guidelines for Interpretation of April 12, 1979 Do Do
Potency Test Results for All Forms of
Adsorbed Diphtheria and Tetanus
Toxoids
Guidelines for Immunization of Source June 1, 1980 Do Do
Plasma (Human) Donors with Blood
Substances
Collection of Human Leukocytes for January 28, 1981 Do Do
Further Manufacturing (Source
Leukocytes)
Platelet Testing Guidelines--Approval July 1, 1981 Do Do
of New Procedures and Equipment
Revised Guideline for Adding Heparin August 1, 1981 Do Do
to Empty Containers for Collection of
Heparinized Source Plasma (Human)
Guidelines for Meningococcal July 17, 1985 Do Do
Polysaccharide Vaccines
Guideline for the Uniform Labeling of August 1, 1985 Do Do
Blood and Blood Components
Guideline for Submitting Documentation February 1, 1987 Do Do
for the Stability of Human Drugs and
Biologics
Guideline for Submitting Documentation February 1, 1987 Do Do
for Packaging for Human Drugs and
Biologics
Guideline On General Principles of May 1, 1987 Do Do
Process Validation
Guideline On Sterile Drug Products June 1, 1987 Do Do
Produced by Aseptic Processing
Guideline On Validation of the Limulus December 1, 1987 Do Do
Amebocyte Lysate Test as an End-
Product Endotoxin Test for Human and
Animal Parenteral Drugs, Biological
Products, and Medical Devices
Revised Guideline for the Collection October 7, 1988 Do Do
of Platelets, Pheresis
Draft Guideline for the Design of November 1, 1988 Do Do
Clinical Trials for Evaluation of
Safety and Efficacy of Allergenic
Products for Therapeutic Uses
Guidelines for Release of Pneumococcal February 1, 1989 Do Do
Vaccine, Polyvalent
FDA Regulated Industries for Drug September 1, 1989 Do Do
Master Files
[[Page 9801]]
FDA Regulated Industries for October 26, 1989 Do Do
Collection of Blood or Blood Products
from Donors With Positive Tests for
Infectious Disease Markers (``High
Risk'' Donors)
Guideline for Determination of January 1, 1990 Do Do
Residual Moisture in Dried Biological
Products
Guideline on the Preparation of March 1, 1991 Do Do
Investigational New Drug Products
(Human & Animal)
Draft Guideline for the Validation of September 28, 1993 Do Do
Blood Establishment Computer Systems
Guideline for Adverse Experience October 15, 1993 Do Do
Reporting for Licensed Biological
Products
Guideline for Quality Assurance in July 11, 1995 Do Do
Blood Establishments
To Biologic Product Manufacturers-- May 3, 1991 Do Do
controlling materials of bovine or
ovine origin
To Sponsors of INDs using Retroviral September 20, 1993 Do Do
Vectors
To Manufacturers: Bovine Derived December 17, 1993 Do Do
Materials (BSE)
To Blood Establishment Computer March 31, 1994 Do Do
Software Manufacturers
To Sponsors of INDs for Human May 23, 1994 Do Do
Immunoglobulin Products
To Manufacturers of Licensed Anti-HIV May 26, 1994 Do Do
Test Kits
To Manufacturers of Immune Globulin December 27, 1994
Products: Testing for Hepatitis C
Virus RNA Immunoglobulin
To Blood Establishment Computer February 10, 1995 Do Do
Software Manufacturers
To Manufacturers of Intramuscular March 3, 1995 Do Do
Immune Globulin Products: HCV RNA
testing by PCR
To Manufacturers of Intramuscular March 13, 1995 Do Do
Immune Globulin Products: Additional
information regarding HCV RNA testing
by PCR
To Health Professionals: March 14, 1995 Do Do
implementation of testing for HCV RNA
by PCR for immune globulin products
for intramuscular administration
Dear Colleague: Regarding Reverse January 4, 1996 Do Do
Transcriptase Activity in Viral
Vaccines Produced in Chicken Cells
To Manufacturers of FDA--Regulated May 9, 1996 Do Do
Drug/Biological/Device Products,
Bovine Spongiform Encephalopathy
(BSE)
To Manufacturers: Implementation of June 13, 1996 Do Do
testing for Hepatitis C virus RNA by
polymerase chain reaction (PCR) of
intramuscular immune globulin
preparations
To Manufacturers: HIV-1 Group O July 31, 1996 Do Do
To All Plasma Derivative Manufacturers October 7, 1996 Do Do
and to ABRA: Warning Statement for
Plasma Derivative Product Labeling
To Biologic Product Manufacturers: December 3, 1996 Do Do
Revised procedures for internal
labeling review number assignment
To In Vitro Diagnostic Reagent December 6, 1985 Do Do
Manufacturers: Guidance On the
Labeling of Human Blood Derived In
Vitro Diagnostic Devices In Regard to
Labeling for HTLV-III/LAV Antibody
Testing
PTC in the Manufacture of In Vitro June 20, 1983 Do Do
Monoclonal Antibody Products Subject
to Licensure
Draft PTC in the Production and July 28, 1983 Do Do
Testing of Interferon Intended for
Investigational Use in Humans
(Interferon Test Procedures)
Draft PTC in the Production and April 10, 1985 Do Do
Testing of New Drugs and Biologicals
Produced by Recombinant DNA
Technology
Draft PTC in the Manufacture and August 8, 1989 Do Do
Clinical Evaluation of In Vitro Tests
to Detect Antibodies to Human
Immunodeficiency Virus Type 1 (1989)
PTC in the Collection, Processing and August 22, 1989 Do Do
Testing of Ex Vivo Activated
Mononuclear Leukocytes for
Administration to Humans
[[Page 9802]]
Cytokine and Growth Factor Pre-Pivotal April 2, 1990 Do Do
Trial Information Package
PTC in the Safety Evaluation of August 21, 1990 Do Do
Hemoglobin-Based Oxygen Carriers
Draft PTC in Human Somatic Cell August 27, 1991 Do Do
Therapy and Gene Therapy
PTC in the Design and Implementation March 1, 1992 Do Do
of Field Trials for Blood Grouping
Reagents and Anti-Human Globulin
PTC in the Manufacture of In Vitro March 1, 1992 Do Do
Monoclonal Antibody Products for
Further Manufacturing into Blood
Grouping Reagent and Anti-Human
Globulin
Supplement to the PTC in the April 6, 1992 Do Do
Production and Testing of New Drugs
and Biologicals Produced by
Recombinant DNA Technology: Nucleic
Acid Characterization and Genetic
Stability
Draft PTC in the Characterization of July 12, 1993 Do Do
Cell Lines Used to Produce
Biologicals
PTC in the Manufacture and Testing of August 22, 1995 Do Do
Therapeutic Products for Human Use
Derived from Transgenic Animals
Draft Addendum to the PTC in Human January 2, 1996 Do Do
Somatic Cell and Gene Therapy
PTC on Plasmid DNA Vaccines for December 22, 1996 Do Do
Preventive Infectious Disease
Indications
PTC in the Manufacture and Testing of February 28, 1997 Do Do
Monoclonal Antibody Products for
Human Use
Reviewer Guidance, Computer Software April 26, 1995 FDA Personnel Do
Informed Consent for Plasmapheresis/ October 1, 1995 Do Do
Immunization
Draft Reviewers' Guide: Changes in October 1, 1995 Do Do
Personnel
Disease Associated Antibody Collection October 1, 1995 Do Do
Program
Centerwide Policy on Issuance of and August 20, 1996 Do Do
Response to Clinical Hold Letters for
Investigational New Drug Applications
Reviewer Guidance for a Premarket January 13, 1997 Do Do
Notification Submission for Blood
Establishment Computer Software
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III. Guidance Documents Issued by the Center for Devices and
Radiological Health (CDRH)
----------------------------------------------------------------------------------------------------------------
How to Obtain a Hard Copy of
Grouped by Intended the Document (Name and
Name of Document Date of Issuance User or Regulatory Address, Phone, FAX, E-mail,
Activity or Internet)
----------------------------------------------------------------------------------------------------------------
MDR Reporting Guidance For Breast August 7, 1996 Office of Division of Small
Implants--E1996002 Surveillance and Manufacturers Assistance, 1-
Biometrics (OSB) 800-638-2041 or 301-827-0111
or (Fax) Facts on Demand at
1-800-899-0381 or Internet
at http://www.fda.gov/cdrh
Instructions for Completing Form 3417: March 31, 1987 OSB Do
Medical Device Reporting Baseline
Report [MDR]
MDR Guidance Document No. 1--IOL-- August 7, 1996 Do Do
E1996004
MDR Guidance Document No. 3-- August 9, 1996 Do Do
Needlestick & Blood Exposure--
E1996003
Statistical Guidance for Clinical January 1, 1996 Do Do
Trials of Non Diagnostic Medical
Devices (Replaces Clinical Study
Guidance)
Medical Device Reporting: An Overview April 1996 Do Do
Instructions for Completing FDA Form December 15, 1995 Do Do
3500A with Coding Manual for Form
3500A (MEDWATCH)
MEDWATCH FDA Form 3500A for Use by June 1, 1993 Do Do
User Facilities, Distributors, and
Manufacturers for Mandatory Reporting
[[Page 9803]]
Amendment to Guidance on Discretionary March 30, 1994 Do Do
Postmarket Surveillance on Pacemaker
Leads
Proposed Draft Guidance to Sponsors October 7, 1994 Do Do
Regarding Required Postmarket
Surveillance Studies of Plasma--
Sprayed Porous-Coated Hip Prostheses
Required Postmarket Surveillance July 31, 1997 Do Do
Section 522(a) Initial Device
Categories Revised
MDR Guidance Document: Remedial Action July 30, 1996 Do Do
Exemption--E1996001
MDR Internet List Server (listserv) August 29, 1996 Do Do
Instruction sheet
Semi-Annual Report, Form 3419 (MDR) September 24, 1996 Do Do
Variance from Manufacturer Report July 16, 1996 Do Do
Number Format (MDR letter)
Guidance to Manufacturers on the November 8, 1991 Do Do
Development of Required Postmarket
Surveillance Study Protocols Under
Section 522(a)(1) of the Federal
Food, Drug, and Cosmetic Act
Medical Device Reporting for April 1996 Do Do
Distributors
Medical Device Reporting for March 1997 Do Do
Manufacturers
Guidance to Sponsors on the June 9, 1993 Do Do
Development of a Discretionary
Postmarket Surveillance Study for
Permanent Implantable Cardiac
Pacemaker Electrodes (Leads)
Instructions for Completing Semi- September 24, 1996 Do Do
Annual Report, Form 3419 (MDR)
Variance from Manufacturer Report August 12, 1996 Do Do
Number Format
Variance from Manufacturer Report July 16, 1996 Do Do
Number Format
Statistical Aspects of Submissions to June 1, 1984 Do Do
FDA: A Medical Device Perspective
(also includes as Appendix the
article Observed Uses and Abuses of
Statistical Procedures in Medical
Device
Investigational Device Exemptions June 1, 1996 Office of Health and Do
[IDE] Manual (FDA 96-4159)/DSMA Industry Programs
(OHIP), Division of
Small Manufacturer's
Assistance (DSMA)
Additional Guidance for Testing September 1, 1993 Do Do
Immunity to Radiated Electromagnetic
Fields--Infant Apnea Monitor Standard
Premarket Approval (PMA) Manual (FDA April 1, 1993 Do Do
93-4214)
Comparison Chart: 1996 Quality System Do Do
Reg vs. 1978 Good Manufacturing
Practices Reg vs. ANSI/ISO/ASQC Q9001
and ISO/DI 13485:1996 (include 126)
Obtaining CDRH Guidance Documents October 21, 1997 Do Do
Regulatory Requirements for Devices August 1, 1987 Do Do
for the Handicapped (FDA 87-4221)
Small Business Guide to FDA (FDA 96- January 1, 1996 Do Do
1092)
MDR Documents Access Information May 10, 1996 Do Do
MDR Documents Access Information for February 29, 1996 Do Do
CDRH Electronic Docket (ED)
MDR Documents Access Information for February 29, 1996 Do Do
CDRH Facts-On-Demand (FOD)
MDR Documents Access Information for May 8, 1996 Do Do
Industry Organizations
MDR Documents Access Information for May 10, 1996 Do Do
National Technical Information
Service (NTIS)
MDR Documents Access Information for February 29, 1996 Do Do
World Wide Web (WWW)
Addendum to What a Mammography July 31, 1996 OHIP/Division of MQSA
Facility Should do to Prepare for an Mammography Quality
MQSA Inspection and Radiation
Programs (DMQRP)/
Mammography Quality
Standards Act (MQSA)
Handbook of Selected Tissue Doses for September 1, 1995 Do Do
Fluoroscopic and Cineangiographic
Examination of the Coronary Arteries
(in SI Units) FDA 95-8289, (Units of
milliray (mmmGy) tissue
Policy Statements in Question and October 7, 1997 Do Do
Answer Format
[[Page 9804]]
What a Mammography Facility Should Do June 30, 1995 Do Do
to Prepare for an MQSA Inspection
Classification Names for Medical March 1, 1995 Do Do
Devices and In Vitro Diagnostic
Products (FDA Pub No. 95-4246)
Import of Medical Devices--A Workshop March 1, 1993 Do Do
Manual (FDA 93-4228)
Labeling--Regulatory Requirements for September 1, 1989 Do Do
Medical Devices (FDA 89-4203)
List of Current CDRH Addresses for July 30, 1996 Do Do
Report Submission and Ordering of
CDRH Forms
Premarket Notification: 510(k)-- August 1, 1995 Do Do
Regulatory Requirements for Medical
Devices (FDA 95-4158)
Procedures for Laboratory Compliance May 1, 1986 Do Do
Testing of Television Receivers--part
of TV Packet
U.S. Food and Drug Administration May 1, 1996 Do Do
Regulation of Medical Devices--
Background Information for Foreign
Officials
Instructions for Completion of Medical July 1, 1997 Do Do
Device Registration and Listing Forms
FDA 2891, 2891a and 2892
In Vitro Diagnostic Devices: Guidance January 1, 1997 Do Do
for the Preparation of 510(k)
Submissions (supersedes FDA 87-4224)
An Introduction to Medical Device January 1, 1992 Do Do
Regulations (FDA 92-4222)
Do It By Design--An Introduction to December 1, 1996 OHIP/Division of Do
Human Factors in Medical Devices Device User Programs
and Systems Analysis
(DDUPSA)
Good Guidance Practices Standard October 17, 1997 Do .............................
Operating Procedures Manual for the
Development and Use of Guidance
Documents in CDRH
Human Factors Principles for Medical September 1, 1993 Do Do
Device Labeling
Medical Device Reporting for User April 1996 Do Do
Facilities
Write it Right August 1, 1993 Do Do
Human Factors Points to Consider for January 17, 1997 Do Do
IDE Devices
Medical Devices and EMI: The FDA January 1, 1995 Office of Compliance Do
Perspective
Enforcement Policy; Recalls (Including June 16, 1978 Do Do
Product Corrections)--Guidelines on
Policy; Procedures; and Industry
Responsibilities
Sec. 300.600 Commercial Distribution September 24, 1987 Do Do
with Regard to Premarket Notification
[Section 510(k)] [CPG 7124.19]
Procedures for Obtaining FDA Approval January 13, 1995 Do
to Export Unapproved Medical Devices
The FDA Export Reform and Enhancement October 1, 1996 Do Do
Act of 1996/Export Certification
FDA Regulatory Procedures Manual May 23, 1991 Do Do
Chapter 8-10 Warning Letters
A Pocket Guide to Device GMP November 1, 1991 Do Do
Inspections--Inspections of Medical
Device Manufacturers and GMP
Regulation Requirements
Commercial Distribution/Exhibit Letter April 10, 1992 Do Do
(Use instead of Hile letter)
(Display)
Diagnostic Ultrasound Guidance Update January 30, 1987 Office of Compliance Do
(OC)/Division of
Enforcement I (DOE
I)
Doppler Ultrasound Guidance Update March 7, 1986 Do Do
Manufacturers/Assemblers of Diagnostic October 13, 1993 Do Do
X-ray Systems: Enforcement Policy for
Positive-Beam Limitation (PBL)
Requirements in 21 CFR 1020.31(g)
A Guide for the Submission of March 1, 1996 Do Do
Abbreviated Radiation Safety Reports
on Cephalometric X-Ray Devices:
Defined as Dental Units with an
Attachment for Mandible Work that
Holds a
A Guide for the Submission of March 1, 1996 Do Do
Abbreviated Radiation Safety Reports
on Image Receptor Support Devices for
Mammographic X-Ray Systems
[[Page 9805]]
A Guide for the Submission of an March 1, 1996 Do
Abbreviated Radiation Safety Report
on X-Ray Tables, Cradles, Film
Changers or Cassette Holders Intended
for Diagnostic Use
All Diagnostic Ultrasound February 24, 1986 Do Do
Manufacturers and Importers-Exemption
from Reporting under 21 CFR 1002
Clarification of Radiation Control March 1, 1989 Do Do
Regulations for Diagnostic X-Ray
Equipment (FDA 89-8221)
Guide for the Submission of Initial January 1, 1982 Do Do
Reports on Diagnostic X-Ray Systems
and their Major Components
Letter to Medical Device Industry on May 17, 1993 Do Do
Endoscopy and Laparoscopy Accessories
(Galdi)
Medical Device Tracking: Questions and August 26, 1993 Do Do
Answers Based on the Final Rule
Guideline for the Manufacture of In January 10, 1994 Do Do
Vitro Diagnostic Products
Retention of Records Required by 21 August 24, 1981 Do Do
CFR 1002
Letter to Manufacturers/Repackers April 22, 1994 OC/Division of Do
Using Cotton Enforcement II (DOE
II)
Condoms: Inspection and Sampling at April 8, 1987 Do Do
Domestic Manufacturers and of all
Repackers; Sampling from all
Importers (Damaska Memo to Field on 4/
8/87)
Hazards of Volume Ventilators and September 15, 1993 Do Do
Heated Humidifiers
Compliance Guide for Laser Products September 1, 1985 Do Do
(FDA 86-8260)
Dental Handpiece Sterilization (Dear September 28, 1992 Do Do
Doctor Letter)
Ethylene Oxide; Ethylene Chlorohydrin; June 23, 1978 Do Do
and Ethylene Glycol; Proposed Maximum
Residue Limits and Maximum Levels of
Exposure
GLOVES Information About Medical September 1, 1993 Do Do
Gloves
Letter--Manufacturers, Distributors February 23, 1994 Do Do
and Importers of Condom Products
[included in Condom Packet #398]
Letter--Manufacturers, Importers, and February 13, 1989 Do Do
Repackagers of Condoms for
Contraception or Sexually-Transmitted
Disease Prevention (Holt) [included
in Condom Packet #398]
Pesticide Regulation Notice 94-4: June 30, 1994 Do Do
Interim Measures for the Registration
of Antimicrobial Products/Liquid
Chemical Germicides with Medical
Device Use Claims Under the
Regulatory Requirements for Medical September 1, 1996 Do Do
Gloves--A Workshop Manual FDA
Publication No. 96-4257
Standard Specification for Rubber October 28, 1983 Do Do
Contraceptives (Condoms) [included in
Condom Packet #398]
Sterilization: Questions and Answers January 1, 1985 Do Do
from FDA, from Medical Device and
Diagnostic Industry for January,
1985, page 132
All U.S. Condom Manufacturers, April 7, 1987 Do Do
Importers and Repackagers
Letter to Ophthalmologists about June 27, 1997 Do Do
Lasers for Refractive Surgery
Manufacturers and Initial Distributors May 23, 1996 Do Do
of Hemodialyzers
Manufacturers and Users of Lasers for October 10, 1996 Do Do
Refractive Surgery
Manufacturers of Laparoscopic Trocars, August 23, 1996 Do Do
used for Abdominal Access
Prospective Manufacturers of Barrier October 31, 1996 Do Do
Devices used during Oral Sex for STD
Protection
Impact Resistant Lenses: Questions and September 1, 1987 Do Do
Answers (FDA 87-4002) [see shelf--#
460]
Letter to Industry, Powered Wheelchair May 10, 1993 Do Do
Manufacturers from RMJohnson
[[Page 9806]]
Manufacturers and Initial Distributors February 3, 1994 Do Do
of Sharps Containers and Destroyers
Used by Health Care Professionals
Guide for Preparing Product Reports September 1, 1995 Do Do
for Lasers and Products Containing
Lasers
Letter--Condom Manufacturers and April 5, 1994 Do Do
Distributors
Suggested State Regulations for January 1, 1982 OC/Division of Do
Control of Radiation--Volume II Enforcement III (DOE
Nonionizing Radiation--Lasers (FDA III)
Pub No. 83-8220)
Quality Assurance Guidelines for February 1, 1991 Do Do
Hemodialysis Devices
Quality Control Guide for Sunlamp March 1, 1988 Do Do
Products (FDA 88-8234)
Quality Control Practices for May 1, 1980 Do Do
Compliance with the Federal Mercury
Vapor Lamp Performance Standard
Reporting and Compliance Guide for October 1, 1995 Do Do
Television Products including Product
Report, Supplemental Report,
Radiation Safety Abbreviated Report,
Annual Report, Informational Guidance
Policy on Lamp Compatibility September 2, 1986 Do Do
(sunlamps)
Policy on Maximum Timer Interval and August 21, 1986 Do Do
Exposure Schedule for Sunlamp
Products
Policy on Warning Label Required on June 25, 1985 Do Do
Sunlamp Products
Imports Radiation-Producing Electronic November 1, 1988 Do Do
Products (FDA 89-8008)
Information Requirements for Cookbooks October 31, 1988 Do Do
and User and Service Manuals
Keeping Up With the Microwave March 1, 1990 Do Do
Revolution (FDA Pub No. 91-4160)
Laser Light Show Safety--Who's May 1, 1986 Do Do
Responsibility (FDA 86-8262)
Letter to All Foreign Manufacturers May 28, 1981 Do Do
and Importers of Electronic Products
for Which Applicable FDA Performance
Standards Exist
General Principles of Software June 9, 1997 Do Do
Validation; Draft Guidance
Reporting Guide for Laser Light Shows September 1, 1995 Do Do
and Displays (21 CFR 1002) (FDA 88-
8140)
Reporting Guide for Product Reports on September 1, 1995 Do Do
High Intensity Mercury Vapor
Discharge Lamps (21 CFR 1002)
Revised Guide for Preparing Annual September 1, 1995 Do Do
Reports on Radiation Safety Testing
of Laser and Laser Light Show
Products (replaces FDA 82-8127)
Safety of Electrically Powered September 18, 1996 Do Do
Products: Letter To Medical Device
and Electronic Product Manufacturers
From Lillian Gill & BHB correction
memo
Unsafe Patient Lead Wires and Cables September 3, 1993 Do Do
Design Control Guidance for Medical March 11, 1997 Do Do
Device Manufacturers
Final Design Control Inspectional March 1, 1997 Do Do
Strategy
Guide for Preparing Abbreviated September 1, 1996 Do Do
Reports of Microwave and RF Emitting
Electronic Products Intended for
Medical Use
Guide for Preparing Annual Reports for September 1, 1996 Do Do
Ultrasonic Therapy Products
Guide for Preparing Product Reports September 1, 1996 Do Do
for Medical Ultrasound Products
Guide for Preparing Product Reports August 1, 1996 Do Do
for Ultrasonic Therapy Products
(physical therapy only)
Application for a Variance from 21 CFR March 1, 1987 Do Do
1040.11(c) for a Laser Light Show,
Display, or Device
Letter to Trade Association: ReUse of December 27, 1995 Do Do
Single-use or Disposable Medical
Devices
Letter: Changes in Regulations October 27, 1995 Do Do
Concerning Records and Reports on
Radiation-Emitting Electronic
Products
[[Page 9807]]
Medical Device Electromagnetic Do Do
Interference Issues, Problem Reports,
Standards, and Recommendations
Computerized Devices/Processes May 1, 1992 Do Do
Guidance--Application of the Medical
Device GMP to Computerized Devices
and Manufacturing Processes
Keeping Medical Devices Safe from July 1, 1995 Do Do
Electromagnetic Interference
Latex Labeling Letter (Johnson) Do Do
Guide for Preparing Annual Reports on September 1, 1995 Do Do
Radiation Safety Testing of Mercury
Vapor Lamps (replaces FDA 82-8127)
Guide for Preparing Annual Reports on September 1, 1995 Do Do
Radiation Safety Testing of Sunlamps
and Sunlamp Products (replaces FDA 82-
8127)
Guide for Preparing Product Reports on September 1, 1995 Do Do
Sunlamps and Sunlamp Products (21 CFR
1002)
Abbreviated Reports on Radiation August 1, 1995 Do Do
Safety for Microwave Products (Other
Than Microwave Ovens)--e.g.,
Microwave Heating, Microwave
Diathermy, RF Sealers, Induction,
Dielectric
Abbreviated Reports on Radiation August 1, 1995 Do Do
Safety of Non-Medical Ultrasonic
Products
Guidance for the Submission of Cabinet February 1, 1975 Do Do
X-Ray System Reports Pursuant to 21
CFR 1020.40
Guide for Preparing Annual Reports on October 1, 1987 Do Do
Radiation Safety Testing of
Electronic Products (General)
Guide for Preparing Initial Reports April 1, 1989 Do Do
and Model Change Reports on Medical
Ultraviolet (UV) Lamps and Products
Containing Such Lamps (21 CFR 1002.10
and 1002.12)
Guide for Preparing Reports on March 1, 1985 Do Do
Radiation Safety of Microwave Ovens
Guide for Submission of Information on April 1, 1971 Do Do
Accelerators Intended to Emit X-
Radiation Required Pursuant to 21 CFR
1002.10
Guide for Submission of Information on April 30, 1974 Do Do
Analytical X-Ray Equipment Required
Pursuant to 21 CFR 1002.10
Guide for Submission of Information on September 1, 1980 Do Do
Industrial Radiofrequency Dielectric
Heater and Sealer Equipment Pursuant
to 21 CFR 1002.10 and 1002.12 (FDA 81-
8137)
Guide for Submission of Information on March 1, 1973 Do Do
Industrial X-Ray Equipment Required
Pursuant to 21 CFR 1002.10
Guide for the Filing of Annual Reports July 1, 1980 Do Do
for X-Ray Components and Systems
Guide for the Submission of Initial September 1, 1984 OC/DOE I and III Do
Reports on Computed Tomography X-Ray
Systems
Additional Information for Initial April 9, 1993 Do Do
Reports
All Diagnostic Ultrasound February 24, 1986 Do Do
Manufacturers and Importers Exemption
from Reporting under 21 CFR 1002
Guideline for Preparing Notices of November 1, 1985 OC/Bioresearch Do
Availability of Investigational Monitoring (BIMO)
Medical Devices
Recommended Test Methods Infant Apnea September 1, 1993 Office of Standards Do
Monitor Standard and Technology (OST)
Draft Document--A Primer on Medical February 7, 1997 Do Do
Device Interactions with Magnetic
Resonance Imaging Systems
Letter to Medical Device Manufacturer February 14, 1995 CDRH, Office of the Do
on Pentium Processors Director (OD)
``Real-Time'' Review Program for April 22, 1997 Office of Device Do
Premarket Approval Application (PMA) Evaluation (ODE)
Supplements
A New 510(k) Paradigm--Alternate June 13, 1997 Do Do
Approaches to Demonstrating
Substantial Equivalence in Premarket
Notifications
Freedom of Information/510(K) Process May 15, 1997 Do Do
Changes
[[Page 9808]]
Reexamination of the Evaluation May 19, 1997 Do Do
Process for Liquid Chemical Sterilant
and High Level Disinfectants
Center for Devices and Radiological June 30, 1993 Do Do
Health's Investigational Device
Exemption (IDE) Refuse to Accept
Policy
Center for Devices and Radiological June 30, 1993 Do Do
Health's Premarket Notification
[510(k)] Refuse to Accept Policy--
(updated Checklist 3/14/1995)
4-of-A-Kind PMA's October 1, 1991 Do Do
Application of the Device Good December 1, 1983 Do Do
Manufacturing Practice (GMP)
Regulation to the Manufacture of
Sterile Devices
Biotechnology and FDA Regulation of January 1, 1986 Do Do
Hybridoma In-Vitro Diagnostic
Products: List of Current Devices and
Guidelines for Manufacturers
CDRH's 510(k)/IDE/PMA Refuse to Accept/ June 30, 1993 Do Do
Accept/File Policies (see #D94-1,
#K94-1, & #P94-1)
Classified Convenience Kits April 30, 1993 Do Do
Color Additive Petitions (p. II-19 of June 1, 1987 Do Do
PMA Manual)
Color Additive Status List (Inspection February 1, 1989 Do Do
Operations Manual)
Color Additives for Medical Devices November 15, 1995 Do Do
(Snesko)
Deciding When to Submit a 510(k) for a January 10, 1997 Do Do
Change to an Existing Device [see
CDRH F-O-D #1935]
Device Specific Guidance Documents May 11, 1993 Do Do
(List)
FDA Clinical Investigator Information May 1, 1989 Do Do
Sheets
FDA Guide for Validation of Biological January 1, 1986 Do Do
Indicator Incubation Time (Source:
Sterilization Committee; through
Virginia Ross; HFZ-332)
FDA Policy For The Regulation Of November 13, 1989 Do Do
Computer Products (DRAFT) [See 2099]
Format for IDE Progress Reports Do Do
Guidance for Preparation of PMA August 1, 1992 Do Do
Manufacturing Information
Guide for Establishing and Maintaining March 1, 1988 Do Do
a Calibration Constancy
Intercomparison System for Microwave
Oven Compliance Survey Instruments
(FDA 88-8264)
Guideline for the Monitoring of January 1, 1988 ODE Do
Clinical Investigations
Guideline on General Principles of May 1, 1987 Do Do
Process Validation
Guideline on Sterile Drug Products June 1, 1987 Do Do
Produced by Aseptic Processing
Guideline on Validation of the Limulus December 1, 1987 Do Do
Amebocyte Lysate (LAL) Test as an End-
Product Endotoxin Test
Indications for Use Statement January 2, 1996 Do Do
Industry Representatives on Scientific March 27, 1987 Do Do
Panels
Labeling Reusable Medical Devices for April 1, 1996 Do Do
Reprocessing in Health Care
Facilities: FDA Reviewer Guidance
(see 1198)
Limulus Amebocute Lysate; Reduction of October 23, 1987 Do Do
Samples for Testing
Master Files Part III; Guidance on June 1, 1987 Do Do
Scientific and Technical Information
Memorandum: Electromagnetic June 13, 1995 Do Do
Compatibility for Medical Devices:
Issues and Solutions
Methods for Conducting Recall June 16, 1978 Do Do
Effectiveness Checks
Necessary Information for Diagnostic November 24, 1987 Do Do
Ultrasound 510(k) (Draft)
Perspectives on Clinical Studies for Do Do
Medical Device Submissions
(Statistical)
PMA Review Schedule March 31, 1988 Do Do
PMA Review Statistical Checklist Do Do
Points to Consider in the June 1, 1984 Do Do
Characterization of Cell Lines Used
to Produce Biological Products (from
John C. Petricciani, M.D.)
Preamendment Class III Devices March 11, 1992 Do Do
[[Page 9809]]
Premarket Notification [510(k)] Status March 7, 1994 Do Do
Request Form, revised
Premarket Submission Coversheet, January 19, 1995 Do Do
Instructions, and Survey
Preproduction Quality Assurance September 1, 1989 Do Do
Planning: Recommendations for Medical
Device Manufacturers (FDA 90-4236)
Proposal for Establishing Mechanisms June 30, 1993 Do Do
for Setting Review Priorities Using
Risk Assessment and Allocating Review
Resources (include with 926-930)
Questions and Answers for the FDA September 3, 1996 Do Do
Reviewer Guidance: Labeling Reusable
Medical Devices for Reprocessing in
Health Care Facilities
Reviewer Guidance for Computer August 29, 1991 Do Do
Controlled Medical Devices Undergoing
510(k) Review
Shelf Life of Medical Devices March 1, 1991 Do Do
Substantial Equivalence (SE) Decision January 1, 1990 Do Do
Making Documentation ATTACHED: ``SE''
Decision Making Process (Detailed)
i.e. the decision making tree
Suggested Content for Original IDE February 27, 1996 Do Do
Application Cover Letter--Version 4
Suggestions for Submitting a Premarket April 1, 1993 Do Do
Approval (PMA) Application
Threshold Assessment of the Impact of January 1, 1990 Do Do
Requirements for Submission of PMA's
for 31 Medical Devices Marketed Prior
to May 28, 1976
Viable Bacteriophage in Co2 Laser Do Do
Plume: Aerodynamic Size Distribution
Drugs of Abuse Screening Test Devices July 21, 1987 Do Do
Letter--Vascular Graft Industry November 22, 1995 Do Do
(Philip Phillips)
Letter to Industry, Powered Wheelchair/ May 26, 1994 Do Do
Scooter or Accessory/Component
Manufacturer from Susan Alpert,
Ph.D.,M.D.
Preamendments Class III Strategy; April 19, 1994 Do Do
SXAlpert
Draft Guidance to Firms on Biliary August 2, 1990 ODE/Division of Do
Lithotripsy Studies Reproductive,
Abdominal, ENT, and
Radiological Devices
(DRAERD)
Letter: Notice to Manufacturers of September 25, 1997 Do Do
Bone Mineral Densitometers
510(k) Checklist for Sterile September 19, 1994 Do Do
Lubricating Jelly Used With
Transurethral Surgical Instruments
CDRH Interim Regulatory Policy for September 10, 1997 Do Do
External Penile Rigidity Devices
Checklist for Mechanical Lithotripters November 1, 1994 Do Do
and Stone Dislodgers used in
Gastroenterology and Urology
Draft--510(k) Checklist for November 23, 1994 Do Do
Conditioned Response Enuresis Alarms
Draft 510(k) Checklist for Condom February 23, 1995 Do Do
Catheters
Draft 510(k) Checklist for Endoscopic August 16, 1995 Do Do
Electrosurgical Unit (ESU) and
Accessories Used in Gastroenterology
and Urology
Draft 510(k) Checklist for Endoscopic June 22, 1995 Do Do
Light Sources Used in
Gastroenterology and Urology
Draft 510(k) Checklist for Non- June 6, 1995 Do Do
Implanted Electrical Stimulators Used
for the Treatment of Urinary
Incontinence
Draft 510(k) Checklist for Urological August 1, 1995 Do Do
Irrigation System and Tubing Set
Draft Guidance for Clinical November 11, 1994 Do Do
Investigations of Devices Used for
the Treatment of Benign Prostatic
Hyperplasia (BPH)
Draft Guidance for Information on February 5, 1992 Do Do
Clinical Safety and Effectiveness
Data for Extracorporeal Shock Wave
Lithotripsy of Upper Urinary Tract
(Renal Pelvis, Renal)
Draft Guidance for Preclinical and November 29, 1995 Do Do
Clinical Investigations of Urethral
Bulking Agents Used in the Treatment
of Urinary Incontinence
[[Page 9810]]
Draft Guidance for Preparation of PMA March 16, 1993 Do Do
Applications for Penile Inflatable
Implants
Draft Guidance for Preparation of PMA March 16, 1993 Do Do
Applications for Testicular
Prostheses
Draft Guidance for Preparation of PMA May 1, 1995 Do Do
Applications for the Implanted
Mechanical/Hydraulic Urinary
Continence Device (Artificial Urinary
Sphincter)
Draft Guidance for the Clinical November 2, 1995 Do Do
Investigation of Urethral Stents
Draft Guidance for the Content of March 17, 1995 Do Do
Premarket Notifications for
Endoscopes used in Gastroenterology
and Urology
Draft Guidance for the Content of May 30, 1995 Do Do
Premarket Notifications for Penile
Rigidity Implants
Draft Guidance for the Content of January 24, 1992 Do Do
Premarket Notifications for
Urological Balloon Dilatation
Catheters
Draft Guidance Outline--Points to November 30, 1993 Do Do
Consider for Clinical Studies for
Vasovasostomy Devices
Guidance for the Content of Premarket February 10, 1993 Do Do
Notifications for Biopsy Devices Used
in Gastroenterology and Urology
Guidance for the Content of Premarket September 12, 1994 Do Do
Notifications for Conventional and
Antimicrobial Foley Catheters
Guidance for the Content of Premarket February 10, 1993 Do Do
Notifications for Ureteral Stents
Guidance for the Content of Premarket June 7, 1994 Do Do
Notifications for Urine Drainage Bags
Guidance for the Content of Premarket July 29, 1994 Do Do
Notifications for Urodynamic/
Uroflowmetry Systems
Guidance to Manufacturers on the Do Do
Development of Required Postapproval
Epidemiologic Study Protocols for
Testicular Implants
510(k) Guide for Measuring and December 1, 1985 Do Do
Reporting Acoustic Output of
Diagnostic Ultrasound Medical Devices
Draft Guidance for Review of Bone November 9, 1992 Do Do
Densitometer 510(k) Submissions
Draft MRI Guidance Update for dB/dt October 11, 1995 Do Do
[update, include with 8/2/88
document]
Guidance for Magnetic Resonance September 29, 1997 Do Do
Diagnostic Devices--Criteria for
Significant Risk Investigations
Guidance for the Comment and Review of August 1, 1993 Do Do
510(k) Notifications for Picture
Archiving and Communications Systems
(PACS) and Related Devices [See 2099]
Guidance for the Submission of 510(k)s June 1, 1997 Do Do
for Solid State X-Ray Imaging Devices
Information for Manufacturers Seeking April 11, 1997 Do Do
Marketing Clearance of Diagnostic
Ultrasound Systems and Transducers
Information for Manufacturers Seeking June 19, 1996 Do Do
Marketing Clearance of Digital
Mammography Systems
Reviewer Guidance for Automatic X-Ray February 1, 1990 Do Do
Film Processor 510(k)
Simplified 510(k) procedures for 1994 Do Do
certain radiology devices:3 letters
12/21/93; 1/31/94 and 3/31/94
ORDB 510(k) Sterility Review Guidance July 3, 1997 Do Do
Condom Packet: 4/13/94 RJRivera April 13, 1994 Do Do
Letter, Condom Guidance & 7 Tabs,
General Guidance for Modifying Condom
Labeling to Include Shelf Life
Draft Guidance for the Content of July 29, 1991 Do Do
Premarket Notifications for Loop and
Rollerball Electrodes for GYN
Electrosurgical Excisions
Draft Guidance for the Content of May 25, 1995 Do Do
Premarket Notifications for Menstrual
Tampons
Draft Thermal Endometrial Ablation March 14, 1996 Do Do
Devices (Submission Guidance for an
IDE)
Guidance (``Guidelines'') for March 8, 1977 Do Do
Evaluation of Fetal Clip Electrode
[[Page 9811]]
Guidance (``Guidelines'') for May 10, 1978 Do Do
Evaluation of Hysteroscopic
Sterilization Devices
Guidance (``Guidelines'') for Do Do
Evaluation of Laparoscopic Bipolar
and Thermal Coagulators (and
Accessories)
Guidance (``Guidelines'') for November 22, 1977 Do Do
Evaluation of Tubal Occlusion Devices
Guidelines for Evaluation of Non-Drug September 28, 1976 Do Do
IUD's
Hysteroscopes and Gynecology March 27, 1996 Do Do
Laparoscopes--Submission Guidance for
a 510(k)--includes 00192
Hysteroscopes and Laparoscopic August 1, 1995 Do Do
Insufflators: Submission Guidance for
a 510(k)
In-vivo Devices for the Detection of June 14, 1997 Do Do
Cervical Cancer and its Precursors:
Submission Guidance for an IDE Draft
Document
Intrapartum Continuous Monitors for June 14, 1997 Do Do
Fetal Oxygen Saturation and Fetal pH;
Submission Guidance for a PMA; Draft
Document
Premarket Testing Guidelines for November 20, 1992 Do Do
Falloposcopes
510(k) Diagnostic Ultrasound Guidance4/ February 1993 Do Do
91 Use of Medical Index in Place of
Spatial Peak Intensity in Determining
Substantial Equival for Diagnostic
Ultrasound Equip/Access/Rel Meas. Dev
Premarket Testing Guidelines for April 4, 1990 Do Do
Female Barrier Contraceptive Devices
also intended to prevent sexually
transmitted diseases
Premarket Testing Guidelines for Home March 31, 1993 Do Do
Uterine Activity Monitors
Testing guidance for Male Condoms Made June 29, 1995 Do Do
from New Material (Non-Latex)
Information for a Latex Condom 510K March 1994 Do Do
Subm. for Obstetrics-Gynecology
Branch (draft)
Guidance for Content and Review of a October 11, 1995 Do Do
Magnetic Resonance Diagnostic Device
510(k) Applic.
Draft Guidance for Hemodialyzer Reuse October 6, 1995 Do Do
Labeling
Draft Guidance for the Content of May 30, 1997 Do Do
Premarket Notifications for Water
Purification Components and Systems
for Hemodialysis
Guidelines for Premarket Testing of March 1, 1982 Do Do
New Conventional Hemodialyzers, High
Permeability Hemodialyzers, and
Hemofilters
Draft of Suggested Information for January 1, 1991 Do Do
Reporting Extracorporeal Shock Wave
Lithotripsy Device Shock Wave
Measurements
Draft Guidance to Hearing Aid August 5, 1994 Do Do
Manufacturers for Substantiation of
Claims
Guidance for Submission of a 510(k) April 1, 1991 Do Do
Premarket Notification for an Air
Conduction Hearing Aid
Guidance For The Arrangement and May 1, 1990 Do Do
Content of a Premarket Approval (PMA)
Application For A Cochlear Implant in
Children Ages 2 through to 17 Years
Guidance for the Content of Premarket October 21, 1996 Do Do
Notification for Disposable, Sterile,
Ear, Nose and Throat Endoscope
Sheaths with Protective Barrier
Claims
Guideline for the Arrangement and May 1, 1990 Do Do
Content of a Premarket Approval (PMA)
Application for a Cochlear Implant in
Adults at Least 18 Years of Age
Guidance for the Technical Content of April 1, 1990 Do Do
a Premarket Approval (PMA)
Application for an Endolymphatic
Shunt Tube with Valve
Amendment 1: Draft Premarket June 28, 1994 ODE/Division of Do
Notification [510(k)] Guidance Opthalmics Devices
Document for Class II Daily Wear (DOD)
Contact Lenses
Certification Statement for the Impact .................. Do Do
Resistance Test
Draft Premarket Notification 510(k) May 1, 1997 Do Do
Guidance for Contact Lens Care
Products
[[Page 9812]]
Eye Valve Implant (and all glaucoma November 16, 1995 Do Do
drainage devices) manufacturers
letter from NCBrogdon
FDA Public Health Advisory: Retinal October 16, 1995 Do Do
Photic Injuries from Operating
Microscopes During Cataract Surgery
New FDA Recommendations & Results of May 30, 1989 Do Do
Contact Lens Study (7 day letter)
Sunglass Letter including 510(k) October 8, 1996 Do Do
format
Sunglass Package February 3, 1995 Do Do
Third Party Review Guidance for January 31, 1997 Do Do
Aspiration and Cutting Device
Premarket Notification (510(k))
Third Party Review Guidance for January 31, 1997 Do Do
Phacofragmentation System Device
Premarket Notification (510(k))
Announcement by Dr Alpert at 7/26/96 August 26, 1996 Do Do
Ophthalmic Panel Meeting concerning
Manufacturers & Users of Lasers for
Refractive Surgery [excimer]
Announcement: Information for September 22, 1997 Do Do
Manufacturers & Users of Lasers for
Refractive Surgery [excimer]
Checklist of Information Usually October 10, 1996 Do Do
Submitted in an Investigational
Device Exemptions (IDE) Application
for Refractive Surgery Lasers
[excimer]
Discussion Points for Expansion of the September 5, 1997 Do Do
``Checklist of Information Usually
Submitted in an Investigational
Device Exemption (IDE) Application
for Refractive Surgery Lasers''
Letter to Manufacturers and Users of October 10, 1996 Do Do
Lasers for Refractive Surgery
[excimer]
Owners Certification of Lasers as PMA September 26, 1996 Do Do
Approved Devices [excimer]
Update on Excimer Lasers for May 20, 1996 Do Do
Nearsightedness
Draft Version Guidance for Clinical August 20, 1992 ODE/Division of Do
Data to be Submitted for Premarket General and
Approval Application for Cranial Restorative Devices
Electrotherapy Stimulators (DGRD)
Guidance for the Preparation of August 30, 1994 Do Do
Premarket Notifications for Extended
Laparoscopy Devices
510K Sterility Review Guidance July 3, 1997 Do Do
Technological Reporting for Powered January 1, 1992 Do Do
Muscle Stimulator 510k Submissions
Draft Version Guide for Cortical August 10, 1992 Do Do
Electrode 510(k) Content
Electrical Muscle Stimulator (EMS) July 11, 1985 Do Do
Labeling Indications,
Contraindications, Warnings, etc.
Galvanic Skin Response Measurement August 23, 1994 Do Do
Devices--Draft Guidance for 510 (k)
Content
Guidance Document for the Preparation July 26, 1995 Do Do
for Premarket Notification (510(k))
Applications for Therapeutic
Massagers and Vibrators
Guidance Document for the Preparation August 12, 1988 Do Do
of IDE and PMA Applications for Bone
Growth Stimulator Devices
Guidance Document for the Preparation February 18, 1993 Do Do
of IDE and PMA Applications for Intra-
Articular Prosthetic Knee Ligament
Devices
Guidance Document for the Preparation July 26, 1995 Do Do
of Notification (510(k)) Applications
for Communication Systems (Powered
and Nonpowered) and Powered
Environmental Control
Guidance Document for the Preparation July 26, 1995 Do Do
of Notification (510(k)) Applications
for Electromyograph Needle Electrodes
Guidance Document for the Preparation July 26, 1995 Do Do
of Notification (510(k)) Applications
for Heating and Cooling Devices
Guidance Document for the Preparation July 26, 1995 Do Do
of Notification (510(k)) Applications
for Powered Muscle Stimulators and
Ultrasound Diathermy and Muscle
Stimulator
[[Page 9813]]
Guidance Document for the Preparation July 26, 1995 Do Do
of Notification (510(k)) Applications
for Powered Tables and Multi-function
Physical Therapy Tables
Guidance Document for the Preparation July 26, 1995 Do Do
of Notification (510(k)) Applications
for Submerged (underwater) Exercise
Equipment
Guidance Document for the Preparation July 26, 1995 Do Do
of Notification (510(k)) Applications
of Immersion Hydrobaths
Guidance Document for the Preparation July 26, 1995 Do Do
of Premarket Notification (510(k))
Application for Beds
Guidance Document for the Preparation July 26, 1995 Do Do
of Premarket Notification [510k)]
Applications for Mechanical and
Powered Wheelchairs, and Motorized
Three-Wheeled Vehicles
Guidance for Studies for Pain Therapy May 12, 1988 Do Do
Devices--Gen. Consid. in the Design
of Clinical Studies for Pain-
Alleviating Devices
Guide for TENS 510(k) Content (Draft) August 1, 1994 Do Do
Alternate Suture Labeling Resulting Do Do
from the January 11, 1993 Meeting
with HIMA
Draft Guidance for Preparation of PMA January 18, 1995 Do Do
Applications for Silicone Inflatable
(Saline) Breast Prostheses
Draft Guidance for Preparation of PMA May 11, 1992 Do Do
Submissions of Silicone Gel-Filled
Breast Prosthesis
Draft Guidance for Testing of September 1, 1994 Do Do
Alternative Breast Prostheses
(Nonsilicone Gel-filled)
Draft Guidance for the Preparation of March 31, 1995 Do Do
a Premarket Notification for a Non-
Interactive Wound and Burn Dressing
[510(k)]
Draft Guidance for the Preparation of April 1, 1995 Do Do
IDE Submission for Interactive Wound
and Burn Dressing
Guide for 510(k) Review of Processed June 26, 1990 Do Do
Human Dura Mater
Letter: Core Study for Silicone Breast January 11, 1996 Do Do
Implants
510(k) Information Needed for February 20, 1997 Do Do
Hydroxyapatite Coated Orthopedic
Implants
Draft Guidance for Preparation of FDA May 11, 1992 Do Do
Submissions of Silicone Gel-Filled
Breast Prosthesis
Calcium Phosphate (Ca-P) Coating Draft February 21, 1997 Do Do
Guidance for Preparation of FDA
Submissions for Orthopedic and Dental
Endosseous Implants
Draft Data Requirements for Ultrahigh March 28, 1995 Do Do
Molecular Weight Polyethylene
(Uhmupe) Used in Orthopedic Devices
Draft Guidance Document for Femoral August 1, 1995 Do Do
Stem Prostheses
Draft Guidance Document for Testing May 1, 1995 Do Do
Acetabular Cup Prostheses
Draft Guidance Document for the September 5, 1996 Do Do
Preparation of Premarket Notification
[510(k)] Applications for Orthopedic
Devices-The Basic Elements
Draft Guidance for the Preparation of April 1, 1993 Do Do
Premarket Notifications [510(k)]s for
Cemented, Semi-Constrained Total Knee
Prostheses
Draft Guideline for Reviewing Spinal January 9, 1997 Do Do
Fixation Device Systems
Draft of Guidance Document for Testing October 25, 1995 Do Do
of Orthopedic Implants with Metallic
Plasma Sprayed Porous Coatings
Subject to Required Post Market
Surveillance
Draft Outline for a Guidance Document November 1, 1993 Do Do
for Testing Orthopedic Bone Cement,
request for comments by December 10,
1993
Guidance Document for Testing April 20, 1996 Do Do
Biodegradable Polymer Implant Devices
Guidance Document for Testing Bone April 20, 1996 Do Do
Anchor Devices Draft
[[Page 9814]]
Guidance Document for Testing Non- May 1, 1995 Do Do
Articulating ``Mechanically Locked''
Modular Implant Components
Guidance Document for Testing April 28, 1994 Do Do
Orthopedic Implants with Modified
Metallic Surfaces Apposing Bone Or
Bone Cement
Guidance Document For The Preparation January 10, 1995 Do Do
of Premarket Notification For Ceramic
Ball Hip Systems
510(k) Sterility Review Guidance July 3, 1997 Do Do
Reviewers Guidance Checklist for February 21, 1997 Do Do
Intramedullary Rods
Reviewers Guidance Checklist for February 21, 1997 Do Do
Orthopedic External Fixation Devices
Draft 510(k) Guideline for General May 10, 1995 Do Do
Surgical Electrosurgical Devices
Draft Guidance for Arthroscopes and May 1, 1994 Do Do
Accessory 510(k)s
Draft Premarket Notification Review June 1, 1994 Do Do
Guidance for Evoked Response
Somatosensory Stimulators
Draft Version 1--Biofeedback Devices-- August 1, 1994 Do Do
Draft Guidance for 510(k) Content
Draft Version Cranial Perforator July 13, 1994 Do Do
Guidance
Draft Version Neuro Endoscope Guidance July 7, 1994 Do Do
Guidance on the Content and June 1, 1995 Do Do
Organization of a Premarket
Notification for a Medical Laser
Guidelines for Reviewing Premarket Do Do
Notifications that Claim Substantial
Equivalence to Evoked Response
Stimulators
Review of ``YAG'' Lasers for Do Do
Neurosurgery
Draft Version--Guidance on September 12, 1994 Do Do
Biocomatibility Requirements for Long
Term Neurological Implants: Part 3--
Implant Model
Protocol for Dermal Toxicity for Do Do
Devices in Contact with Skin (Draft)
Addendum to Guidance on the Content March 9, 1994 ODE/Division of Do
and Format of Premarket Notification Dental Infection
[510(k)] Submissions for General Control and General
Purpose Disinfectants Hospital Devices
(DDIGD)
Guidance on Premarket Notification August 1, 1993 Do Do
[510(k)] Submissions for Automated
Endoscope Washers, Washer/
Disinfectors, and Disinfectors
Intended for Use in Health Care
Facilities
Guidance on Premarket Notification August 1, 1993 Do Do
[510(k)] Submissions for Surgical
Gowns and Surgical Drapes
Guidance on the Content and Format of December 6, 1996 Do Do
Premarket Notification 510(k)
Submissions for Liquid Chemical
Germicides
Guidance on the Content and Format of October 1, 1993 Do Do
Premarket Notification [510(k)]
Submissions for General Purpose
Disinfectants
Guidance on the Content and Format of October 1, 1993 Do Do
Premarket Notification [510(k)]
Submissions for Sharps Containers
Draft Supplementary Guidance on the March 1, 1995 Do Do
Content of Premarket Notification
[510(k)] Submissions for Medical
Devices with Sharps Injury Prevention
Features (Anti-stick)
Guidance on 510(k) Submissions for October 1, 1990 Do Do
Implanted Infusion Ports
Guidance on Premarket Notification March 16, 1995 Do Do
[510(K)] Submissions for Short-Term
and Long-Term Intravascular Catheters
Guidance on the Content of Premarket March 1, 1993 Do Do
Notification [510(K)] Submissions for
Clinical Electronic Thermometers
Guidance on the Content of Premarket March 1, 1993 Do Do
Notification [510(k)] Submissions for
External Infusion Pumps
Guidance on the Content of Premarket April 1, 1993 Do Do
Notification [510(K)] Submissions for
Hypodermic Single Lumen Needles
[[Page 9815]]
Guidance on the Content of Premarket April 1, 1993 Do Do
Notification [510(K)] Submissions for
Piston Syringes
510(k) Guidance for Screw Type August 11, 1992 Do Do
Endosseous Implants for Prosthetic
Attachment
510(k) Information Needed for July 6, 1993 Do Do
Hydroxyapatite Coated Titanium
Endosseous Implants
510(k) Information Needed for August 12, 1993 Do Do
Metallurgical Endosseous Implants
510(k) Information Needed for Ti- July 13, 1993 Do Do
Powder Coated Titanium Endosseous
Implants
Draft Guidance Document for the March 3, 1997 Do Do
Preparation of Premarket Notification
[510(k)'S] for Dental Alloys
Guidance Document for the Preparation January 23, 1995 Do Do
of Premarket Notifications (510(k)'s)
for Temporomandibular Joint Implants
Guidance For The Arrangement and May 16, 1989 Do Do
Content of a Premarket Approval (PMA)
Application For An Endosseous Implant
For Prosthetic Attachment
Guidance for the Preparation of Do Do
Premarket Notification [510(k)] for
Resorbable Periodontal Barriers
Information Necessary for Premarket December 9, 1996 Do Do
Notification Submissions For Screw-
Type Endosseous Implants
Outline of Recommended Procedures for Do Do
a Clinical Investigation of
Endosseous Implants Under a 510(k)
Outline of Recommended Procedures for Do Do
Animal Laboratory Studies of
Endosseous Implants
Recommendations of the Dental Products Do Do
Panel Subcommittee on Dental Lasers
Guidance Document on Dental Handpieces July 1, 1995 Do Do
Groups Capable of Testing for Latex July 28, 1997
Skin Sensitization (Addendum to #994)
Draft Percutaneous Transluminal February 7, 1995 ODE/Division of Do
Coronary Angioplasty Package Insert Cardiovascular,
Template Respiratory and
Neurological Devices
(DCRND)
Medical Device Labeling--Suggested April 25, 1997 Do Do
Format and Content; Draft Document
Guidance for Off-the-Shelf Software June 4, 1997 Do Do
Use in Medical Devices; Draft
Document
Carotid Stent--Suggestions for Content October 26, 1996 Do Do
of Submissions to the Food and Drug
Administration in Support of
Investigational Devices Exemption
(IDE) Applications
Non-Invasive Blood Pressure (NIBP) March 10, 1997 Do Do
Monitor Guidance
Draft Guidance for the Content of August 22, 1995 Do Do
Preliminary Investigational Device
Exemptions (Pre-IDE) Presentations:
Teleconferences, Meetings and Written
Submissions
Electrocardiograph (ECG) Electrode-- February 11, 1997 Do Do
Version 1.0 Electrocardiograph (ECG)
Lead Switching Adapter--Version 1.0
Electrocardiograph (ECG) Surface February 11, 1997 Do Do
Electrode Tester--Version 1.0
Guidance for the Preparation and December 4, 1987 Do Do
Content of Applications to the Food
and Drug Administration for
Ventricular Assist Devices and Total
Artificial Hearts (draft)
Guidance for the Submission of 510(k) Do Do
Premarket Notifications for
Cardiovascular Intravascular Filters
Preliminary Guidance for Ambulatory September 1, 1994 Do Do
Electrocardiograph for Data to be
Submitted to FDA in Support of
Premarket Notification Applications
Preliminary Guidance for Data to be December 1, 1994 Do Do
Submitted in Support of Premarket
Notifications for Analyzing ECGs/
Interpretive ECGs
[[Page 9816]]
Preliminary Guidance for Data to be April 25, 1994 Do Do
Submitted to the FDA in Support of
Premarket Notification Applications
for External Cardioverters and
Defibrillators
Reviewer Checklist for Monitors: EMC, January 24, 1996 Do Do
Battery and Software
510(k) Reviewer Guidelines-- Do Do
Tracheostomy Tubes 868.5800
Automated Defibrillators: Operator's August 8, 1991 Do Do
Shift Checklist and Manual
Defibrillators: Operator's Shift
Checklist
Balloon Valvuloplasty Guidance For The January 1, 1989 Do Do
Submission Of an IDE Application and
a PMA Application
Battery Guidance (Draft) (Albert July 12, 1993 Do Do
Moyal)
Catheter Guidance May 15, 1991 Do Do
Coronary and Cerebrovascular Guidewire January 1, 1995 Do Do
Guidance
DCRND--Draft Guidance for Format and July 19, 1995 Do Do
Content for Premarket Notification
510(k) [replaces 908]
[cardiovascular, respiratory,
neurological]
Determining Equivalence of Intraaortic January 24, 1989 Do Do
Balloon Catheters Under the 510(k)
Regulations
Draft 510(K) Submission Requirements January 13, 1994 Do Do
for Peak Flow Meters
Draft Emergency Resuscitator Guidance April 14, 1993 Do Do
Draft Guidance for Implantable June 19, 1996 Do Do
Cardioverter-Defibrillators
Draft Guidance for the Preparation of August 1, 1993 Do Do
Research and Marketing Applications
for Vascular Graft Prostheses
Draft Guidance for the Submission of May 1, 1995 Do Do
Research and Marketing Applications
for Interventional Cardiology
Devices: PTCA Catheters, Atherectomy
Catheters, Lasers, Intravascular
Draft Guidance: Human Heart Valve June 21, 1991 Do Do
Allografts
Draft Premarket Notification Review June 1, 1994 Do Do
Guidance for Evoked Response
Somatosensory Stimulators
Draft Replacement Heart Valve Guidance October 14, 1994 Do Do
Draft Reviewer Guidance for July 1, 1995 Do Do
Ventilators
Draft Reviewer Guidance on Face Masks March 16, 1996 Do Do
and Shield for CPR
Draft Version--Guidance on September 12, 1994 Do Do
Biocompatibility Requirements for
Long Term Neurological Implants: Part
3--Implant Model
Draft Version 1--Biofeedback Devices-- August 1, 1994 Do Do
Draft Guidance for 510(k) Content
Draft Version Cardiac Ablation March 1, 1995 Do Do
Preliminary Guidance (Data to be
Submitted to the FDA in Support
Investigation Device Exemption
Application
Draft Version Cranial Perforator July 13, 1994 Do Do
Guidance
Draft Version Electrode Recording March 1, 1995 Do Do
Catheter Preliminary Guidance (Data
to be Submitted to the FDA in Support
of Premarket Notifications
Draft Version Guidance for Clinical August 20, 1992 Do Do
Data to be Submitted for Premarket
Approval Application for Cranial
Electrotherapy Stimulators
Draft Version Guide for Cortical August 10, 1992 Do Do
Electrode 510(k) Content
Draft Version Neuro Endoscope Guidance July 7, 1994 Do Do
Excerpts Related to EMI from November November 1, 1993 Do Do
1993 Anesthesiology and Respiratory
Devices Branch (to be used with EMI
standard)
Galvanic Skin Response Measurement August 23, 1994 Do Do
Devices--Draft Guidance for 510(k)
Content
General Guidance Document: Non- September 7, 1992 Do Do
Invasive Pulse Oxymeter
Guidance for Oxygen Conserving Device February 1, 1989 Do Do
510(k) Review 73 BZD 868.5905 Non-
continuous Ventilator Class II
Guidance for Peak Flow Meters for Over- Do Do
the-Counter Sale
[[Page 9817]]
Guidance for Safety and Effectiveness March 1, 1983 Do Do
Data Required in Premarket
Notification (510(k)) Applications
for Blood Oxygenators
Guidance for Studies for Pain Therapy May 12, 1988 Do Do
Devices--General Considerations in
the Design of Clinical Studies for
Pain-Alleviating Devices
Guidance for the Preparation of the April 1, 1990 Do Do
Annual Report to the PMA Approved
Heart Valve Prostheses
Guide for 510(k) Review of Processed June 26, 1990 Do Do
Human Dura Mater
Guide for TENS 510(k) Content (Draft) August 1, 1994 Do Do
Guidelines for Reviewing Premarket Do Do
Notifications that Claim Substantial
Equivalence to Evoked Response
Stimulators
Heated Humidifier Review Guidance August 30, 1991 Do Do
Implantable Pacemaker Lead Testing September 1, 1989 Do Do
Guidance For The Submission of a
Section 510(k) Notification
Implantable Pacemaker Testing Guidance January 12, 1990 Do Do
Policy for Expiration Dating (DCRND October 30, 1992 Do Do
RB92-G)
Protocol for Dermal Toxicity Testing Do Do
for Devices in Contact with Skin
(Draft)
Review Guidelines for Oxygen Do Do
Generators and Oxygen Equipment
Review of ``YAG'' Lasers for Do Do
Neurosurgery
Reviewer Guidance for Nebulizers, November 9, 1990 Do Do
Metered Dose Inhalers, Spacers and
Actuators
Reviewer's Guidance for Oxygen August 30, 1991 Do Do
Concentrator
Draft Intravascular Brachytherapy-- May 24, 1996 Do Do
Guidance for Data to be Submitted to
the Food and Drug Administration in
Support of Investigational Device
Exemption (IDE) Applications
Assessing the Safety/Effectiv. of Home- October 1, 1988 ODE/Division of Do
use In Vitro Diagnostic Devices Clinical Laboratory
(IVDs): Draft Points to Consider Devices (DCLD)
Regarding Labeling and Premarket
Submissions
Review Proposal for Reagents and March 14, 1995 Do Do
Analyzer Systems
Data for Commercialization of Original June 10, 1996 Do Do
Equipment Manufacturer, Secondary and
Generic Reagents for Automated
Analyzers
DCLD Tier/Triage lists (include 931) May 31, 1996 Do Do
Draft Criteria for Assessment of In August 31, 1995 Do Do
Vitro Diagnostic Devices for Drugs of
Abuse Assays Using Various
Methodologies
Draft Document entitled Proposed April 28, 1992 Do Do
Format: Package Insert for
Immunohistochemistry Products (cover
memo dated 5/12/92)
Draft Guidance Document for 510(k) July 29, 1992 Do Do
Submission of Fecal Occult Blood
Tests
Draft Guidance Document for 510(k) September 30, 1991 Do Do
Submission of Glycohemoglobin
(Glycated or Glycosylated) Hemoglobin
for IVDs
Draft Guidance Document for 510(k) September 1, 1992 Do Do
Submission of Immunoglobulins A,G,M,D
and E Immunoglobulin System In Vitro
Devices
Draft Guidance for 510(k) Submission September 26, 1991 Do Do
of Lymphocyte Immunophenotyping IVDs
using Monoclonal Antibodies
Draft Guidance For Submission of April 17, 1995 Do Do
Immunohistochemistry Applications to
the FDA/cover letter
Draft Review Criteria for Nucleic Acid June 14, 1993 Do Do
Amplification Based In Vitro
Diagnostic Devices for Direct
Detection of Infectious
Microorganisms
Draft: Premarketing Approval Review September 10, 1992 Do Do
Criteria for Premarket Approval of
Estrogen (ER) or Progesterone (PGR)
Receptors In Vitro Diagnostic Devices
Using Steroid Hormone
Guidance Criteria for Cyclosporine January 24, 1992 Do Do
PMAs
[[Page 9818]]
Labeling Requirements for Drugs of January 27, 1987 Do Do
Abuse Screening Test Kits
Points to Consider & Questions and October 19, 1993 Do Do
Answers on Immunohistochemistry
Products (cover memo dated 10/18/
1993)
Points to Consider for Cervical July 25, 1994 Do Do
Cytology Devices
Points to Consider for Collection of September 26, 1994 Do Do
Data in Support of In-Vitro Device
Submissions for 510(k) Clearance
Points to Consider for Portable Blood February 20, 1996 Do Do
Glucose Monitoring Devices Intended
for Bedside Use in the Neonate
Nursery
Points to Consider for Review of February 1, 1996 Do Do
Calibration and Quality Control
Labeling for In Vitro Diagnostic
Devices/Cover Letter dated 3/14/1996
Review Criteria for In Vitro February 1, 1994 Do Do
Diagnostic Devices for the Assessment
of Thyroid Autoantibodies using
Indirect Immunofluorescence Assay
(IFA), Indirect
Review Criteria for Assessment of July 15, 1994 Do Do
Alpha-Fetoprotein (AFP) in vitro
Diagnostic Devices for Fetal Open
Neural Tube Defects Using
Immunological Test Methodologies
Review Criteria for Assessment of May 31, 1991 Do Do
Antimicrobial Susceptibility Devices
Review Criteria for Assessment of July 15, 1991 Do Do
Cytogenetic Analysis Using Automated
and Semi-Automated Chromosome
Analyzers
Review Criteria for Assessment of September 27, 1995 Do Do
Human Chorionic Gonadotropin (hCG) In
Vitro Diagnostic Devices (IVDs)
Review Criteria for Assessment of In January 1, 1992 Do Do
Vitro Diagnostic Devices for Direct
Detection of Chlamydiae in Clinical
Specimens
Review Criteria for Assessment of In July 6, 1993 Do Do
Vitro Diagnostic Devices for Direct
Detection of Mycobacterium Spp.
[Tuberculosis (TB)]
Review Criteria for Assessment of September 17, 1992 Do Do
Laboratory Tests for the Detection of
Antibodies to Helicobacter pylori
Review Criteria for Assessment of February 14, 1996 Do Do
Portable Blood Glucose In Vitro
Diagnostic Devices Using Glucose
Oxidase, Dehydrogenase, or Hexokinase
Methodology
Review Criteria for Blood Culture August 12, 1991 Do Do
Systems
Review Criteria for Devices Assisting May 31, 1990 Do Do
in the Diagnosis of C. Difficile
Associated Diseases
Review Criteria for Devices Intended December 30, 1991 Do Do
for the Detection of Hepatitis B
``e'' Antigen and Antibody to HBe
Review Criteria for In Vitro August 1, 1992 Do Do
Diagnostic Devices for Detection of
IGM Antibodies to Viral Agents
Review Criteria for In Vitro February 15, 1996 Do Do
Diagnostic Devices that Utilize
Cytogenetic In Situ Hybridization
Technology for the Detection of Human
Genetic Mutations (Germ Line and
Review Criteria For Premarket Approval May 15, 1992 Do Do
of In Vitro Diagnostic Devices for
Detection of Antibodies to Parvovirus
B19
Review Criteria for the Assessment of March 2, 1993 Do Do
Allergen-Specific Immunoglobulin E
(IGE) In-Vitro Diagnostic Devices
Using Immunological Test
Methodologies
Review Criteria for the Assessment of September 1, 1992 Do Do
Anti-nuclear Antibodies (ANA) In-
Vitro Diagnostic Devices Using
Indirect Immunofluorescence Assay
(IFA),
Guidance Document for the Submission September 19, 1996 Do Do
of Tumor Associated Antigen Premarket
Notification [510(k)] to FDA
[[Page 9819]]
Review Criteria for Assessment of February 21, 1997 Do Do
Rheumatoid Factor (RF) In Vitro
Diagnostic Devices Using Engzyme-
Linked Immunoassay (EIA), Enzyme
Linked Immunosorbent Assay (ELISA),
Particle
Guidance for 510(k)s on Cholesterol July 14, 1995 Do Do
Tests for Clinical Laboratory,
Physicians' Office Laboratory, and
Home Use
Clinical Utility and Premarket May 3, 1991 ODE Do
Approval #P91-1 (blue book memo)
Criteria for Panel Review of PMA January 30, 1986 Do Do
Supplements #P86-3 (blue book memo)
Panel Report and Recommendations on April 18, 1986 Do Do
PMA Approvals #P86-5 (blue book memo)
Panel Review of ``Me-Too'' Devices July 1, 1986 Do Do
#P86-6 (blue book memo)
Panel Review of Premarket Approval May 3, 1991 Do Do
Applications #P91-2 (blue book memo)
PMA Compliance Program #P91-3 (blue May 3, 1991 Do Do
book memo)
PMA Filing Decisions #P90-2 (blue book May 18, 1990 Do Do
memo)
PMA Refuse to File Procedures #P94-1 May 20, 1994 Do Do
(blue book memo)
PMA Supplements: ODEs letter to April 24, 1990 Do Do
manufacturers; identifies situations
which may require the submission of a
PMA supplement (When PMA Supplements
are Required) #P90-1 (blue book memo)
PMAs--Early Review and Preparation of January 27, 1986 Do Do
Summaries of Safety and Effectiveness
#P86-1 (blue book memo)
Premarket Approval Application (PMA) July 8, 1994 Do Do
Closure #P94-1 (blue book memo)
Review and Approval of PMAs of October 22, 1990 Do Do
Licensees #P86-4 (blue book memo)
Review of Final Draft Medical Device August 29, 1991 Do Do
Labeling #P91-4 (blue book memo)
Assignment of Review Documents #I90-2 August 24, 1990 Do Do
(blue book memo)
Document Review Processing #I91-1 February 12, 1992 Do Do
(blue book memo)
Integrity of Data and Information May 29, 1991 Do Do
Submitted to ODE #I91-2 (blue book
memo)
Meetings with the Regulated Industry November 20, 1989 Do Do
#I89-3 (blue book memo)
Nondisclosure of Financially Sensitive March 5, 1992 Do Do
Information #I92-1 (blue book memo)
Policy Development and Review February 15, 1990 Do Do
Procedures #I90-1 (blue book memo)
Telephone Communications Between ODE January 29, 1993 Do Do
Staff and Manufacturers #I93-1 (blue
book memo)
Delegation of IDE Actions #D88-1 (blue April 26, 1988 Do Do
book memo)
Goals and Initiatives for the IDE July 12, 1995 Do Do
Program #D95-1 (blue book memo)
IDE Refuse to Accept Procedures #D94-1 May 20, 1994 Do Do
(blue book memo)
Implementation of the FDA/HCFA September 15, 1995 Do Do
Interagency Agreement Regarding
Reimbursement Categorization of
Investigational Devices, Att. A
Interagency Agreement, Att. B
Criteria
Overdue IDE Annual Progress Report July 23, 1993 Do Do
Procedures #D93-1 (blue book memo)
Review of IDEs for Feasibility Studies May 17, 1989 Do Do
#D89-1 (blue book memo)
Consolidated Review of Submissions for October 19, 1990 Do Do
Diagnostic Ultrasound Equipment,
Accessories and Related Measurement
Devices #G90-2 (blue book memo)
Consolidated Review of Submissions for October 19, 1990 Do Do
Lasers and Accessories #G90-1 (blue
book memo)
Device Labeling Guidance #G91-1 (blue March 8, 1991 Do Do
book memo)
[[Page 9820]]
Documentation and Resolution of December 23, 1993 Do Do
Differences of Opinion on Product
Evaluations #G93-1 (blue book memo)
ODE Regulatory Information for the May 15, 1987 Do Do
Office of Compliance - Information
Sharing Procedures #G87-2 (blue book
memo)
PMA/510(k) Expedited Review #G94-2 May 20, 1994 Do Do
(blue book memo)
PMA/510(k) Triage Review Procedures May 20, 1994 Do Do
#G94-1 (blue book memo)
Review of Laser Submissions #G88-1 April 15, 1988 Do Do
(blue book memo)
Toxicology Risk Assessment Committee August 9, 1989 Do Do
#G89-1 (blue book memo)
Use of International Standard ISO- May 1, 1995 Do Do
10993, ``Biological Evaluation of
Medical Devices Part 1: Evaluation
and Testing'' (Replaces #G87-1 #8294)
(blue book memo)
510(k) Additional Information July 23, 1993 Do Do
Procedures #K93-1 (blue book memo)
510(k) Refuse to Accept Procedures May 20, 1994 Do Do
#K94-1 (blue book memo)
510(k) Sign-Off Procedures #K94-2 June 3, 1994 Do Do
(blue book memo)
510(k) Sterility Review Guidance - and February 12, 1990 Do Do
Revision of 11/18/1994 #K90-1 (blue
book memo)
Cover Letter: 510(k) Requirements November 21, 1995 Do Do
During Firm-Initiated Recalls;
Attachment A: Guidance on Recall and
Premarket Notification Review
Procedures During Firm-Initiated
Recalls of Legally Marketed Drugs
(blue book #K95-1)
Guidance on the Center for Devices and June 30, 1986 Do Do
Radiological Health's Premarket
Notification Review Program #K86-3
(blue book memo)
Premarket Notification - Consistency February 28, 1989 Do Do
of Reviews #K89-1 (blue book memo)
Review of 510(k)s for Computer August 29, 1991 Do Do
Controlled Medical Devices #K91-1
(blue book memo)
Continued Access to Investigational July 15, 1996 Do Do
Devices During PMA Preparation and
Review (blue book memo)
Use of IEC 60601 Standards Medical October 10, 1997 Do Do
Electrical Equipment; Draft Document
[blue book memo #G97-X]
(blue book memo #K97-1) Deciding When January 10, 1997 Do Do
to Submit a 510(k) for a Change to an
Existing Device [see CDRH F-O-D #935]
Memorandum of Understanding Regarding August 9, 1996 Do Do
Patient Labeling Review (blue book
memo #G96-3))
#D95-2, Attachment A (Interagency September 15, 1995 Do Do
Agreement between FDA & HCFA)
#D95-2, Attachment B (Criteria for September 15, 1995 Do Do
Categorization of Investigational
Devices (HCFA)
510(k) Quality Review Program (blue March 29, 1996 Do Do
book memo)
Distribution and Public Availability October 10, 1997 Do Do
of PMA Summary of Safety and
Effectiveness Data Packages
Document Review by the Office of the June 6, 1996 Do Do
Chief Counsel (blue book memo G96-1))
Draft Guidance for Testing MR May 22, 1996 Do Do
Interaction with Aneurysm Clips
HCFA Reimbursement Categorization September 15, 1995 Do Do
Determinations for FDA-approved IDEs
ODE Executive Secretary Guidance August 7, 1987 Do Do
Manual
Tripartie Biocompatibility Guidance April 24, 1984 Do Do
Guidance for Submitting Do Do
Reclassification Petition
Product Development Protocol October 1, 1997 Do Do
Exemption from Reporting and Record September 16, 1981 Do Do
keeping Requirements for Certain
Sunlamp Product Manufacturers
[[Page 9821]]
Reporting of New Model Numbers to June 14, 1983 Do Do
Existing Model Families
----------------------------------------------------------------------------------------------------------------
IV. Guidance Documents Issued by the Center for Drug Evaluation and
Research (CDER)
----------------------------------------------------------------------------------------------------------------
How to Obtain a Hard Copy of
Grouped by Intended the Document (Name and
Name of Document Date of Issuance User or Regulatory Address, Phone, FAX, E-mail,
Activity or Internet)
----------------------------------------------------------------------------------------------------------------
Consumer-Directed Broadcast August 12, 1997 Advertising (Draft) Office of Training and
Advertisements Communications, Drug
Information Branch, Food and
Drug Administration, 5600
Fishers Lane, Rockville, MD
20857, 301-827-4573 or
Internet at http://
www.fda.gov/cder/guidance/
index.htm
Promoting Med Products (Multicenter) January 5, 1998 Do Do
Aerosol Steroid Product Safety January 12, 1998 Do Do
Information in Prescript. Drug
Advertising and Promotional Labeling
DDMAC 2
Dissemination of Reprints of Certain October 8, 1996 Advertising Do
Published, Original Data
Funded Dissemination of Reference October 8, 1996 Do Do
Texts
Antifungal (topical) February 24, 1990 Biopharmaceutic Drug Information Branch
(Draft)
Antifungal (vaginal) February 24, 1990 Do Do
Food-Effect Bioavailability and December 30, 1997 Do Do
Bioequivalence
In Vivo Bioequivalence Studies Based December 30, 1997 Do Do
on Population and Individual
Bioequivalence Approaches
Pharmacokinetics and Pharmacodynamics June 16, 1997 Do Drug Information Branch or
in Patients with Impaired Renal Internet at http://
Function: Study Design, Data www.fda.gov/cder/guidance/
Analysis, and Impact on Dosing and index.htm
Labeling
Population Pharmacokinetics September 18, 1997 Do Do
Waiver Policy March 29, 1993 Do Drug Information Branch
Acetohexamide (tablets) In Vivo August 1, 1988 Biopharmaceutic Do
Bioequivalence and In Vitro
Dissolution Testing
Albuterol Inhalation Aerosols (Metered January 27, 1994 Do Do
Dose Inhalers) In Vivo Bioequivalence
and In Vitro Dissolution Testing
Albuterol Sulfate (tablets) In Vivo May 29, 1987 Do Do
Bioequivalence and In Vitro
Dissolution Testing
Allopurinol (tablets) In Vivo July 15, 1985 Do Do
Bioequivalence and In Vitro
Dissolution Testing
Alprazolam Tablets In Vivo November 27, 1992 Do Do
Bioequivalence and In Vitro
Dissolution Testing
Amiloride Hydrochloride (tablets) In March 29, 1985 Do Do
Vivo Bioequivalence and In Vitro
Dissolution Testing
Aminophylline (suppositories) In Vivo July 5, 1983 Do Do
Bioequivalence and In Vitro
Dissolution Testing
Amitriptyline Hydrochloride (tablets) July 5, 1983 Do Do
In Vivo Bioequivalence and In Vitro
Dissolution Testing
Amoxapine (tablets) In Vivo August 5, 1988 Do Do
Bioequivalence and In Vitro
Dissolution Testing
Amoxicillin (capsules, tablets and June 10, 1988 Do Do
suspension) In Vivo Bioequivalence
and In Vitro Dissolution Testing
Approaches to Statistical Data November 1, 1985 Do Do
Analysis of Bioavailability/
Bioequivalence Studies
Atenolol (tablets) In Vivo October 6, 1988 Do Drug Information Branch or
Bioequivalence and In Vitro Internet at http://
Dissolution Testing www.fda.gov/cder/guidance/
index.htm
Baclofen (tablets) In Vivo May 5, 1986 Do Drug Information Branch
Bioequivalence and In Vitro
Dissolution Testing
Bioavailability Policies and Do Do
Guidelines
[[Page 9822]]
Bumetanide Tablets In Vivo April 23, 1993 Do Drug Information Branch or
Bioequivalence and In Vitro Interent at http://
Dissolution Testing www.fda.gov/cder/guidance/
index.htm
Buspirone Hydrochloride Tablets In August 13, 1993 Do Do
Vivo Bioequivalence and In Vitro
Dissolution Testing
Captopril Tablets In Vivo May 13, 1993 Do Do
Bioequivalence and In Vitro
Dissolution Testing
Carbamazepine (tablets) In Vivo January 20, 1988 Do Drug Information Branch
Bioequivalence and In Vitro
Dissolution Testing
Carbidopa and Levodopa Tablets In Vivo June 19, 1992 Do Drug Information Branch or
Bioequivalence and In Vitro Internet at http://
Dissolution Testing www.fda.gov/cder/guidance/
index.htm
Cefaclor Capsules and Suspension In April 23, 1993 Do Do
Vivo Bioequivalence and In Vitro
Dissolution Testing
Cefadroxil (capsules, tablets and October 7, 1986 Do Drug Information Branch
suspension) In Vivo Bioequivalence
and In Vitro Dissolution Testing
Cephalexin (tablets and capsules) In March 19, 1987 Do Do
Vivo Bioequivalence and In Vitro
Dissolution Testing
Cephradine (Capsule and Suspension) September 10, 1986 Do Do
Chlordiazepoxide (Tablets) July 5, 1983 Do Do
Chlordiazepoxide Hydrochloride July 5, 1983 Do Do
(Capsules)
Chlorpropamide (Tablets) July 5, 1983 Do Do
Chlorthalidone (Tablets) July 5, 1983 Do Do
Cholestyramine Powder In Vitro July 15, 1993 Do Drug Information Branch or
Bioequivalence Internet at http://
www.fda.gov/cder/guidance/
index.htm
Cimetidine Tablets In Vivo June 12, 1992 Do Do
Bioequivalence and In Vitro
Dissolution Testing
Clindamycin Hydrochloride (capsules) May 31, 1988 Do Drug Information Branch
In Vivo Bioequivalence and In Vitro
Dissolution Testing
Clofibrate (Capsules) April 7, 1986 Do Do
Clonidine Hydrochloride (Tablets) December 5, 1984 Do Do
Clorazepate Dipotassium (Capsules and February 17, 1987 Do Do
Tablets)
Clozapine (Tablets) In Vivo November 15, 1996 Do Drug Information Branch or
Bioequivalence and In Vitro Internet at http://
Dissolution Testing www.fda.gov/cder/guidance/
index.htm
Controlled Release Dosage Forms: September 10, 1985 Do Drug Information Branch
Issues and Controversies (Conference
Report)
Corticosteroids, Dermatologic June 2, 1995 Do Do
(topical) In Vivo
Cyclobenzaprine Hydrochloride January 25, 1988 Do Do
(tablets) In Vivo Bioequivalence and
In Vitro Dissolution Testing
Desipramine Hydrochloride (Tablets) September 22, 1987 Do Do
Diazepam (Tablets) July 8, 1985 Do Do
Diclofenac Sodium (tablets) In Vivo October 6, 1994 Do Do
Bioequivalence and In Vitro
Dissolution Testing
Dicyclomine Hydrochloride (Tablets and August 1, 1984 Do Do
Capsules)
Diflunisal Tablets In Vivo May 16, 1992 Do Drug Information Branch or
Bioequivalence and In Vitro Internet at http://
Dissolution Testing www.fda.gov/cder/guidance/
index.htm
Diltiazem Hydrochloride Tablets In May 16, 1992 Do Do
Vivo Bioequivalence and In Vitro
Dissolution Testing
Dipyridamole (Tablets) September 25, 1987 Do Drug Information Branch
Disopyramide Phosphate (Capsules) July 9, 1985 Do Do
Dissolution Testing (General) April 1, 1978 Do Do
Dissolution Testing of Immediate August 25, 1997 Do Drug Information Branch or
Release Solid Oral Dosage Forms Internet at http://
www.fda.gov/cder/guidance/
index.htm
Division Guidelines for the Evaluation April 18, 1984 Do Drug Information Branch
of Controlled Release Drug Products
Doxepin Hydrochloride (Capsules) October 9, 1986 Do Do
Doxycycline Hyclate (Capsules and April 11, 1988 Do Do
Tablets)
Erythromycin Capsules (Enteric Coated September 21, 1988 Do Do
Pellets)
Estropipate Tablets In Vivo August 26, 1992 Do Drug Information Branch or
Bioequivalence and In Vitro Internet at http://
Dissolution Testing www.fda.gov/cder/guidance/
index.htm
Extended Release Oral Dosage Forms: September 26, 1997 Do Do
Development, Evaluation, and
Application of In Vitro/In Vivo
Correlations (BP2)
[[Page 9823]]
Fenoprofen (capsules and tablets) In February 3, 1988 Do Drug Information Branch
Vivo Bioequivalence and In Vitro
Dissolution Testing
Flurazepam Hydrochloride (capsules) In October 15, 1985 Do Do
Vivo Bioequivalence and In Vitro
Dissolution Testing
Flurbiprofen (tablets) In Vivo June 8, 1995 Do Do
Bioequivalence and In Vitro
Dissolution Testing
Format and Content of the Human February 1, 1987 Do Do
Pharmacokinetics and Bioavailability
Section of an Application*\1\
Gemfibrozil Capsules or Tablets In June 15, 1992 Do Drug Information Branch or
Vivo Bioequivalence and In Vitro Internet at http://
Dissolution Testing www.fda.gov/cder/guidance/
index.htm
Glipizide (Tablets) In Vivo April 23, 1993 Do Do
Bioequivalence and In Vitro
Dissolution Testing
Glyburide Tablets In Vivo April 23, 1993 Do Do
Bioequivalence and In Vitro
Dissolution Testing
Guanabenz Acetate Tablets In Vivo April 23, 1993 Do Do
Bioequivalence and In Vitro
Dissolution Testing
Haloperidol (tablets) In Vivo April 30, 1987 Do Drug Information Branch
Bioequivalence and In Vitro
Dissolution Testing
Hydrochlorothiazide (tablets) In Vivo September 28, 1987 Do Do
Bioequivalence and In Vitro
Dissolution Testing
Hydroxychloroquine Sulfate (tablets) December 28, 1995 Do Do
In Vivo Bioequivalence and In Vitro
Dissolution Testing
Hydroxyzine Hydrochloride (tablets) March 4, 1986 Do Do
(dissolution only)
Hydroxyzine Pamoate (capsules) In Vivo September 28, 1987 Do Do
Bioequivalence and In Vitro
Dissolution Testing
Indapamide (tablets) In Vivo April 23, 1993 Do Do
Bioequivalence and In Vitro
Dissolution Testing
Indomethacin (capsules) In Vivo January 27, 1988 Do Do
Bioequivalence and In Vitro
Dissolution Testing
Isopropamide Iodide (tablets) In Vivo May 12, 1982 Do Do
Bioequivalence and In Vitro
Dissolution Testing
Isosorbide Dinitrate (chewable September 22, 1987 Do Do
tablets, oral tablets, and sublingual
tablets) In Vivo Bioequivalence and
In Vitro Dissolution Testing
Isosorbide Dinitrate Controlled November 6, 1985 Do Do
Release Products
Ketoprofen (capsules) In Vivo April 23, 1993 Do Do
Bioequivalence and In Vitro
Dissolution Testing
Leucovorin Calcium (tablets) In Vivo August 4, 1988 Do Do
Bioequivalence and In Vitro
Dissolution Testing
Lorazepam (tablets) In Vivo September 16, 1987 Do Do
Bioequivalence and In Vitro
Dissolution Testing
Loxapine Succinate (capsules) In Vivo September 10, 1987 Do Do
Bioequivalence and In Vitro
Dissolution Testing
Maprotiline Hydrochloride (tablets) In August 27, 1987 Do Do
Vivo Bioequivalence and In Vitro
Dissolution Testing
Meclofenamate Sodium (capsules) In November 12, 1986 Do Do
Vivo Bioequivalence and In Vitro
Dissolution Testing
Medroxyprogesterone Acetate (tablets) September 17, 1987 Do Do
In Vivo Bioequivalence and In Vitro
Dissolution Testing
Megestrol Acetate (tablets) In Vivo August 17, 1987 Do Do
Bioequivalence and In Vitro
Dissolution Testing
Metaproterenol Sulfate (tablets) In March 18, 1988 Do Do
Vivo Bioequivalence and In Vitro
Dissolution Testing
Metaproterenol Sulfate and Albuterol June 27, 1989 Do Do
Metered Dose Inhalers In Vitro
Metaproterenol Sulfate and Albuterol June 27, 1989 Do Do
Metered Dose Inhalers In Vitro
Methylprednisolone (tablets) In Vivo June 12, 1986 Do Do
Bioequivalence and In Vitro
Dissolution Testing
Metoclopramide Hydrochloride (tablets) December 27, 1984 Do Do
In Vivo Bioequivalence and In Vitro
Dissolution Testing
Metoprolol Tartrate (tablets) In Vivo June 12, 1992 Do Do
Bioequivalence and In Vitro
Dissolution Testing
Minoxidil (Tablets) June 12, 1986 Do Do
Nadolol (tablets) In Vivo May 16, 1992 Do Do
Bioequivalence and In Vitro
Dissolution Testing
Nafcillin Sodium (Capsules and September 10, 1987 Do Do
Tablets)
Nalidixic Acid (Tablets) August 19, 1997 Do Do
[[Page 9824]]
Naproxen (tablets) In Vivo June 8, 1995 Do Do
Bioequivalence and In Vitro
Dissolution Testing
Nitrofurantion Macrocrystalline January 10, 1986 Do Do
(capsules) In Vivo Bioequivalence and
In Vitro Dissolution Testing
Nitroglycerin (Ointment) December 17, 1986 Do Do
Norethindrone and Ethinyl Estradiol March 18, 1988 Do Do
(tablets) In Vivo Bioequivalence and
In Vitro Dissolution Testing
Norethindrone and Mestranol (tablets) May 13, 1988 Do Do
In Vivo Bioequivalence and In Vitro
Dissolution Testing
Nortriptyline Hydrochloride (capsules) June 12, 1992 Do Do
In Vivo Bioequivalence and In Vitro
Dissolution Testing
Oral Extended (controlled) Release In September 9, 1993 Do Drug Information Branch or
Vivo Bioequivalence and In Vitro Internet at http://
Dissolution Testing www.fda.gov/cder/guidance/
index.htm
Orphenadrine Citrate (tablets) In Vivo July 22, 1983 Do Drug Information Branch
Bioequivalence and In Vitro
Dissolution Testing
Pentoxifylline (extended-release December 22, 1995 Do Do
tablets) In Vivo Bioequivalence and
In Vitro Dissolution Testing
Perphenazine (tablets) In Vivo August 27, 1987 Do Do
Bioequivalence and In Vitro
Dissolution Testing
Perphenazine/Amitriptyline (tablets) August 27, 1987 Do Do
In Vivo Bioequivalence and In Vitro
Dissolution Testing
Pharmacokinetic Considerations in Drug N/A Do Do
Studies
Phenylbutazone Oxyphenbutazone September 28, 1987 Do Do
(capsules and tablets) In Vivo
Bioequivalence and In Vitro
Dissolution Testing
Phenytoin/Phenytion Sodium (capsules, March 4, 1994 Do Do
tablets, suspension) In Vivo
Bioequivalence and In Vitro
Dissolution Testing
Pindolol (tablets) In Vivo April 23, 1993 Do Do
Bioequivalence and In Vitro
Dissolution Testing
Piroxicam (capsules) In Vivo June 15, 1992 Do Do
Bioequivalence and In Vitro
Dissolution Testing
Potassium Chloride (slow-release May 15, 1987 Do Do
tablets and capsules) In Vivo
Bioequivalence and In Vitro
Dissolution Testing
Prazepam (capsules and tablets) In July 26, 1988 Do Do
Vivo Bioequivalence and In Vitro
Dissolution Testing
Prednisone (tablets) (dissolution July 10, 1985 Do Do
only)
Probenecid (Tablets) July 26, 1983 Do Do
Procainamide Hydrochloride September 28, 1987 Do Do
Propoxyphene Napsylate with March 26, 1980 Do Do
Acetaminphen (Tablets)
Propranolol Hydrochloride (tablets) In August 1, 1984 Do Do
Vivo Bioequivalence and In Vitro
Dissolution Testing
Propylthiouracil (tablets) In Vivo August 13, 1986 Do Do
Bioequivalence and In Vitro
Dissolution Testing
Quinidine Gluconate (tablets, September 22, 1987 Do Do
controlled release) In Vivo
Bioequivalence and In Vitro
Dissolution Testing
Ranitidine Hydrochloride (tablets) In April 23, 1993 Do Do
Vivo Bioequivalence and In Vitro
Dissolution Testing
Rifampin (capsules) In Vivo September 8, 1988 Do Do
Bioequivalence and In Vitro
Dissolution Testing
Ritodrine Hydrochloride (tablets) In August 27, 1987 Do Do
Vivo Bioequivalence and In Vitro
Dissolution Testing
Selegiline Hydrochloride (tablets) In December 22, 1995 Do Do
Vivo Bioequivalence and In Vitro
Dissolution Testing
Silver Sulfadiazine (cream) May 7, 1987 Do Do
Spironolactone (Tablets) January 1, 1986 Do Do
Statistical Procedure for July 1, 1992 Do Do
Bioequivalence Studies Using a
Standard Two-Treatment Crossover
Design
Submission of Data for Bioequivalence N/A Do Do
Studies in Computer Format
Sulfasalazine (tablets) In Vivo October 8, 1987 Do Do
Bioequivalence and In Vitro
Dissolution Testing
Sulfinpyrazone (Capsules and Tablets) September 25, 1987 Do Do
Sulfones (tablets) In Vivo November 7, 1986 Do Do
Bioequivalence and In Vitro
Dissolution Testing
[[Page 9825]]
Sulindac (tablets) In Vivo July 18, 1988 Do Do
Bioequivalence and In Vitro
Dissolution Testing
Temazepam (Capsules) August 8, 1985 Do Do
Theophylline (conventional dosage September 1, 1984 Do Do
form) In Vivo Bioequivalence and In
Vitro Dissolution Testing
Timolol Maleate (tablets) In Vivo August 9, 1988 Do Do
Bioequivalence and In Vitro
Dissolution Testing
Tolazamide (tablets) In Vivo May 30, 1986 Do Do
Bioequivalence and In Vitro
Dissolution Testing
Tolbutamide (tablets) In Vivo December 1, 1983 Do Do
Bioequivalence and In Vitro
Dissolution Testing
Tolmetin Sodium (tablets and capsules) October 6, 1994 Do Do
In Vivo Bioequivalence and In Vitro
Dissolution Testing
Trazodone Hydrochloride (tablets) In April 30, 1988 Do Do
Vivo Bioequivalence and In Vitro
Dissolution Testing
Triazolam (tablets) In Vivo December 24, 1992 Do Do
Bioequivalence and In Vitro
Dissolution Testing
Trimipramine Maleate (capsules) In August 18, 1987 Do Do
Vivo Bioequivalence and In Vitro
Dissolution Testing
Verapamil Hydrochloride (tablets) In July 18, 1985 Do Do
Vivo Bioequivalence and In Vitro
Dissolution Testing
Submission of Documentation in Drug July 15, 1997 Chemistry (Draft) Drug Information Branch or
Applications for Container Closure Internet at http://
Systems Used for the Packaging of www.fda.gov/cder/guidance/
Human Drugs and Biologics index.htm
Submitting Supporting Chemistry November 1, 1991 Do Drug Information Branch
Documentation in Radiopharmaceutical
Drug Applications*
Tracking of NDA and ANDA N/A Do Do
Reformulations for Solid, Oral,
Immediate Release Drug Products
(Docket No. 89N-0066)
Drug Master Files September 1, 1989 Chemistry Drug Information Branch or
Internet at http://
www.fda.gov/cder/guidance/
index.htm
FDA's Policy Statement for the May 1, 1992 Do Do
Development of New Stereoisomeric
Drugs
Format and Content for the CMC Section September 1, 1994 Do Do
of an Annual Report (CMC 1)
Format and Content of the Chemistry, February 1, 1987 Do Drug Information Branch
Manufacturing and Controls Section of
an Application*
Format and Content of the Microbiology February 1, 1987 Do Do
Section of an Application* (Docket
No. 85D-0245)
Reviewer Guidance: Validation of November 1, 1994 Do Drug Information Branch or
Chromatographic Methods (CMC 3) Internet at http://
www.fda.gov/cder/guidance/
index.htm
Submission of an Environmental November 13, 1995 Do Drug Information Branch or
Assessment in Human Drug Applications Internet at http://
and Supplements (CMC 6) www.fda.gov/cder/guidance/
index.htm
Submission of Chemistry, Manufacturing November 1, 1994 Do Drug Information Branch or
and Controls Information for Internet at http://
Synthetic Peptide Substances (CMC 4) www.fda.gov/cder/guidance/
index.htm
Submission of Documentation for November 1, 1994 Do Drug Information Branch or
Sterilization Process Validation Internet at http://
Applications for Human and Veterinary www.fda.gov/cder/guidance/
Drug Products (CMC 2) index.htm
Submitting Documentation for Packaging February 1, 1987 Do Do
for Human Drugs and Biologics*
Submitting Documentation for the February 1, 1987 Do Drug Information Branch
Manufacturing of and Controls for
Drug Products*
Submitting Documentation for the February 1, 1987 Do Do
Stability of Human Drugs and
Biologics*
Submitting Samples and Analytical Data February 1, 1987 Do Drug Information Branch or
for Methods Validation* Internet at http://
www.fda.gov/cder/guidance/
index.htm
Submitting Supporting Documentation in February 1, 1987 Do Do
Drug Applications for the Manufacture
of Drug Substances*
SUPAC IR-Immediate-Release Solid Oral November 30, 1995 Do Drug Information Branch or or
Dosage Forms: Scale-Up and Post- Internet at http://
Approval Changes: Chemistry, www.fda.gov/cder/guidance/
Manufacturing and Controls, In Vitro index.htm
Dissolution Testing, and In Vivo
Bioequivalence Documentation (CMC 5)
[[Page 9826]]
SUPAC-IR: Immediate Release Solid Oral October 21, 1997 Do Drug Information Branch or
Dosage Forms; Manufacturing Equipment Internet at http://
Addendum (CMC 9) www.fda.gov/cder/guidance/
index.htm
SUPAC-IR Questions and Answers February 18, 1997 Do Do
SUPAC-MR: Modified Release Solid Oral October 6, 1997 Do Drug Information Branch or
Dosage Forms: Scale-Up and Internet at http://
Postapproval Changes: Chemistry, www.fda.gov/cder/guidance/
Manufacturing, and Controls, In Vitro index.htm
Dissolution Testing, and In Vivo
Bioequivalence Documentation (CMC 8)
SUPAC-SS--Nonsterile Semisolid Dosage June 13, 1997 Do Drug Information Branch or
Forms; Scale-Up and Postapproval Internet at http://
Changes: Chemistry, Manufacturing, www.fda.gov/cder/guidance/
and Controls; In Vitro Release index.htm
Testing and In Vivo Bioequivalence
Documentation (CMC 7)
Abuse Liability Assessment July 1, 1990 Clinical (Draft) Drug Information Branch
Clinical Development Programs for January 10, 1997 Do Drug Information Branch or
Drugs, Devices, and Biological Internet at http://
Products for the Treatment of www.fda.gov/cder/guidance/
Rheumatoid Arthritis (RA) index.htm
Clinical Evaluation of Agents Used in April 1, 1994 Do Drug Information Branch
the Prevention or Treatment of
Postmenopausal Osteoporosis
Clinical Evaluation of Anti-Anginal January 1, 1989 Do Do
Drugs
Clinical Evaluation of Anti-Arrhythmic July 1, 1985 Do Do
Drugs
Clinical Evaluation of May 1, 1988 Do Do
Antihypertensive Drugs
Clinical Evaluation of Drugs for the December 1, 1987 Do Do
Treatment of Congestive Heart Failure
Clinical Evaluation of Drugs for the N/A Do Do
Treatment of Peripheral Vascular
Disease
Clinical Evaluation of Drugs for N/A Do Do
Ulcerative Colitis (3rd draft)
Clinical Evaluation of Motility- N/A Do Do
Modifying Drugs
Clinical Evaluation of Weight-Control July 12, 1995 Do Do
Drugs
Conducting a Clinical Safety Review of November 22, 1996 Do Do
a New Product Application and
Preparing a Report on the Review (96N-
0443)
Development and Evaluation of Drugs February 12, 1992 Do Do
for the Treatment of Psychoactive
Substance Use Disorders
Evaluating Clinical Studies of February 18, 1997 Do Drug Information Branch or
Antimicrobials in the Division of Internet at http://
Anti-Infective Drug Products www.fda.gov/cder/guidance/
index.htm
FDA Approval of New Cancer Treatment March 13, 1997 Do Do
Uses for Marketed Drug and Biological
Products
Points to Consider for System N/A Do Drug Information Branch
Inflammatory Response Syndrome (SIRS)
1st Draft
Points to Consider in the Preparation September 1, 1991 Do Do
of IND Applications for New Drugs
Intended for the Treatment of HIV-
Infected Individuals
Providing Clinical Evidence of March 13, 1997 Do Drug Information Branch or
Effectiveness for Human Drug and Internet at http://
Biological Products www.fda.gov/cder/guidance/
index.htm
Clinical Evaluation of Analgesic Drugs December 1, 1992 Clinical Drug Information Branch
(FDA 93-3093)
Clinical Evaluation of Antacid Drugs April 1, 1978 Do Drug Information Branch
(FDA 78-3065)
Clinical Evaluation of Anti-Infective November 1, 1992 Do Drug Information Branch
Drugs (Systemic) (FDA 77-3046)
Clinical Evaluation of Anti- May 26, 1993 Do Drug Information Branch
Inflammatory and Antirheumatic Drugs
(adults and children)
Clinical Evaluation of Antianxiety N/A Do Drug Information Branch
Drugs (FDA 77-3043)
Clinical Evaluation of Antidepressant September 1, 1977 Do Drug Information Branch
Drugs (FDA 77-3042)
Clinical Evaluation of Antidiarrheal September 1, 1977 Do Drug Information Branch
Drugs (FDA 78-3049)
Clinical Evaluation of Antiepileptic January 1, 1981 Do Drug Information Branch
Drugs (adults and children) (FDA 81-
3110)
Clinical Evaluation of Bronchodilator N/A Do Drug Information Branch
Drugs (FDA 79-3073)
Clinical Evaluation of Combination March 20, 1995 Do Drug Information Branch
Estrogen/Progestin-Containing Drug
Products Used for Hormone Replacement
Therapy of Postmenopausal Women
[[Page 9827]]
Clinical Evaluation of Drugs to November 1, 1978 Do Drug Information Branch
Prevent, Control and/or Treat
Periodontal Disease (FDA 79-3074)
Clinical Evaluation of Gastric September 1, 1977 Do Drug Information Branch
Secretory Depressant (GSD) Drugs (FDA
78-3050)
Clinical Evaluation of General May 1, 1982 Do Drug Information Branch
Anesthetics (FDA 78-3052)
Clinical Evaluation of Hypnotic Drugs September 1, 1977 Do Drug Information Branch
(FDA 78-3051)
Clinical Evaluation of Laxative Drugs April 1, 1978 Do Drug Information Branch
(FDA 78-3067)
Clinical Evaluation of Lipid-Altering N/A Do Drug Information Branch
Agents in Adults and Children (FDA 80-
3103)
Clinical Evaluation of Local May 1, 1982 Do Drug Information Branch
Anesthetics (FDA 82-3053)
Clinical Evaluation of Psychoactive July 1, 1979 Do Drug Information Branch
Drugs in Infants and Children (FDA 79-
3055)
Clinical Evaluation of October 1, 1981 Do Drug Information Branch
Radiopharmaceutical Drugs (FDA 81-
3120)
Content and Format for Pediatric Use May 24, 1996 Do Drug Information Branch or
Supplements (CLIN 1) Internet at http://
www.fda.gov/cder/guidance/
index.htm
Content and Format of Investigational November 20, 1995 Do Drug Information Branch or
New Drug Applications (INDs) for Internet at http://
Phase 1 Studies of Drugs, Including www.fda.gov/cder/guidance/
Well-Characterized, Therapeutic, index.htm
Biotechnology-Derived Products (CLIN
2)
Development of Vaginal Contraceptive April 19, 1995 Do Drug Information Branch
Drugs (NDA) (95D-0004)
Drug Metabolism/Drug Interaction April 7, 1997 Do Drug Information Branch or
Studies in the Drug Development Internet at http://
Process: Studies In Vitro (CLIN 3) www.fda.gov/cder/guidance/
index.htm
FDA Requirements for Approval of Drugs January 29, 1991 Do Drug Information Branch
to Treat Non-Small Cell Lung Cancer
FDA Requirements for Approval of Drugs June 20, 1989 Do Do
to Treat Superficial Bladder Cancer
Format and Content of the Clinical and July 1, 1988 Do Drug Information Branch or
Statistical Sections of New Drug Internet a http://
Applications* www.fda.gov/cder/guidance/
index.htm
Format and Content of the Summary for February 1, 1987 Do Drug Information Branch
New Drug and Antibiotic Applications*
Formatting, Assembling and Submitting February 1, 1987 Do Do
New Drug and Antibiotic Applications*
General Considerations for the December 1, 1978 Do Drug Information Branch
Clinical Evaluation of Drugs (FDA 77-
3040)
General Considerations for the N/A Do Drug Information Branch
Clinical Evaluation of Drugs in
Infants and Children (FDA 77-3041)
Oncologic Drugs Advisory Committee April 13, 1988 Do Drug Information Branch
Discussion on FDA Requirements for
Approval of New Drugs for Treatment
of Ovarian Cancer
Oncologic Drugs Advisory Committee N/A Do Do
Discussion on FDA Requirements for
Approval of New Drugs for Treatment
of Colon and Rectal Cancer
OTC Treatment of Hypercholesterolemia October 27, 1997 Do Drug Information Branch or
(CLIN 5) Internet at http://
www.fda.gov/cder/guidance/
index.htm
Points to Consider in the Clinical October 26, 1992 Do Drug Information Branch
Development and Labeling of Anti-
Infective Drug Products
Points to Consider in the Preclinical November 1, 1990 Do Do
Development of Antiviral Drugs
Points to Consider in the Preclinical May 1, 1993 Do Do
Development of Immunomodulatory Drugs
for the Treatment of HIV Infection
and Associated Disorders
Points to Consider: Clinical September 19, 1994 Do Do
Development Programs for MDI and DPI
Drug Products
Postmarketing Adverse Experience August 27, 1997 Do Drug Information Branch or
Reporting for Human Drugs and Internet at http://
Licensed Biological Products; www.fda.gov/cder/guidance/
Clarification of What to Report (CLIN index.htm
4)
Postmarketing Reporting of Adverse March 1, 1992 Do Drug Information Branch
Drug Experiences (85D-0249)
Preparation of Investigational New March 1, 1991 Do Drug Information Branch
Drug Products (Human and Animal)
[[Page 9828]]
Study and Evaluation of Gender July 22, 1993 Do Do
Differences in the Clinical
Evaluation of Drugs
Study of Drugs Likely to be Used in November 1, 1989 Do Do
the Elderly
Computerized Systems Used in Clinical June 18, 1997 Compliance (Draft) Drug Information Branch or
Trials Internet at http://
www.fda.gov/cder/guidance/
index.htm
Manufacture, Processing or Holding of September 20, 1996 Do Do
Active Pharmaceutical Ingredients
Repackaging of Solid Oral Dosage Form February 1, 1992 Do Drug Information Branch
Drug Products (92D-0345)
Supplements to New Applications, December 12, 1994 Do Drug Information Branch
Abbreviated New Drug Applications or
Abbreviated Antibiotic Applications
for Nonsterile Drug Products (93D-
0403)
A Review of FDA's Implementation of N/A Compliance Drug Information Branch
the Drug Export Amendments of 1986
Compressed Medical Gases December 1, 1989 Do Do
Current Good Manufacturing Practices April 22, 1997 Do Drug Information Branch or
for Positron Emission Tomographic Internet at http://
(PET) Drug Products (CP 1) www.fda.gov/cder/guidance/
index.htm
Expiration Dating and Stability June 27, 1997 Do Drug Information Branch or
Testing of Solid Oral Dosage Form Internet at http://
Drugs Containing Iron (CP 2) www.fda.gov/cder/guidance/
index.htm
General Principles of Process May 1, 1987 Do Drug Information Branch or
Validation Internet at http://
www.fda.gov/cder/guidance/
index.htm
Good Laboratory Practice Regulations N/A Do Drug Information Branch
Questions and Answers
Monitoring of Clinical Investigations January 1, 1988 Do Do
Nuclear Pharmacy Guideline Criteria May 1, 1984 Do Do
for Determining When to Register as a
Drug Establishment
Sterile Drug Products Produced by May 1, 1987 Do Do
Aseptic Processing
Validation of Limulus Amebocyte Lysate December 1, 1987 Do Do
Test as an End-Product Endotoxin Test
for Human and Animal Parenteral
Drugs, Biological Products, and
Medical Devices
Content and Format of an Abbreviated April 18, 1997 Generic Drug (Draft) Drug Information Branch or
New Drug Application (ANDA)--Positron Internet at http://
Emission Tomography (PET) Drug www.fda.gov/cder/guidance/
Products_With Specific Information index.htm
for ANDAs for Fludeoxyglucose F18
Injection
Letter announcing that the OGD will August 18, 1995 Generic Drug Drug Information Branch
now accept the ICH long-term storage
conditions as well as the stability
studies conducted in the past.
Letter describing efforts by the CDER October 14, 1994 Do Do
and the ORA to clarify the
responsibilities of CDER chemistry
review scientists and ORA field
investigators in the new and
abbreviated drug approval process in
order to reduce duplication or
redundancy
Letter on incomplete Abbreviated April 8, 1994 Do Do
Applications, Convictions Under GDEA,
Multiple Supplements, Annual Reports
for Bulk Antibiotics, Batch Size for
Transdermal Drugs, Bioequivalence
Protocols, Research, Deviations from
OGD Policy
Letter on the provision of new July 1, 1992 Do Do
information pertaining to new
bioequivalence guidelines and refuse-
to-file letters
Letter on the provision of new March 15, 1989 Do Do
procedures and policies affecting the
generic drug review process
Letter on the request for cooperation November 8, 1991 Do Do
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 submissions
Letter on the response to 12/20/84 March 26, 1985 Do Do
letter from the Pharmaceutical
Manufacturers Association about the
Drug Price Competition and Patent
Term Restoration Act
[[Page 9829]]
Letter to all ANDA and AADA applicants January 15, 1993 Do Do
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 law
Letter to regulated industry notifying August 4, 1993 Do Do
interested parties about important
detailed information regarding
labeling, scale-up, packaging, minor/
major amendment criteria, and
bioequivalence requirements
Organization of an Abbreviated New April 7, 1997 Do Drug Information Branch or
Drug Application and an Abbreviated Internet at http://
Antibiotic Application (OGD 1) www.fda.gov/cder/guidance/
index.htm
Positron Emission Tomography Questions October 24, 1996 Do Drug Information Branch or
and Answers 1 Internet at http://
www.fda.gov/cder/guidance/
index.htm
Positron Emission Tomography Questions April 18, 1997 Do Do
and Answers 2
A Revision in Sample Collection Under July 15, 1996 Industry letters Drug Information Branch
the Compliance Program Pertaining to
Pre-Approval Inspections
Certification Requirements for July 27, 1992 Do Do
Debarred Individuals in Drug
Applications
Continuation of a series of letters June 1, 1990 Do Do
communicating interim and informal
generic drug policy and guidance.
Availability of Policy and Procedure
Guides, and further operational
changes to the generic drug review
program
Fifth of a series of letters providing April 10, 1987 Do Do
informal notice about the Act,
discussing the statutory mechanism by
which ANDA applicants may make
modifications in approved drugs where
clinical data is required
Fourth of a series of letters October 31, 1986 Do Do
providing informal notice to all
affected parties about policy
developments and interpretations
regarding the Act. Three year
exclusivity provisions of Title I
Implementation of the Drug Price October 11, 1984 Do Do
Competition and Patent Term
Restoration Act. Preliminary Guidance
Implementation Plan USP injection October 2, 1995 Do Do
nomenclature
In Vivo Bioequivalence Studies of April 22, 1996 Do Do
Clozapine
Instructions for Filing Supplements April 11, 1996 Do Do
Under the Provisions of SUPAC-IR
Seventh of a series of letters about July 29, 1988 Do Do
the Act providing guidance on the
``180-day exclusivity'' provision of
section 505(j)(4)(B)(iv) of the FD&C
Sixth of a series of informal notice April 28, 1988 Do Do
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 Act
Streamlining Initiatives December 24, 1996 Do Do
Supplement to 10/11/84 letter about November 16, 1984 Do Do
policies, procedures and
implementation of the Act (Q & A
format)
Third of a series of letters regarding May 1, 1985 Do Do
the implementation of the Act
Archiving Submissions in Electronic September 23, 1997 Information Drug Information Branch or
Format--NDAs (IT 1) Technology Internet at http://
www.fda.gov/cder/guidance/
index.htm
CANDA (Computer Assisted New Drug October 1, 1994 Do Drug Information Branch
Application) Guidance Manual (92D-
0296)
Acetaminophen and Codeine Phosphate December 1, 1993 Labeling Drug Information Branch
Oral Solution/Suspension
Acetaminophen and Codeine Phosphate December 1, 1993 Do Do
Tablets/Capsules
Acetaminophen, Aspirin and Codeine December 1, 1993 Do Drug Information Branch or
Phosphate Tablets/Capsules Internet at http://
www.fda.gov/cder/guidance/
index.htm
Alprazolam Tablets May 1, 1993 Do Do
[[Page 9830]]
Amiloride Hydrochloride and October 1, 1992 Do Do
Hydrochlorothiazide Tablets USP
Amlodipine Besylate Tablets (OGD-L-1) September 1, 1997 Do Do
Antihistamine Guidance April 1, 1983 Do Drug Information Branch
Astemizole Tablets (OGD-L-16) September 1, 1997 Do Do
Atenolol Tablets June 1, 1995 Do Drug Information Branch or
Internet at http://
www.fda.gov/cder/guidance/
index.htm
Barbiturate, Single Entity-Class March 1, 1981 Do Drug Information Branch
Labeling
Butalbital, Acetaminophen and Caffeine April 1, 1993 Do Drug Information Branch or
Capsules/Tablets Internet at http://
www.fda.gov/cder/guidance/
index.htm
Butalbital, Acetaminophen, Caffeine September 21, 1997 Do Drug Information Branch
and Hydocodone Bitartrate Tablets
(OGD-L-6-R1)
Butorphanol Tartrate Injection USP October 1, 1992 Do Drug Information Branch or
Internet at http://
www.fda.gov/cder/guidance/
index.htm
Captopril and Hydrochlorothiazide April 1, 1995 Do Do
Tablets
Captopril Tablets February 1, 1995 Do Drug Information Branch
Carbidopa and Levodopa Tablets February 1, 1992 Do Drug Information Branch or
Internet at http://
www.fda.gov/cder/guidance/
index.htm
Chlordiazepoxide Hydrochloride January 1, 1988 Do Drug Information Branch
Capsules
Cimetidine Hydrochloride Injection September 1, 1995 Do Drug Information Branch or
Internet at http://
www.fda.gov/cder/guidance/
index.htm
Cimetidine Tablets September 1, 1995 Do Do
Cisapride Oral Suspension (OGD-L-3) September 1, 1997 Do Do
Cisapride Tablets (OGD-L-4) September 1, 1997 Do Do
Clindamycin Phosphate Injection USP May 1, 1992 Do Do
Clorazepate Dipotassium Capsules/ March 1, 1993 Do Drug Information Branch
Tablets
Combination Oral Contraceptives-- January 1, 1994 Do Do
Physician and Patient Labeling
Cyproheptadine Hydrochloride Tablets/ December 1, 1986 Do Do
Syrup
Diclofenac Sodium Delayed-Release February 1, 1995 Do Drug Information Branch or
Tablets Internet at http://
www.fda.gov/cder/guidance/
index.htm
Diltiazem Hydrochloride Extended- September 1, 1995 Do Do
Release Capsules (twice a day dosage)
Diphenoxylate Hydrochloride and April 1, 1995 Do Do
Atropine Sulfate Oral Solution
Diphenoxylate Hydrochloride and April 1, 1995 Do Do
Atropine Sulfate Tablets
Dipivefrin Hydrochloride Ophthalmic May 1, 1992 Do Drug Information Branch
Solution, 0.1%
Ergoloid Mesylates Tablets January 1, 1988 Do Do
Estrogen Class Labeling Guidance August 1, 1992 Do Do
Fludeoxyglucose F18 Injection January 1, 1997 Do Drug Information Branch or
Internet at http://
www.fda.gov/cder/guidance/
index.htm
Flurbiprofen Tablets USP January 1, 1994 Do Do
Fluroxamine Maleate Tablets (OGD-L-15) September 1, 1997 Do Do
Gentamicin Sulfate Ophthalmic Ointment April 1, 1992 Do Do
and Solution
Heparin Sodium Injection USP March 1, 1991 Do Do
Hydrocodone Bitartrate and April 1, 1994 Do Do
Acetaminophen Tablets
Hydroxyzine Hydrochloride Injection December 1, 1989 Do Drug Information Branch
Hydroxyzine Hydrochloride Tablets/ May 1, 1986 Do Do
Syrup
Hypoglycemic Oral Agents--Federal April 1, 1984 Do Do
Register
Indomethacin Capsules USP September 1, 1995 Do Drug Information Branch or
Internet at http://
www.fda.gov/cder/guidance/
index.htm
Informal Labeling Guidance Texts for December 1, 1992 Do Drug Information Branch
Estrogen Drug Products--Patient
Labeling
Informal Labeling Guidance Texts for December 1, 1992 Do Do
Estrogen Drug Products--Professional
Labeling
Isoetharine Inhalation Solution March 1, 1989 Do Do
Leucovorin Calcium for Injection N/A Do Drug Information Branch or
Internet at http://
www.fda.gov/cder/guidance/
index.htm
Leucovorin Calcium Tablets, USP July 1, 1996 Do Drug Information Branch
[[Page 9831]]
Local Anesthetics--Class Labeling September 1, 1982 Do Do
Meclofenamate Sodium Capsules July 1, 1992 Do Do
Medroxy-progesterone Acetate Tablets, November 1, 1997 Do Do
USP OGD-L-36
Metaproterenol Sulfate Inhalation May 1, 1992 Do Drug Information Branch or
Solution, 5% Internet at http://
www.fda.gov/cder/guidance/
index.htm
Metaproterenol Sulfate Syrup May 1, 1992 Do Do
Metaproterenol Sulfate Tablets May 1, 1992 Do Do
Metoclopramide Tablets USP/Oral February 1, 1995 Do Do
Solution
Naphazoline Hydrochloride Ophthalmic March 1, 1989 Do Drug Information Branch
Solution
Naproxen Sodium Tablets, USP OGD-L-10- September 1, 1997 Do Drug Information Branch or
R1 Internet at http://
www.fda.gov/cder/guidance/
index.htm
Naproxen Tablets, USP OGD-L-9-R1 September 1, 1997 Do Do
Niacin Tablets July 1, 1992 Do Drug Information Branch
Paclitaxel Injection OGD-L-8 September 1, 1997 Do Do
Phendimetrazine Tartrate Capsules/ February 1, 1991 Do Do
Tablets, and Extended-Release
Capsules
Phentermine Hydrochloride Capsules/ August 1, 1988 Do Do
Tablets
Promethazine Hydrochloride Tablets March 1, 1990 Do Do
Propantheline Bromide Tablets August 1, 1988 Do Do
Pyridoxine Hydrochloride Injection June 1, 1984 Do Do
Quinidine Sulfate Tablets/Capsules October 1, 1995 Do Do
Ranitidine Tablets November 1, 1993 Do Drug Information Branch or
Internet at http://
www.fda.gov/cder/guidance/
index.htm
Risperidone Oral Solution OGD-L-18 September 1, 1997 Do Do
Risperidone Tablets OGD-L-17 September 1, 1997 Do Do
Sulfacetamide Sodium and Prednisolone January 1, 1995 Do Do
Acetate Ophthalmic Suspension and
Solution
Sulfacetamide Sodium Ophthalmic August 1, 1992 Do Do
Solution/Ointment
Sulfamethoxazole and Phenazopyridine February 1, 1992 Do Drug Information Branch
Hydrochloride Tablets
Sulfamethoxazole and Trimethoprim August 1, 1993 Do Drug Information Branch or
Tablets and Oral Suspension Internet at http://
www.fda.gov/cder/guidance/
index.htm
Theophylline Immediate-Release Dosage February 1, 1995 Do Drug Information Branch
Forms
Theophylline Intravenous Dosage Forms February 9, 1996 Do Do
Thiamine Hydrochloride Injection February 1, 1988 Do Do
Tobramycin Sulfate Injection May 1, 1993 Do Drug Information Branch
Internet at http://
www.fda.gov/cder/guidance/
index.htm
Topical Corticosteroids Class Labeling N/A Do Drug Information Branch
Venlafaxine Hydrochloride Tablets OGD- October 1, 1997 Do Do
L-30
Verapamil Hydrochloride Tablets October 1, 1991 Do Drug Information Branch or
Internet at http://
www.fda.gov/cder/guidance/
index.htm
Vitamin A Capsules February 1, 1992 Do Drug Information Branch
Zolpidem Tartrate Tablets OGD-L-13 September 1, 1997 Do Do
Points to Consider for OTC Actual Use July 22, 1994 OTC (Draft) Do
Studies
Enforcement Policy on Marketing OTC N/A OTC Do
Combination Products (CPG 7132b.16)
General Guidelines for OTC Combination N/A Do Do
Products (78D-0322)
OTC Nicotine Sustitutes March 1, 1994 Do Drug Information Branch
Upgrading Category III Antiperspirants N/A Do Do
to Category I (43 FR 46728-46731)
Format and Content of the Nonclinical February 1, 1987 Pharmacology/ Do
Pharmacology/Toxicology Section of an Toxicology
Application*
Points to Consider in the Nonclinical N/A Do Drug Information Branch or
Pharmacology/Toxicology Development Internet at http://
of Topical Drugs Intended to Prevent www.fda.gov/cder/guidance/
the Transmission of Sexually index.htm
Transmitted Diseases (STD) and/or for
the Development of Drugs Intended to
Act as Vaginal Contraceptives
[[Page 9832]]
Reference Guide for the Nonclinical February 1, 1989 Do Drug Information Branch
Toxicity Studies of Antiviral Drugs (REMOVE)
Indicated for the Treatment of Non-
Life Threatening Disease: Evaluation
of Drug Toxicity Prior to Phase I
Clinical Studies
----------------------------------------------------------------------------------------------------------------
\1\ Star (*) indicates that the guidance is one of 13, formerly known as the ``NDA Guidelines,'' or ``Rainbow
Pack,'' that are available as a set from the Drug Information Branch.
V. Guidance Documents Issued by the Center for Food Safety and
Applied Nutrition (CFSAN)
----------------------------------------------------------------------------------------------------------------
How to Obtain a Hard Copy of
Grouped by Intended the Document (Name and
Name of Document Date of Issuance User or Regulatory Address, Phone, FAX, E-mail,
Activity or Internet)
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guides Manual, PB96- 1996 FDA Regulated National Technical
920500 Industries Information Service (NTIS),
5285 Port Royal Rd.,
Springfield, VA 22161
Compliance Programs Guidance Manual, 1995 Do NTIS
PB95-915499
FDA Recall Policy 1995 Do Industry Activities Staff
(HFS-565), Center for Food
Safety and Applied
Nutrition, Food and Drug
Administration, 200 C St.
SW., Washington, DC 20204
Inspection Operations Manual, PB-95- October 1994 Do NTIS
913399
Regulatory Procedures Manual, PB95- August 1995 Do NTIS
265534
Requirements of Laws and Regulations 1997 Do Superintendent of Documents,
Enforced by the U.S. Food and Drug Government Printing Office,
Administration ``Blue Book'' Washington, DC 20402
Action Levels for Poisonous or 1995 Food and Animal Feed Industry Activities Staff
Deleterious Substances in Human Food Industries
and Animal Feed, PB96-920500
Pesticides Analytical Manual, PB94- 1994 Food Industry NTIS
911899
FDA Advisory for Deoxynivanol (DON) in September 16, 1993 Food and Animal Feed Office of Plant and Dairy
Finished Wheat Products Intended for Industries Foods and Beverages, Food
Human Consumption and in Grain and and Drug Administration (HFS-
Grain By-Products for Animal Feed 306), 200 C St. SW.,
Washington, DC 20204, 202-
205-4681
FDA's Cosmetic Labeling Manual October 1991 Cosmetic Industry Office of Colors and
Cosmetics (HFS-105), Food
and Drug Administration, 200
C St. SW., Washington, DC
20204, 202-205-4493
Statement of Policy: Foods Derived May 29, 1992 (57 Developers of New Office of Premarket Approval,
from New Plant Varieties: Notice FR 22984) Plant Food Varieties Food and Drug Administration
(HFS-200), 200 C St. SW.,
Washington, DC 20204, 202-
418-3100
A Food Labeling Guide September 1994 Food Industry Superintendent of Documents,
Appendix I--Model Small Business Food August 7, 1993 Do Industry Activities Staff
Labeling Exemption Notice
Food Labeling: Questions and Answers August 1993 Do Industry Activities Staff
Food Labeling: Questions and Answers: August 1995 Do Superintendent of Documents
Volume II
Fair Packaging and Labeling Act June 1978 Do NTIS
Requirements and Interpretations, PB-
83-222117
Bacteriological Analytical Manual, 7th 1992 FDA Regulated AOAC International, 481 N.
Edition Industries Frederick Ave., Suite 500,
Gaithersburg, MD 20877-2417,
301-924-7077
FDA Food Importer's Guide for Low-Acid 1995 Food Industry Industry Activities Staff
Canned and Acidified Foods
Fabrication of Single Service 1995 States Milk Safety Branch (HFS-626),
Containers and Closures for Milk and Center for Food Safety and
Milk Products Applied Nutrition, 200 C St.
SW., Washington, DC 20204,
202-205-9175
Evaluation of Milk Laboratories 1995 Do Do
Methods of Making Sanitation Ratings 1995 Do Do
Of Milk Supplies
[[Page 9833]]
Dry Milk Ordinance 1995 Do Do
Procedures Governing the Cooperative 1995 Dairy Industry Do
State-Public Health Service/Food and
Drug Administration Program for
Certification of Interstate Milk
Shippers
Frozen Dessert Processing Guidelines 1989 Do Office of Plant and Dairy
Foods and Beverages (HFS-
302), Center for Food Safety
and Applied Nutrition, 200 C
St. SW., Washington, DC
20204, 202-205-9175
Pasteurized Milk Ordinance 1995 States Milk Safety Branch
FDA Nutrition Labeling Manual: A Guide 1993 Food Industry Office of Food Labeling, Food
for Developing and Using Databases and Drug Administration (HFS-
150), 200 C St. SW.,
Washington, DC 20204, 202-
205-4561
Guidelines for Determining Metric October 1, 1993 Do Do
Equivalents of Household Measures
List of Food Defect Action Levels 1995 Food and Animal Feed Industry Activities Staff
(DALS) Industries
Action Levels for Poisonous or 1995 Do Do
Deleterious Substances in Human Food
and Feed (Also Found in CPG's)
1997 FDA Food Code 1997 States NTIS
Seafood List 1993 Seafood Industry Superintendent of Documents
Manual of Operations National 1992 States Office of Seafood (HFS-407),
Shellfish Sanitation Shellfish Sanitation Branch,
200 C St. SW., Washington,
DC 20204, 202-418-3150
Fish and Fisheries Products Hazards 1996 Seafood Industry Office of Seafood, Food and
and Controls Guide Drug Administration (HFS-
400), 200 C St. SW.,
Washington, DC 20204, 202-
418-3150
Guidance for Submitting Requests under 1996 Food Packaging Office of Premarket Approval
21 CFR 170.39, Threshold of Industry
Regulation for Substances Used in
Food Articles
Guidelines for the Preparation of 1996 Food Ingredient or Do
Petition Submissions Packaging Industry
Guidelines for Approval of Color 1996 Color or Contact Lens Do
Additives in Contact Lenses Intended Industry
as Colors
FDA Recommendations for Submission of February 1993 Color Additives Do
Chemical and Technological Data on Industry
Color Additives for Food, Drugs or
Cosmetics Use
Points to Consider for the Use of December 1992 Food Packaging Do
Recycled Plastics in Food Packaging: Industry
Chemistry Considerations
Recommendations for Submission of May 1993 Do Do
Chemical and Technological Data for
Direct Food Additive and GRAS Food
Ingredient Petitions
Recommendations for Chemistry Data for June 1995 Do Do
Indirect Food Additive Petitions
Enzyme Preparations: Chemistry January 1993 Food Enzyme Industry Do
Recommendations for Food Additive and
GRAS Affirmation Petitions
Estimating Exposure to Direct Food September 1995 Food and Food Office of Premarket Approval
Additive and Chemical Contaminants in Ingredient Industry
the Diet
Toxicological Principles for the 1982 Petitioners for Food NTIS
Safety Assessment of Direct Food or Color Additives
Additives and Color Additives Used in
Food (also known as Redbook I), PR-83-
170696
Environmental Assessment Technical March 1987 Do Do
Handbook, PB87175345-AS, A-01
Preparing Environmental Assessments: August 1990 Do Office of Premarket Approval
General Suggestions
Step-by-Step Guidance for Preparing March 1987 Do Do
Environmental Assessments
Environmental Assessment of Food- February 1994 Do Do
packaging Materials with Enhanced
Degradation Characteristics
Color Additive Petitions Information 1996 Petitioners for Color Do
and Guidance Additives
Toxological Testing of Food Additives 1983 Petitioners for Food Do
or Color Additives
List of Products for Each Product October 8, 1992 Food Industry Office of Food Labeling
Category
[[Page 9834]]
Label Declaration of Allergenic June 10, 1996 Do Do
Substances in Foods; Notice to
Manufacturers
Guidance on Labeling of Foods that February 24, 1997 Do Do
Need Refrigeration by Consumers (62 FR 8248)
Interim Guidance on the Voluntary February 10, 1994 Do Do
Labeling of Milk and Milk Products (59 FR 6279)
that have not been treated with
Recombinant Bovine Somatropin
Guidelines Concerning Notification and 1985 Infant Formula Office of Special
Testing of Infant Formula Manufacturers Nutritionals (HFS-450), Food
and Drug Administration, 200
C St. SW., Washington, DC
20204
Clinical Testing of Infant Formulas 1985 Do Do
with Respect to Nutritional
Suitability for Term Infants
Guidelines for the Evaluation of the 1988 Do Do
Safety and Suitability of New Infant
Formulas for Feeding Infants with
Allergic Diseases
Guidelines for the Evaluation of the 1990 Do Do
Safety and Suitability of Infant
Formulas for Feeding Infants with
Allergic Diseases
Guidelines for the Clinical Evaluation 1987 Do Do
of New Products Used in the Dietary
Management of Infants, Children and
Pregnant Women with Metabolic
Disorders
Guidance Document for Arsenic (Trace January 1993 States Office of Seafood (HFS-400)
Elements in Seafood) or via Internet: FDA Home
Page at http://
vm.cfsan.fda.gov/list.html
Guidance Document for Cadmium (Trace January 1993 Do Office of Seafood (HFS-400)
Elements in Seafood) or via Internet: FDA Home
Page at http://
vm.cfsan.fda.gov
Guidance Document for Chromium (Trace January 1993 Do Do
Elements in Seafood)
Guidance Document for Lead (Trace August 1993 Do Do
Elements in Seafood)
Guidance Document for Nickel (Trace January 1993 Do Do
Elements in Seafood)
FDA's Policy for Foods Developed by 1995 Food Industry Office of Premarket Approval
Biotechnology or via Internet: FDA Home
Page at http://
vm.cfsan.fda.gov
Bovine Spongiform Encephalopathy (BSE) 1997 Do Office of Plant and Dairy
In Products for Human Use Foods and Beverages or via
Internet: FDA Home Page at
http://www.fda.gov/opacom/
morechoices/industry/
guidance/gelguide.htm
Shellfish Sanitation Model Ordinance 1995 States Shellfish Program
Implementation Branch,
Division of Cooperative
Programs, Office of Field
Programs (HFS-628), 200 C
St. SW., Washington, DC
20204, 202-205-8137
----------------------------------------------------------------------------------------------------------------
VI. Guidance Documents Issued by the Center for Veterinary Medicine
(CVM)
----------------------------------------------------------------------------------------------------------------
How to Obtain a Hard Copy of
Grouped by Intended the Document (Name and
Name of Document Date of Issuance User or Regulatory Address, Phone, FAX, E-mail,
Activity or Internet)
----------------------------------------------------------------------------------------------------------------
Citizen Petitions: Policy and June 7, 1994 Do Do
Procedures (Guide No. 1240.2030)
CVM's Implementation of the Agency's June 15, 1994 Do Do
Fraud, Untrue Statements of Material
Facts, Bribery & Illegal Gratuities
Policy (Guide No. 1240.2040)
Intra-Agency Relationship (Guide No. August 11, 1993 Do Do
1240.2100)
Procedures for Resolving Disagreements April 10, 1991 Do Do
within CVM (Guide No. 1240.2110)
Product Manager (Guide No. 1240.2120) August 11, 1993 Do Do
[[Page 9835]]
CVM P & P Manual Utilization and September 3, 1997 Do Do
Maintenance (Guide No. 1240.2140)
CVM Small Business (Guide No. April 10, 1991 Do Do
1240.2150)
CVM Public Affairs Program (Guide No. April 7, 1995 Do Do
1240.2152)
Evaluation of Proposed Legislation April 7, 1995 Do Do
(Guide No. 1240.2154)
Voluntary Compliance (Guide No. August 11, 1992 Do Do
1240.2202)
Approval of New Animal Drug August 11, 1992 Do Do
Applications and their Supplements
(Guide No. 1240.2210)
Classification of OTC and Rx Drugs January 15, 1985 Do Do
(Guide No. 1240.2220)
Processing General Correspondence by June 28, 1993 Do Do
Individual Offices in CVM (Guide No.
1240.2300)
Routing of Congressional April 9, 1997 Do Do
Correspondence (Guide No. 1240.2302)
Correspondence to Practicing June 28, 1993 Do Do
Veterinarians, Vet Med Associations,
and other Scientific Disciplines
(Guide No. 1240.2310)
Communication and Liaison with other May 7, 1991 Do Do
Centers and Agencies (Guide No.
1240.2320)
Intercommunication between CVM and June 28, 1993 Do Do
Office of Chief Counsel (Guide No.
1240.2322)
CVM Guidance on Media Inquiries (Guide July 1, 1997 Do Do
No. 1240.2325)
Consultative Reviews and Opinions May 7, 1991 Do Do
(Guide No. 1240.2330)
Freedom of Information Requests (Guide September 4, 1997 Do Do
No. 1240.2500)
Public Availability of Food Additive June 25, 1993 Do Do
Petitions (Guide No. 1240.2501)
Advisory Opinions and Informal October 23, 1985 Do Do
Requests for Information (Guide No.
1240.2510)
Confidentiality of Center Files (Guide June 25, 1993 Do Do
No. 1240.2520)
Industry Conferences (Guide No. June 11, 1990 Do Do
1240.2600)
Meetings with Representatives from September 8, 1994 Do Do
Foreign Governments (Guide No.
1240.2601)
Trade Media Visits to CVM (Guide No. September 8, 1994 Do Do
1240.2610)
New Animal Drugs for Investigational September 30, 1996 Do Do
Use (Guide No. 1240.3000)
Processing Original Investigational September 30, 1996 Do Do
New Animal Drug Applications (Guide
No. 1240.3010)
Processing Amendments to An September 30, 1996 Do Do
Investigational New Animal Drug
Application (Guide No. 1240.3020)
Non-Routine Invest. New Animal Drugs September 30, 1996 Do Do
(Guide No. 1240.3025)
Initial Processing of an NADA (Guide March 25, 1991 Do Do
No. 1240.3100)
Review of Animal Safety and August 1, 1989 Do Do
Effectiveness Data (Guide No.
1240.3101)
Use of Foreign Non-Clinical and September 6, 1989 Do Do
Clinical Data in an NADA (Guide No.
1240.3102)
Review of Vet. Med. Guidelines (Guide November 23, 1993 Do Do
No. 1240.3103)
Specialty Reviews of NADAs (Guide No. December 17, 1993 Do Do
1240.3110)
Preparation of NADA Decision Package November 23, 1993 Do Do
(Guide No. 1240.3120)
Routing of NADA Decision Package November 23, 1993 Do Do
(Guide No. 1240.3122)
CVM Appeals Procedure Guide (Guide No. November 23, 1993 Do Do
1240.3130)
Animal Drug Applications Expedited November 23, 1993 Do Do
Review Guideline (Guide No.
1240.3135)
Labeling Policy for Animal Drugs that October 13, 1994 Do Do
may be Human Carcinogens (Guide No.
1240.3140)
NADA Review of Dosage Form Oral October 13, 1994 Do Do
Electrolytes (Guide No. 1240.3150)
Food Additive Petition Review (Guide December 7, 1993 Do Do
No. 1240.3300)
[[Page 9836]]
Nutritional Ingredients in Animal March 23, 1993 Do Do
Drugs and Feeds (Guide No. 1240.3420)
New Animal Drug Determination (Guide July 24, 1989 Do Do
No. 1240.3500)
New Animal Drug Regulation (Guide No. September 4, 1991 Do Do
1240.3502)
Drug Experience Reporting Requirements November 23, 1993 Do Do
(Guide No. 1240.3510)
Additional Sources of Adverse Reaction November 23, 1993 Do Do
and Injury Reports (Guide No.
1240.3512)
Drug Experience Reporting by May 7, 1997 Do Do
Veterinarians (Guide No. 1240.3514)
Adverse Reactions as a Basis for November 23, 1993 Do Do
Regulatory Action (Guide No.
1240.3520)
Animal Health Hazard Evaluation March 28, 1986 Do Do
Committee (Guide No. 1240.3521)
Review and Evaluation of Drug November 23, 1993 Do Do
Experience Reports (Guide No.
1240.3522)
Criteria for Veterinary Medical Review November 23, 1993 Do Do
of Establishment Inspection Reports
(Guide No. 1240.3524)
Procedures for Processing Drug November 23, 1993 Do Do
Experience Reports (Guide No.
1240.3530)
Consumer Complaint Letters (Guide No. September 6, 1989 Do Do
1240.3532)
NADAs, Withdrawal of Approvals (Guide November 23, 1993 Do Do
No. 1240.3540)
Implementation of Causal Reviews November 23, 1993 Do Do
(Guide No. 1240.3542)
Surveillance at Professional and Trade November 23, 1993 Do Do
Meetings (Guide No. 1240.3550)
Registration of Producers of Drugs and September 9, 1997 Do Do
Listing Of Drugs in Commercial
Distribution (Guide No. 1240.3560)
Types of Enforcement Activities (Guide September 9, 1997 Do Do
No. 1240.3600)
Types of Regulatory Actions (Guide No. September 9, 1997 Do Do
1240.3601)
Regulating Animal Foods with Drug September 9, 1997 Do Do
Claims (Guide No. 1240.3605)
Request for CGMP Establishment September 9, 1997 Do Do
Inspections (Guide No. 1240.3620)
Good Manufacturing Practice Compliance September 9, 1997 Do Do
Status (Guide No. 1240.3622)
Tissue Residue Reporting (Guide No. September 9, 1997 Do Do
1240.3630)
Diversion of Unfit Food to Animal Use September 9, 1997 Do Do
(Guide No. 1240.3650)
Development of Compliance Policy September 9, 1997 Do Do
Guides Affecting Veterinary Products
(Guide No. 1240.3660)
Preparation of Compliance Programs and September 9, 1997 Do Do
Program Circulars (Guide No.
1240.3661)
Management of Formal Evidentiary September 9, 1997 Do Do
Hearings (Guide No. 1240.3670)
Center for Veterinary Medicine November 3, 1993 Do Do
Research Activities (Guide No.
1240.3700)
Initiation and Approval of Research November 3, 1993 Do Do
Projects (Guide No. 1240.3710)
Identification/Promotion of NADA September 10, 1997 Do Do
Product Approval (Guide No.
1240.4000)
Procedure for Center Recommended September 10, 1997 Do Do
Labeling Changes (Guide No.
1240.4005)
Antibacterials Labeled for Secondary September 10, 1997 Do Do
Infections (Guide No. 1240.4010)
Uniformity in Labeling (Guide No. September 10, 1997 Do Do
1240.4020)
General Policies for Animal Drug Label September 10, 1997 Do Do
Review (Guide No. 1240.4021)
Therapeutic Use Directions for September 10, 1997 Do Do
Medicated Feed and Drinking Water
(Guide No. 1240.4025)
Established Names (Guide No. September 10, 1997 Do Do
1240.4030)
Clinical Investigator Sanctions & the September 10, 1997 Do Do
Videotex Method of Obtaining
Information on Ineligible
Investigators (Guide No. 1240.4040)
Criteria for the Approval of January 5, 1987 Do Do
Euthanasia Products (Guide No.
1240.4112)
[[Page 9837]]
Sterility of Ophthalmic Products December 7, 1993 Do Do
(Guide No. 1240.4120)
Sterility and Pyrogen Requirements for November 27, 1989 Do Do
Injectable Drug Products (Guide No.
1240.4122)
Overformulation in Animal Drug January 2, 1992 Do Do
Products (Guide No. 1240.4130)
Continuous Use Production Drugs & April 16, 1990 Do Do
Short-Term Therapeutic Treatments in
Feeds (Guide No. 1240.4145)
Ownership Transfer or Corporate January 2, 1992 Do Do
Identity Change of an Application
(Guide No. 1240.4150)
Policy on Sterilization of New Animal September 10, 1997 Do Do
Drug Products and Containers by
Irradiation (Guide No. 1240.4160)
CVM Medically Necessary Veterinary June 30, 1994 Do Do
Drug Product Shortage Management
(Guide No. 1240.4170)
Drug Use in Aquaculture Enforcement October 29, 1997 Do Do
Priorities (Guide No. 1240.4200)
Extra-label Use of Approved Drugs in October 29, 1997 Do Do
Aquaculture (Guide No. 1240.4210)
Drug-Pesticide Issues (Guide No. October 29, 1997 Do Do
1240.4220)
Regulation of Fish Identification October 29, 1997 Do Do
Products (Guide No. 1240.4230)
Safe Levels of Unapproved Drugs in October 29, 1997 Do Do
Aquaculture (Guide No. 1240.4240)
Classification of Aquaculture Species/ October 29, 1997 Do Do
Population as Food or Non-Food (Guide
No. 1240.4260)
Use of Drugs in Outdoor Aquatic October 29, 1997 Do Do
Research Facilities (Guide No.
1240.4270)
Generic Animal Drug and Patent Term November 23, 1988 Animal drug industry Communications Staff (HFV-
Restoration Act (GADPTRA) Policy 12), FDA/CVM, 7500 Standish
Letter 1.--Describes patent and Pl., Rockville, MD 20855,
exclusivity information to be 301-594-1755, FAX 301-594-
submitted to FDA by holders of 1831
approved NADAs and NADA applicants
GADPTRA Policy Letter 2.--Describes June 7, 1989 Do Do
format and content for suitability
petitions, format and content for
ANADAs, manufacturing requirements
for ANADAs, and environmental review
of generic animal drugs
GADPTRA Policy Letter 3.-- July 2, 1989 Do Do
``Exclusivity for human food safety
data submitted in supplemental
application,'' ``Withdrawal period
for generic drugs,'' ``Substitution
of an active ingredient in a
combination drug or in a feed use
combination,'' ``Labeling
Requirements for Generic Drugs,''
``Can a generic animal drug sponsor
obtain exclusivity for an innovation
approved under a supplement to an
ANADA and can the pioneer drug
sponsor copy the generic innovation
without submitting additional data?''
GADPTRA Policy Letter 4.--``Actions November 2, 1989 Do Do
concerning ANADAs when a pioneer drug
has been withdrawn from sale,''
``Effect of GADPTRA on approval of
pre-62 drugs under the DESI
program,'' ``Generic feed use
combination drugs''
GADPTRA Policy Letter 5.-- April 12, 1990 Do Do
Bioequivalence Guideline
GADPTRA Policy Letter 6.--``Withdrawal October 17, 1990 Do Do
period for generic animal drug
products,'' ``Eligibiliity of a new
salt or ester for a pioneer animal
drug''
GADPTRA Policy Letter 7.--``Guidance March 20, 1991 Do Do
for analytical methods for ANADAs,''
``ANADAs, NADAs and supplemental
approvals for subtherapeutic
antibiotics,'' ``Hybrid
applications,'' ``Waivers of In Vivo
bioequivalence studies for topical
products''
GADPTRA Policy Letter 8.--Generic July 23,1991 Do Do
copying of certain drugs that were
subject to review under the Drug
Efficacy Study Implementation (DESI)
program
[[Page 9838]]
GADPTRA Policy Letter 9.--``Policy June 27, 1995 Do Do
Statement on Environmental Review of
Generic Animal Drugs'' (Revision of a
policy statement of the same title in
Generic Policy Letter #2
Guide for Reporting Drug Shipment(s) June 19, 1992 Do Do
for Clinical Trials in Non-Food
Animals
Guide for Reporting The Details of no date Do Do
Clinical Trials Using Investigational
New Animal Drug(s) in Food-Producing
Animals
Aquaculture Drug Use: Answers to June 1995 Do Do Internet via http://
Commonly Asked Questions www.cvm.fda.gov/ Guideline 3.--General Principles for July 1994 Do Do
Evaluating the Safety of Compounds
Used in Food-Producing Animals
Guideline 4.--Guidelines for Efficacy no date Do Do
Studies for Systemic Sustained
Release Sulfonamide Boluses for
Cattle
Guideline 5.--Stability Guidelines December 1990 Do Do
Guideline 6.--Guidelines for March 1976 Do Do
Submitting NADA's for Generic Drugs
Reviewed by NAS/NRC
Guideline 9.--Preclearance Guidelines October 1975 Do Communications Staff
for Production Drugs
Guideline 10.--Amendment of Section October 1975 Do Do Internet at http://
II(G)(1)(b)(4) of the Preclearance www.cvm.fda.gov/
Guidelines
Guideline 13.--Guidelines for January 1985 Do Do
Evaluation of Effectiveness of New
Animal Drugs for Use in Free-Choice
Feeds (revision of Medicated Block)
Guideline 14.--Guideline and Format no date Do Do
for Reporting the Details of Clinical
Trials Using An Investigational New
Animal Drug in FOOD Producing Animals
Guideline 15.--Guideline and Format February 1977 Do Do
for Reporting the Details of Clinical
Trials Using An Investigational New
Animal Drug in NON-FOOD Producing
Animals
Guideline 16.--FOI Summary Guideline May 1985 Do Do
Guideline 18.--Antibacterial Drugs in no date Do Do
Animal Feeds: Human Health Safety
Criteria
Guideline 19.--Antibacterial Drugs in no date Do Do
Animal Feeds: Animal Health Safety
Criteria
Guideline 20.--Antibacterial Drugs in no date Do Do
Animal Feeds: Antibacterial
Effectiveness Criteria
Guideline 22.--Guideline Labeling of no date Do Do
Arecoline Base Drugs Intended for
Animal Use
Guideline 23.--Medicated Free Choice July 1985 Do Do
Feeds--Manufacturing Control
Guideline 24.----Guidelines for Drug October 1983 Do Do
Combinations for Use in Animals
Guideline 25.--Guidelines for the January 1979 Do Do
Efficacy Evaluation of Equine
Anthelmintics
Guideline 26.--Guidelines for the April 1986 Do Do
Preparation of Data to Satisfy the
Requirements of Section 512 of the
Act Regarding Animal Safety,
Effectiveness, Human Food Safety and
Environmental Considerations for
Minor Use of New Animal Drugs
Guideline 29.--Guidelines for the September 1980 Do Do
Effectiveness Evaluation of Swine
Anthelmintics
Guideline 31.--Guidelines for the July 1981 Do Do
Evaluation of Bovine Anthelmintics
Guideline 33.--Target Animal Safety June 1989 Do Do
Guidelines for New Animal Drugs
Guideline 35.--Bioequivalence 1996 Do Do
Guideline--Final (1996)
Guideline 36.--Guidelines for Efficacy July 1985 Do Do
Evaluation of Canine/Feline
Anthelmintics
Guideline 37.--Guidelines for March 1984 Do Do
Evaluation of Effectiveness of New
Animal Drugs for Use in Poultry Feed
for Pigmentation
Guideline 38.--Guideline for August 1984 Do Do
Effectiveness Evaluation of Topical/
Otic Animal Drugs
[[Page 9839]]
Guideline 40.--Draft Guideline for the April 1992 Do Do
Evaluation of the Efficacy of
Anticoccidial Drugs and Anticoccidial
Drug Combinations in Poultry
Guideline 41.--Draft Guideline: June 1992 Do Do
Formatting, Assembling, and
Submitting New Animal Drug
Applications
Guideline 42.--Series of four 1994 Do Do
guidelines entitled ``Animal Drug
Manufacturing Guidelines, 1994''
Guideline 43.--Guidance on Generic October 1995 Do Do
Animal Drug Products Containing
Fermentation-Derived Drug Substances
Guideline 45.--Guideline for Uniform August 1993 Do Do
Labeling of Drugs for Dairy and Beef
Cattle
Guideline 48.--Guidance for Industry November 1994 Do Communications Staff
for the Submission of Documentation
for Sterilization Process Validation
in Applications for Human and
Veterinary Drug Products
Guideline 49.--Guidance Document for April 1996 Do Do
Target Animal Safety and Drug
Effectiveness Studies for Anti-
Microbial Bovine Mastitis Products
Guideline 50.--Draft Guideline for February 1993 Do Do
Target Animal and Human Food Safety,
Drug Efficacy, Environmental and
Manufacturing Studies for Teat
Antiseptic Products
Guideline 51.--Points to Consider 1993 Do Do
Guideline--Development of a
Pharmacokinetic Guideline Enabling
Flexible Labeling of Therapeutic
Antimicrobials
Guideline 52.--Guidance-- January 1996 Do Do
Microbiological Testing of
Antimicrobial Drug Residues in Food
Guideline 53.--Guideline for the May 1994 Do Do
Evaluation of the Utility of Food
Additives in Diets Fed to Aquatic
Animals
Guideline 54.--Draft Guideline for June 1994 Do Do
Utility Studies for Anti-Salmonella
Chemical Food Additives in Animal
Feeds
Guideline 55.--Supportive Data for Cat June 1994 Do Do
Food Labels Bearing ``Reduces Urinary
pH Claims: Guideline in Protocol
Development''
Guideline 56.--Protocol Development November 1994 Do Do
Guideline for Clinical Effectiveness
and Target Animal Safety Trials
Guideline 57.--Master Files--Guidance July 1995 Do Do
for Industry for the Preparation and
Submission of Veterinary Master Files
Guideline 58.--Guidance for Industry May 1997 Do Do
for Good Target Animal Study
Practices: Clinical Investigators and
Monitors
Guideline 59.--Guidance to Industry June 1997 Do Do
Submitting Notices of Claimed
Investigational Exemption in
Electronic Format to CVM Via E-mail
Guideline 60.--Guidance for Industry June 1997 Do Do
Animal Proteins Prohibited From
Animal Feed, Small Entity Compliance
Guide
Guideline 61.--Draft Guidance for September 1997 Do Do
Industry--FDA Approval of Animal
Drugs for Minor Uses and for Minor
Species
Guideline 62.--Draft Guidance for August 1997 Do Do
Industry--Consumer-Directed Broadcast
Advertisements
NADA Pre-approval Inspections (No. November 1, 1993 FDA investigators and Freedom of Information Staff
7368.001) analysts and (HFI-35), Food and Drug
regulated industry Administration, 5600 Fishers
Lane, Rockville, MD 20857,
301-443-6310, FAX 301-443-
1726
Drug Process and New Animal Drug October 8, 1996 Do Do
Inspections (No. 7371.001)
Illegal Sales of Veterinary August 17, 1993 Do Do
Prescription Drugs (No. 7371.002)
Feed Contaminants (No. 7371.003) November 1, 1993 Do Do
(July 31, 1996--
Partial Revision)
Medicated Feeds (No. 7371.004) July 7, 1995 Do Do
[[Page 9840]]
Type A Medicated Articles (No. January 1, 1992 Do Do
7371.005)
Illegal Drug Residues in Meat and September 9, 1996 Do Do
Poultry (No. 7371.006)
Imported Bulk New Animal Drugs (No. October 1, 1991 Do Do
7371.007)
Center for Veterinary Medicine Public May 3, 1996 Do Do
Affairs Specialist Program (No.
7371.826)
CVM Initiates Veterinary Drug Listing February 3, 1994 Public information Communications Staff, FDA/
Verification CVM, 7500 Standish Pl. (HFV-
12), Rockville, MD 20855,
301-594-1755, FAX 301-594-
1831
FDA Position on the Extra-Label Use of September 14, 1995 Do Do
Fluoroquinolones
CVM Announces Opinion on Dipyrone December 6, 1995 Do Do
Products
Regulation of Animal Electronic January 17, 1996 Do Do
Identification Products
Update on Extra-Label Use of July 16, 1996 Do Do Internet via http://
Fluoroquinolones www.cvm.fda.gov/ Caution Urged in Using Warbex October 4, 1996 Do Do
Revised Labeling for Some Medicated January 30, 1997 Do Do
Feed Products
Colloidal Silver Not Approved For February 12, 1997 Do Do
Treating Animals
CVM Policy on Competitive Exclusion February 21, 1997 Do Do
Products
Updated Policy on the Use of Animal March 14, 1997 Do Do
Electronic Identification Products in
Swine
Human Drug Product not Equivalent to July 16, 1997 Do Do
Veterinary Ceftiofur
FDA Requests That Ball Clay Not be October 14, 1997 Do Do
Used in Animal Feeds
----------------------------------------------------------------------------------------------------------------
VII. Guidance Documents Issued by the Office of Policy
----------------------------------------------------------------------------------------------------------------
How to Obtain a Hard Copy of
Grouped by Intended the Document (Name and
Name of Document Date of Issuance User or Regulatory Address, Phone, FAX, E-mail,
Activity or Internet)
----------------------------------------------------------------------------------------------------------------
FDA's Development, Issuance and Use of February 1997 Internal FDA and Internet via www.fda.gov/
Guidance Documents regulated industry opacom/morechoices/
moreindu.html or Office of
Policy 301-827-3360
Industry Supported Scientific and December 1997 Regulated industry Internet via www.fda.gov/cder/
Educational Activities guidance/index.htm or Office
of Policy 301-827-3360
Draft Guidance on Consumer Directed February 1997 Do Do
Broadcast Advertisements
Direct Final Rule Guidance November 1997 Internal FDA Internet via www.fda.gov/
opacom/morechoices/industry/
preguide.htm or Marquita
Steadman 301-443-3480
Small Entities Compliance Guide On: February 1997 Regulated industry Internet via www.fda.gov/
Regulations to Restrict the Sale and opacom/campaigns/tobacco/
Distribution of Cigarettes and tobret.htm or 1-888-FDA-
Smokeless Tobacco in Order to Protect 4KIDS
Children and Adolescents (21 CFR Part
897)
Children and Tobacco--Frequently Asked July 1997 Do Internet via www.fda.gov/
Questions About the New Regulations- opacom/campaigns/tobacco/
Draft Guidance tobret.htm or 1-888-FDA-
4KIDS
Children & Tobacco--A Retailer's Guide October 1997 Do Internet via www.fda.gov/
to the New Federal Regulations opacom/campaigns/tobacco/
tobret.htm or 1-888-FDA-
4KIDS
Children & Tobacco--A Guide to the New October 1997 Do Internet via www.fda.gov/
Federal Regulations opacom/campaigns/tobacco/
tobret.htm or 1-888-FDA-
4KIDS
FDA's Standards Policy October 1995 Internal FDA and 60 FR 53078, October 11, 1995
regulated industry or Office of Policy 301-827-
3360
----------------------------------------------------------------------------------------------------------------
[[Page 9841]]
VIII. Guidance Documents Issued by the Office of Regulatory Affairs
----------------------------------------------------------------------------------------------------------------
How to Obtain a Hard Copy of
Grouped by Intended the Document (Name and
Name of Document Date of Issuance User or Regulatory Address, Phone, FAX, E-mail,
Activity or Internet)
----------------------------------------------------------------------------------------------------------------
Compliance Policy Guides Manual (PB96- August 1996 FDA Staff Personnel National Technical
915499) Information Service (NTIS),
5285 Port Royal Rd.,
Springfield, VA 22161 or via
Internet at www.fda.gov/ora/
compliance_ref/cpg/
cpgtc.html
FDA/ORA International Inspection May 1997 Do FDA, Division of Emergency
Manual and Travel Guide and Investigational
Operations (HFC-130), 5600
Fishers Lane, Rockville, MD
20857 or via Internet at
www.fda.gov/ora/inspect_ref/
itob/itob.html
Glossary of Computerized System and August 1995 Do NTIS or via Internet at
Software Development Terminology www.fda.gov/ora/inspect_ref/
(PB96-127352) igs/iglist.html
Import Alerts continuously Do FDA, Freedom of Information
Staff (HFI-35), 5600 Fishers
Lane, Rockville, MD 20857,
or via Internet at
www.fda.gov/ora/fiars/ora_
import_alerts.html
Investigations Operations Manual (PB96- May 1996 Do NTIS or via Internet at
913399) www.fda.gov/ora/inspect_ref/
iom/iomtc.html
Laboratory Procedures Manual June 1994 Do FDA, Division of Field
Science (HFC-141), 5600
Fishers Lane, rm. 12-41,
Rockville, MD 20857, ATTN:
Denise I. Jones or via
Internet at www.fda.gov/ora/
science_ref/lpm/lpmtc.html
Regulatory Procedures Manual (PB97- August 1997 Do NTIS or via Internet at
196182) www.fda.gov/ora/compliance_
ref/rpm/rpmtc.html
Guide to Inspections of Bulk May 1994 Do NTIS or via Internet at
Pharmaceutical Chemicals (PB96- www.fda.gov/ora/inspect_ref/
127154) igs/iglist.html
Guide to Inspections of Pharmaceutical July 1993 Do Do
Quality Control Laboratories (PB96-
127279)
Guide to Inspections of July 1993 Do Do
Microbiological Pharmaceutical
Quality Control Laboratories (PB96-
127287)
Guide to Inspections of Validation of July 1993 Do Do
Cleaning Processes (PB96-127246)
Guide to Inspections of Lyophilization July 1993 Do Do
of Parenterals (PB96-127253)
Guide to Inspections of High Purity July 1993 Do Do
Water Systems (PB96-127261)
Guide to Inspections of Dosage Form October 1993 Do Do
Drug Manufacturers-CGMPs (PB96-
127212)
Guide to Inspections of Oral Solid January 1994 Do Do
Dosage Forms Pre/Post Approval Issues
for Development and Validation (PB96-
127345)
Guide to Inspections of Topical Drug July 1994 Do Do
Products (PB96-127394)
Guide to Inspections of Sterile Drug July 1994 Do Do
Substance Manufacturers (PB96-127295)
Guide to Inspections of Oral Solutions August 1994 Do Do
and Suspensions (PB96-127147)
Guide to Inspections of Nutritional February 1995 Do Do
Labeling and Education Act (NLEA)
Requirements (PB96-127378)
Guide to Inspections of Interstate April 1995 Do Do
Carriers and Support Facilities (PB96-
127386)
Guide to Inspections of Dairy Product April 1995 Do Do
Manufacturers (PB96-127329)
Guide to Inspections of Miscellaneous May 1995 Do Do
Foods Vol. I (PB96-127220)
Guide to Inspections of Miscellaneous September 1996 Do Do
Foods Vol. II (PB97-196133)
Guide to Inspections of Low Acid November 1996 Do Do
Canned Foods Manufacturers, Part 1--
Administrative Procedures/Scheduled
Processes (PB97-196141)
[[Page 9842]]
Guide to Inspections of Low Acid April 1997 Do Do
Canned Foods Manufacturers, Part 2--
Processes/Procedures (PB97-196158)
Guide to Inspections of Cosmetic February 1995 Do Do
Product Manufacturers (PB96-127238)
Guide to Inspections of Blood Banks September 1994 Do Do
(PB96-127303)
Guide to Inspections of Source Plasma December 1994 Do Do
Establishments (PB96-127360)
Guide to Inspections of Infectious June 1996 Do Do
Disease Marker Testing Facilities
(PB96-199476)
Biotechnology Inspections Guide (PB96- November 1991 Do Do
127402)
Guide to Inspections of Computerized February 1983 Do Do
Systems in Drug Processing (PB96-
127337)
Guide to Inspections of Foreign September 1995 Do Do
Medical Device Manufacturers (PB96-
127311)
Guide to Inspections of Foreign May 1996 Do Do
Pharmaceutical Manufacturers (PB96-
199468)
----------------------------------------------------------------------------------------------------------------
IX. International Conference on Harmonization Guidances (CDER)
----------------------------------------------------------------------------------------------------------------
How to Obtain a Hard Copy of
Grouped by Intended the Document (Name and
Name of Document Date of Issuance User or Regulatory Address, Phone, FAX, E-mail,
Activity or Internet)
----------------------------------------------------------------------------------------------------------------
E1A The Extent of Population Exposure March 1, 1995 Do Do
to Assess Clinical Safety: for Drugs
Intended for Long-Term Treatment of
Non-Life-Threatening Conditions
E2A Clinical Safety Data Management: March 1, 1995 Do Do
Definitions and Standards for
Expedited Reporting
E2B Data Elements for Transmission of October 1, 1996 Do Do
Individual Case Safety Reports
E2C Clinical Safety Data Management: May 19, 1997 Do Do
Periodic Safety Update Reports for
Marketed Drugs
E3 Structure and Content of Clinical July 17, 1996 Do Do
Study Reports
E4 Dose-Response Information to November 9, 1994 Do Do
Support Drug Registration
E5 Ethnic Factors in the Acceptability July 31, 1997 Do Do
of Foreign Clinical Data
E6 Good Clinical Practices; May 9, 1997 Do Do
Consolidated Guideline
E7 Studies in Support of Special August 2, 1994 Do Do
Populations: Geriatrics
E8 General Considerations for Clinical May 30, 1997 Do Do
Trials
E9 Statistical Principles for Clinical May 9, 1997 Do Do
Trials
M3 Timing of Nonclinical Studies for May 2, 1997 Do Do
the Conduct of Human Clinical Trials
for Pharmaceuticals
Q1A Stability Testing of New Drug September 22, 1994 Do Do
Substances and Products
Q2A Text on Validation of Analytical March 1, 1995 Do Do
Procedures
Q3A Impurities in New Drug Substances January 4, 1996 Do Do
Q5A Biotechnological/Biological May 10, 1996 Do Do
Pharmaceutical Products; Viral Safety
Evaluation
Q6A Specifications; Test Procedures November 25, 1997 Do Do
and Acceptance Criteria for New Drug
Substances and New Drug Products
Chemical Substances
Q1B Photostability Testing of New Drug May 16, 1997 Do Do
Substances and Products
Q1C Stability Testing for New Dosage May 9, 1997 Do Do
Forms
Q2B Validation of Analytical May 19,1997 Do Do
Procedures: Methodology
Q3B Impurities in New Drug Products May 19, 1997 Do Do
Q5B Quality of Biotechnology Products: February 23, 1996 Do Do
Analysis of the Expression Construct
in Cells Used for Production of r-DNA
Derived Protein Products
Q3C Impurities: Residual Solvents May 2, 1997 Do Do
[[Page 9843]]
Q5C Quality of Biotechnological July 10, 1996 Do Do
Products: Stability Testing of
Biotechnology/Biological Products
Q5D Quality of Biotechnological/ May 2, 1997 Do Do
Biological Products: Derivation and
Characterization of Cell Substrates
Used for Production of
Biotechnological/Biological Products
S1A The Need for Long-Term Rodent March 1, 1996 Do Do
Carcinogenicity Studies of
Pharmaceuticals
S3A Toxicokinetics: The Assessment of March 1, 1995 Do Do
Systemic Exposure in Toxicity Studies
S5A Detection of Toxicity to September 22, 1994 Do Do
Reproduction for Medicinal Products
S1C Dose Selection for Carcinogenicity March 1, 1995 Do Do
Studies of Pharmaceuticals
S1C (R) Carcinogenicity Studies of April 2, 1997 Do Do
Pharmaceuticals: Addendum to Dose
Selection
S2A Specific Aspects of Regulatory April 24, 1996 Do Do
Genotoxicity Tests for
Pharmaceuticals
S3B Pharmacokinetics: Guidance for March 1, 1995 Do Do
Repeated Dose Tissue Distribution
Studies
S2B Genotoxicity: Standard Battery April 3, 1997 Do Do
Testing
S4A Duration of Chronic Toxicity November 18, 1997 Do Do
Testing in Animals (Rodent and
Nonrodent Toxicity)
S5B Detection of Toxicity to April 5, 1996 Do Do
Reproduction for Medicinal Products:
Addendum on Toxicity to Male
Fertility
S6 Preclinical Testing of April 4, 1997 Do Do
Biotechnology-Derived Pharmaceuticals
----------------------------------------------------------------------------------------------------------------
Dated: February 20, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-4916 Filed 2-25-98; 8:45 am]
BILLING CODE 4160-01-F