[Federal Register Volume 64, Number 111 (Thursday, June 10, 1999)]
[Notices]
[Pages 31228-31280]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-14752]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N-0046]
Annual Comprehensive List of 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 an annual
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.
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
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Information on where to obtain a single copy of
listed guidance documents is provided for each agency Center
individually in the specific Center's list of guidance documents.
FOR FURTHER INFORMATION CONTACT: Lisa M. Helmanis, Office of Policy
(HF-22), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-827-3480.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of February 27, 1997 (62 FR 8961), FDA
published a notice announcing its 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 an
annual comprehensive list of guidance documents and quarterly updates
that list all guidance documents that were issued and withdrawn during
that quarter, including ``Level 2'' guidance documents.
On June 1, 1998, the President instructed all Federal agencies to
ensure the use of ``plain language'' in all new documents. As part of
this initiative,
[[Page 31229]]
FDA uses the principles of ``plain language'' set forth by the
President when writing its guidance documents. The agency seeks public
comment on the clarity of its guidances.
The following comprehensive list of guidance documents represents
all guidances currently in effect. This comprehensive list is
maintained on the FDA World Wide Web home page. This list will be
updated and published annually in the Federal Register. The guidance
documents on this comprehensive list 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.
II. Guidance Documents Issued by the Center for Biologics
Evaluation and Research (CBER)
----------------------------------------------------------------------------------------------------------------
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 industry Training, and Manufacturers
Assistance (HFM-40), CBER,
Food and Drug
Administration, 1401
Rockville Pike, Rockville,
MD 20852-1448, 1-800-835-
4709 or 301-827-1800, FAX
Information System: 1-888-
CBER-FAX (within U.S.) or
301-827-3844 (outside U.S.
and local to Rockville, MD).
Internet: 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
Requirements for Computerization of
Blood Establishments
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
[[Page 31230]]
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
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 August 19, 1993 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
[[Page 31231]]
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)
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, Source
Plasma 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
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
[[Page 31232]]
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
Guide to Inspections of Blood Banks, September 1, 1994 FDA personnel 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 FDA regulated Do
Related Fatalities and Donation industry
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--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
[[Page 31233]]
Guidance for Industry--Screening and July 29, 1997 Do Do
Testing of Donors of Human Tissue
Intended for Transplantation
Guidance for Industry--Donor Screening August 15, 1997 Do Do
for Antibodies to HTLV-II
Draft 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
Draft 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
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
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 31234]]
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 In Vitro Diagnostic Reagent December 6, 1986 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
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
Letter to Manufacturers of Immune October 3, 1994 Do Do
Globulin Intravenous (Human) (IGIV),
Aseptic Meningitis Syndrome
To Manufacturers of Immune Globulin December 27, 1994 Do Do
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 Drug/ May 9, 1996 Do Do
Biological/Device Products, Bovine
Spongiform Encephalopathy (BSE)
To Manufacturers: Implementation of June 13, 1996 Do Do
Testing for Hepatitis C Virus RNA by
Manufacturers: Implementation of
Testing for Hepatitis C Virus RNA by
Polymerase Chain Reaction (PCR) of
Intramuscular Immune Globulin
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 Plasma Fractionators--CBER's View May 29, 1997 Do Do
on Product Recalls Conducted by the
Plasma Fractionation Industry
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)
[[Page 31235]]
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
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
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
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
Reviewer Guidance for a Premarket January 13, 1997 Do Do
Notification Submission for Blood
Establishment Computer Software
Compliance Program Guidance Manual 1994 Do National Technical
(Drugs and Biologics) Information Service (NTIS),
5285 Port Royal Rd.,
Springfield, VA 22161, 703-
605-6050 (Publication No. 94-
920699)
Guidance for Industry: Industry- November 1997 FDA regulated Office of Communication,
Supported Scientific and Educational industry Training, and Manufacturers
Activities Assistance (HFM-40), CBER,
Food and Drug
Administration, 1401
Rockville Pike, Rockville,
MD 20852-1448, 1-800-835-
4709 or 301-827-1800, FAX
Information System: 1-888-
CBER-FAX (within U.S.) or
301-827-3844 (outside U.S.
and local to Rockville, MD).
Internet: http://www.fda.gov/
cber
To Biologic Product Manufacturers-- December 11, 1997 Do Do
Withdrawal of Human Blood-Derived
Materials Because Donors Diagnosed
With, or At Increased Risk For, CJD
To Allergenic Extract Manufacturers-- December 23, 1997 Do Do
Standardized Grass Pollen Extracts
Draft Guidance for Industry: Promoting December 1997 Do Do
Medical Products in a Changing
Healthcare Environment; I. Medical
Product Promotion by Healthcare
Organizations or Pharmacy Benefits
Management Companies (PBMS)
Dear Doctor Letter--Difficulty in January 28, 1998 Health care providers Do
Obtaining Immune Globulin Intravenous
(Human)
Guidance for Industry: Year 2000 Date January 1998 FDA regulated Do
Change for Computer Systems and industry
Software Applications Used in the
Manufacture of Blood Products
[[Page 31236]]
Draft Guidance for Industry: Efficacy January 1998 Do Do
Studies to Support Marketing of
Fibrin Sealant Products Manufactured
for Commercial Use
Draft Guidance for Industry: Container January 1998 Do Do
and Closure Integrity Testing in Lieu
of Sterility Testing as a Component
of the Stability Protocol for Sterile
Products
Draft Guidance for Industry: Clinical February 1998 Do Do
Development of Programs for Drugs,
Devices and Biological Products
Intended for Treatment of
Osteoarthritis (OA)
Draft Guidance for Industry: March 1998 Do Do
Manufacturing, Processing or Holding
Active Pharmaceutical Ingredients
Guidance for Industry: Guidance for March 1998 Do Do
Human Somatic Cell Therapy and Gene
Therapy
Dear Doctor Letter--Standardized Grass May 11, 1998 Health care providers Do
Pollen Extracts
Draft Guidance for Industry: May 1998 FDA regulated Do
Instructions for Submitting industry
Electronic Lot Release Protocols to
the Center for Biologics Evaluation
and Research
Draft Guidance for Industry: Pilot May 1998 Do Do
Program for Electronic
Investigational New Drug (eIND)
Applications for Biological Products
Draft Guidance for Industry: May 1998 Do Do
Electronic Submissions of Case Report
Forms (CRFs), Case Report Tabulations
(CRTs) and Data to the Center for
Biologics Evaluation and Research
Draft Guidance for Industry: May 1998 Do Do
Electronic Submissions of a Biologics
License Application (BLA) or Product
License Application (PLA)/
Establishment License Application
(ELA) to the Center for Biologics
Evaluation and Research
Guidance for Industry: Submitting and May 1998 Do Do
Reviewing Complete Responses to
Clinical Holds
Guidance for Industry: Classifying May 1998 Do Do
Resubmissions in Response to Action
Letters
Guidance for Industry: May 1998 Do Do
Pharmacokinetics in Patients with
Impaired Renal Function--Study
Design, Data Analysis and Impact on
Dosing and Labeling
Guidance for Industry: Standards for May 1998 Do Do
the Prompt Review of Efficacy
Supplements, Including Priority
Efficacy Supplements
Guidance for Industry: Providing May 1998 Do Do
Clinical Evidence of Effectiveness
for Human Drugs and Biological
Products
Draft Guidance for Industry: Stability June 1998 Do Do
Testing of Drug Substances and Drug
Products
ICH Draft Guidance on Specifications: June 9, 1998 Do Do
Test Procedures and Acceptance
Criteria for Biotechnological/
Biological Products
ICH Guidance on Ethnic Factors in the June 10, 1998 Do Do
Acceptability of Foreign Clinical
Data
Draft Guidance for Industry: Exports June 12, 1998 Do Do
and Imports Under the FDA Export
Reform and Enhancement Act of 1996
Guidance for Industry: Qualifying for June 1998 Do Do
Pediatric Exclusivity Under Section
505A of the Federal Food, Drug, and
Cosmetic Act
Guidance for Industry: Errors and June 1998 Do Do
Accidents Regarding Saline Dilution
of Samples Used for Viral Marker
Testing
Draft Guidance for Industry: In the July 1998 Do Do
Manufacture and Clinical Evaluation
of In Vitro Tests to Detect Nucleic
Acid Sequences of Human
Immunodeficiency Virus Type 1
[[Page 31237]]
Draft Guidance for Industry: For the July 1998 Do Do
Submission of Chemistry,
Manufacturing and Controls and
Establishment Description Information
for Human Blood and Blood Components
Intended for Transfusion or for
Further Manufacture and for the
Completion of the FDA Form 356h
``Application to Market a New Drug,
Biologic or an Antibiotic Drug for
Human Use''
Guidance for Industry: Implementation July 1998 Do Do
of Section 126 of the Food and Drug
Administration Modernization Act of
1997--Elimination of Certain Labeling
Requirements
Guidance for Industry: Environmental July 1998 Do Do
Assessment of Human Drug and
Biologics Applications
Draft Guidance for Industry: July 1998 Do Do
Recommendations for Collecting Red
Blood Cells by Automated Apheresis
Methods
Dear Colleague Letter--Use of August 12, 1998 Health care providers Do
Haemophilus influenzae Conjugate
Vaccines in Combination With DTaP in
Infants
Dear Doctor Letter--Albumin Use in August 19, 1998 Do Do
Seriously Ill Patients
Draft Guidance for Industry: Content August 1998 FDA regulated Do
and Format of Chemistry, industry
Manufacturing and Controls
Information and Establishment
Description Information for an
Allergenic Extract or Allergen Patch
Test
Draft Guidance for Industry: August 1998 Do Do
Submission of Abbreviated Reports and
Synopses in Support of Marketing
Applications
ICH Guidance on Statistical Principles September 16, 1998 Do Do
for Clinical Trials
ICH Guidance on Quality of September 21, 1998 Do Do
Biotechnological/Biological Products:
Derivation and Characterization of
Cell Substrates Used for Production
of Biotechnological/Biological
Products
ICH Guidance on Viral Safety September 24, 1998 Do Do
Evaluation of Biotechnology Products
Derived From Cell Lines of Human or
Animal Origin
Change to the Guidance Entitled September 8, 1998 Do Do
``Revised Precautionary Measures to
Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob
Disease (CJD) by Blood and Blood
Products''--Information Sheet
Guidance for Industry: Current Good September 1998 Do Do
Manufacturing Practice for Blood and
Blood Components: (1) Quarantine and
Disposition of Units from Prior
Collections from Donors with
Repeatedly Reactive Screening Tests
for Antibody to Hepatitis C Virus
(Anti-HCV); (2) Supplemental Testing,
and the Notification of Consignees
and Blood Recipients of Donor Test
Results for Anti-HCV
Draft Guidance for Industry: September 1998 Do Do
Submitting Debarment Certification
Statements
Guidance for Industry: How to Complete September 1998 Do Do
the Vaccine Adverse Reporting System
Form (VAERS-1)
Guidance for Industry: Fast Track Drug September 1998 Do Do
Development Programs--Designation,
Development, and Application Review
CBER's Year 2000 Letter October 27, 1998 Do Do
Draft Guidance for Industry: October 1998 Do Do
Developing Medical Imaging Drugs and
Biologics
Dear Blood Bank/Transfusion Service November 3, 1998 Do Do
Director Letter: Hepatitis C Virus
Risk
Dear Doctor Letter--Important Drug November 13, 1998 Health care providers Do
Warning: Immune Globulin Intravenous
(Human)
Draft Guidance for Industry: Content November 1998 FDA regulated Do
and Format of Chemistry, industry
Manufacturing and Controls
Information and Establishment
Description Information for a
Biological In Vitro Diagnostic
Product
[[Page 31238]]
Draft Guidance for Industry: In Vivo November 1998 Do Do
Drug Metabolism/Drug Interaction
Studies--Study Design, Data Analysis
and Recommendations for Dosing and
Labeling
Draft Document: United States Industry December 1997 Do Do
Consensus Standard for the Uniform (released
Labeling of Blood and Blood November 1998)
Components Using ISBT 128
Draft Guidance for Industry: General November 1998 Do Do
Considerations for Pediatric
Pharmacokinetic Studies for Drugs and
Biological Products
To Viral Vaccine IND Sponsors--Use of December 18, 1998 Do Do
PCR-Based Reverse Transcriptase Assay
Guidance for Industry: FDA Approval of December 1998 Do Do
New Cancer Treatment Uses for
Marketed Drug and Biological Products
Draft Guidance for Industry: Gamma December 1998 Do Do
Irradiation of Blood and Blood
Components: A Pilot Program for
Licensing
Draft Guidance for Industry: Content December 1998 Do Do
and Format of Geriatric Labeling
Dear Healthcare Provider: Important January 25, 1999 Health care providers Do
Drug Warning: Safety Information
Regarding the use of Abbokinase
(Urokinase)
Guidance for Industry: Content and January 1999 FDA regulated Do
Format of Chemistry, Manufacturing industry
and Controls Information and
Establishment Description Information
for a Vaccine or Related Product
Guidance on Amended Procedures for January 1999 Do Do
Advisory Panel Meetings
Guidance for Industry: Providing January 1999 Do Do
Regulatory Submissions in Electronic
Format--General Considerations
Guidance for Industry: Population February 1999 Do Do
Pharmacokinetics
Guidance for Industry: For the February 1999 Do Do
Submission of Chemistry,
Manufacturing and Controls and
Establishment Description Information
for Human Plasma-Derived Biological
Products, Animal Plasma or Serum-
Derived Products
Guidance for Industry: Clinical February 1999 Do Do
Development Programs for Drugs,
Devices and Biological Products for
the Treatment of Rheumatoid Arthritis
(RA)
Dear Colleague Letter: Voluntary February 4, 1999 Health care providers Do
Recall of Tripedia, DTaP Vaccine
----------------------------------------------------------------------------------------------------------------
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)
----------------------------------------------------------------------------------------------------------------
Guidance on Medical Device Tracking February 19, 1998 Office of Compliance Division of Small
(Docket No. 98D-0132) (OC) Manufacturers Assistance,
CDRH, Food and Drug
Administration, 1-800-638-
2041 or 301-827-0111 or
(FAX) Facts on Demand at 1-
800-899-0381 or Internet at
http://www.fda.gov/cdrh
Guidance on Lead Wires and Patient March 9, 1998 OC Do
Cables
Global Harmonization Task Force: Draft October 28, 1998 OC Do
Document on the Essentials Principles
of Safety and Performance of Medical
Devices on a Global Basis
Medical Devices: Draft Global July 16, 1998 OC Do
Harmonization Task Force Study Group
3 Process Validation Guidance (Draft)
[[Page 31239]]
Letter to Medical Device Manufacturer February 14, 1995 OC Do
on Pentium Processors
Guideline for Preparing Notices of November 1, 1985 OC/Bioresearch Do
Availability of Investigational Monitoring (BIMO)
Medical Devices
All Diagnostic Ultrasound February 24, 1986 OC/Division of Do
Manufacturers and Importers-Exemption Enforcement I (DOEI)
from Reporting Under 21 CFR 1002
General Principles of Software June 9, 1997 OC/DOEI Do
Validation; Draft Guidance
Exemption from Reporting and September 16, 1981 OC/DOEI Do
Recordkeeping Requirements for
Certain Sunlamp Product Manufacturers
Clarification of Radiation Control March 1, 1989 OC/DOEI Do
Regulations for Diagnostic X-ray
Equipment (FDA 89-8221)
A Guide for the Submission of March 1, 1996 OC/DOEI Do
Abbreviated Radiation Safety Reports
on Cephalometric X-ray Devices:
Defined as Dental Units with an
Attachment for Mandible Work that
Holds a Cassette and Beam Limiting
Device
A Guide for the Submission of March 1, 1996 OC/DOEI Do
Abbreviated Radiation Safety Reports
on Image Receptor Support Devices for
Mammographic X-ray Systems
A Guide for the Submission of an March 1, 1996 OC/DOEI Do
Abbreviated Radiation Safety Report
on X-ray Tables, Cradles, Film
Changers or Cassette Holders Intended
for Diagnostic Use
Guide for the Submission of Initial January 1, 1982 OC/DOEI Do
Reports on Diagnostic X-Ray Systems
and their Major Components
Guideline for the Manufacture of In January 10, 1994 OC/DOEI Do
Vitro Diagnostic Products
Letter to Medical Device Industry on May 17, 1993 OC/DOEI Do
Endoscopy and Laparoscopy Accessories
(Galdi)
Manufacturers/Assemblers of Diagnostic October 13, 1993 OC/DOEI Do
X-ray Systems: Enforcement Policy for
Positive-Beam Limitation (PBL)
Requirements in 21 CFR 1020.31(g)
Retention of Records Required by 21 August 24, 1981 OC/DOEI Do
CFR 1002
All U.S. Condom Manufacturers, April 7, 1987 OC/Division of Do
Importers and Repackagers Enforcement II
(DOEII)
Letter to Ophthalmologists about June 27, 1997 OC/DOEII Do
Lasers for Refractive Surgery
Manufacturers and Initial Distributors May 23, 1996 OC/DOEII Do
of Hemodialyzers
Manufacturers and Users of Lasers for October 10, 1996 OC/DOEII Do
Refractive Surgery
Shielded Trocars and Needles Used for August 23, 1996 OC/DOEII Do
Abdominal Access During Laparoscopy
Prospective Manufacturers of Barrier October 31, 1996 OC/DOEII Do
Devices Used During Oral Sex for STD
Protection
Condoms: Inspection and Sampling at April 8, 1987 OC/DOEII Do
Domestic Manufacturers and of all
Repackers; Sampling from all
Importers (Damaska Memo to Field on 4/
8/87)
Guide for Preparing Product Reports September 1, 1995 OC/DOEII Do
for Lasers and Products Containing
Lasers
Hazards of Volume Ventilators and September 15, 1993 OC/DOEII Do
Heated Humidifiers
Latex Labeling Letter (Johnson) March 18, 1993 OC/DOEII Do
Letter--Condom Manufacturers and April 5, 1994 OC/DOEII Do
Distributors (included in Condom
Packet #398)
Letter to Industry, Powered Wheelchair May 10, 1993 OC/DOEII Do
Manufacturers from R. M. Johnson
Letter to Manufacturers/Repackers April 22, 1994 OC/DOEII Do
Using Cotton
Manufacturers and Initial Distributors February 3, 1994 OC/DOEII Do
of Sharps Containers and Destroyers
Used by Health Care Professionals
Compliance Guide for Laser Products September 1, 1985 OC/DOEII Do
(FDA 86-8260)
Dental Handpiece Sterilization (Dear September 28, 1992 OC/DOEII Do
Doctor Letter)
[[Page 31240]]
Ethylene Oxide; Ethylene Chlorohydrin; June 23, 1978 OC/DOEII Do
and Ethylene Glycol; Proposed Maximum
Residue Limits and Maximum Levels of
Exposure
Letter--Manufacturers, Distributors February 23, 1994 OC/DOEII Do
and Importers of Condom Products
(included in Condom Packet #398)
Letter--Manufacturers, Importers, and February 13, 1989 OC/DOEII Do
Repackagers of Condoms for
Contraception or Sexually-Transmitted
Disease Prevention (Holt) (included
in Condom Packet #398)
Regulatory Requirements for Medical September 1, 1996 OC/DOEII Do
Gloves--A Workshop Manual FDA
Publication No. 96-4257
Standard Specification for Rubber October 28, 1983 OC/DOEII Do
Contraceptives (Condoms) (included in
Condom Packet #398)
Pesticide Regulation Notice 94-4 June 30, 1994 OC/DOEII Do
Interim Measures for the Registration
of Antimicrobial Products/Liquid
Chemical Germicides with Medical
Device Use Claims
Open Door Operation of Microwave Ovens March 28, 1980 OC/Division of Do
as a Result of Oven Miswiring Enforcement III
(DOEIII)
Guide for Preparing Abbreviated September 1, 1996 OC/DOEIII Do
Reports of Microwave and RF Emitting
Electronic Products Intended for
Medical Use
Final Design Control Inspectional March 1, 1997 OC/DOEIII Do
Strategy
Abbreviated Reports on Radiation August 1, 1995 OC/DOEIII Do
Safety for Microwave Products (Other
Than Microwave Ovens)--E.G. Microwave
Heating, Microwave Diathermy, RF
Sealers, Induction, Dielectric
Heaters, Security Systems
Design Control Guidance for Medical March 11, 1997 OC/DOEIII Do
Device Manufacturers
Abbreviated Reports on Radiation August 1, 1995 OC/DOEIII Do
Safety of Non-Medical Ultrasonic
Products
Application for a Variance from 21 CFR March 1, 1987 OC/DOEIII Do
1040.11(c) for a Laser Light Show,
Display, or Device
Computerized Devices/Processes May 1, 1992 OC/DOEIII Do
Guidance--Application of the Medical
Device GMP to Computerized Devices
and Manufacturing Processes
Guidance for the Submission of Cabinet February 1, 1975 OC/DOEIII Do
X-Ray System Reports Pursuant to 21
CFR 1020.40
Guide for Preparing Annual Reports on October 1, 1987 OC/DOEIII Do
Radiation Safety Testing of
Electronic Products (General)
Guide for Preparing Annual Reports on September 1, 1995 OC/DOEIII Do
Radiation Safety Testing of Mercury
Vapor Lamps (replaces FDA 82-8127)
Guide for Preparing Annual Reports on September 1, 1995 OC/DOEIII Do
Radiation Safety Testing of Sunlamps
and Sunlamp Products (replaces FDA 82-
8127)
Guide for Preparing Product Reports on September 1, 1995 OC/DOEIII Do
Sunlamps and Sunlamp Products (21 CFR
1002)
Guide for Preparing Reports on March 1, 1985 OC/DOEIII Do
Radiation Safety of Microwave Ovens
Guide for Submission of Information on April 1, 1971 OC/DOEIII Do
Accelerators Intended to Emit X-
Radiation Required Pursuant to 21 CFR
1002.10
Guide for Submission of Information on April 30, 1974 OC/DOEIII Do
Analytical X-Ray Equipment Required
Pursuant to 21 CFR 1002.10
Guide for Submission of Information on September 1, 1980 OC/DOEIII 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 OC/DOEIII Do
Industrial X-Ray Equipment Required
Pursuant to 21 CFR 1002.10
Guide for the filing of Annual Reports July 1, 1980 OC/DOEIII Do
for X-Ray Components and Systems
Guide for the Submission of Initial September 1, 1984 OC/DOEIII Do
Reports on Computed Tomography X-Ray
Systems
[[Page 31241]]
Impact Resistant Lenses: Questions and September 1, 1987 OC/DOEIII Do
Answers (FDA 87-4002) (see shelf #
460)
Imports Radiation-Producing Electronic November 1, 1988 OC/DOEIII Do
Products (FDA 89-8008)
Information Requirements for Cookbooks October 31, 1988 OC/DOEIII Do
and User and Service Manuals
Keeping Medical Devices Safe from July 1, 1995 OC/DOEIII Do
Electromagnetic Interference
Keeping Up With the Microwave March 1, 1990 OC/DOEIII Do
Revolution (FDA Pub No. 91-4160)
Laser Light Show Safety--Who's May 1, 1986 OC/DOEIII Do
Responsibility (FDA 86-8262)
Letter to All Foreign Manufacturers May 28, 1981 OC/DOEIII Do
and Importers of Electronic Products
for Which Applicable FDA Performance
Standards Exist
Letter to Trade Association: ReUse of December 27, 1995 OC/DOEIII Do
Single-use or Disposable Medical
Devices
Letter: Changes in Regulations October 27, 1995 OC/DOEIII Do
Concerning Records and Reports on
Radiation-Emitting Electronic
Products
Medical Device Electromagnetic OC/DOEIII Do
Interference Issues, Problem Reports,
Standards, and Recommendations
Medical Devices and EMI: The FDA January 1, 1995 OC/DOEIII Do
Perspective
Policy on Lamp Compatibility September 2, 1986 OC/DOEIII Do
(sunlamps)
Policy on Maximum Timer Interval and August 21, 1986 OC/DOEIII Do
Exposure Schedule for Sunlamp
Products
Policy on Warning Label Required on June 25, 1985 OC/DOEIII Do
Sunlamp Products
Quality Assurance Guidelines for February 1, 1991 OC/DOEIII Do
Hemodialysis Devices
Quality Control Guide for Sunlamp March 1, 1988 OC/DOEIII Do
Products (FDA 88-8234)
Quality Control Practices for May 1, 1980 OC/DOEIII Do
Compliance with the Federal Mercury
Vapor Lamp Performance Standard
Reporting and Compliance Guide for October 1, 1995 OC/DOEIII Do
Television Products including Product
Report, Supplemental Report,
Radiation Safety Abbreviated Report,
Annual Report, Information and
Guidance
Reporting Guide for Laser Light Shows September 1, 1995 OC/DOEIII Do
and Displays (21 CFR 1002) (FDA 88-
8140)
Reporting Guide for Product Reports on September 1, 1995 OC/DOEIII Do
High Intensity Mercury Vapor
Discharge Lamps (21 CFR 1002)
Reporting of New Model Numbers to June 14, 1983 OC/DOEIII Do
Existing Model Families
Revised Guide for Preparing Annual September 1, 1995 OC/DOEIII Do
Reports on Radiation Safety Testing
of Laser and Laser Light Show
Products (replaces FDA 82-8127)
Safety of Electrically Powered September 18, 1996 OC/DOEIII Do
Products: Letter To Medical Device
and Electronic Product Manufacturers
From Lillian Gill & BHB correction
memo
Suggested State Regulations for January 1, 1982 OC/DOEIII Do
Control of Radiation--Volume II
Nonionizing Radiation--Lasers (FDA
Pub No. 83-8220)
Unsafe Patient Lead Wires and Cables September 3, 1993 OC/DOEIII Do
Guide for Preparing Annual Reports for September 1, 1996 OC/DOEIII Do
Ultrasonic Therapy Products
Guide for Preparing Product Reports September 1, 1996 OC/DOEIII Do
for Medical Ultrasound Products
Guide for Preparing Product Reports August 1, 1996 OC/DOEIII Do
for Ultrasonic Therapy Products
(physical therapy only)
Guide for Establishing and Maintaining March 1, 1988 OC/DOEI & III Do
a Calibration Constancy
Intercomparison System for Microwave
Oven Compliance Survey Instruments
(FDA 88-8264)
The FDA Export Reform and Enhancement October 1, 1996 OC/Division of Do
Act of 1996/Export Certification Program Operations
(DPO)
[[Page 31242]]
Sec. 300.600 Commercial Distribution September 24, 1987 OC/Office of the Do
with Regard to Premarket Notification Director (OD)
(Section 510(k)) (CPG 7124.19)
Global Harmonization Task Force: August 31, 1998 OC/Office of Do
Availability of Draft Documents on Surveillance and
Adverse Event and Vigilance Reporting Biometrics (OSB)
of Medical Device Events
Commercial Distribution/Exhibit Letter April 10, 1992 OC/Other (OT) Do
(Use instead of Hile letter)
(Display)
Working Draft of the Current Good July 1, 1995 OC/OT Do
Manufacturing Practice (CGMP) Final
Rule
Guidance for the Medical Device November 6, 1998 ODE Do
Industry on PMA Shell Development and
Modular Review
Medical Devices Containing Materials November 6, 1998 ODE Do
Derived from Animal Sources (Except
In Vitro Diagnostic Devices),
Guidance for FDA Reviewers and
Industry
Frequently Asked Questions on the New October 22, 1998 ODE Do
510(k) Pardigm
Guidance to Industry Supplements to May 20, 1998 ODE Do
Approved Applications for Class III
Medical Devices: Use of Published
Literature, Use of Previously
Submitted Material, and Priority
Review
Convenience Kits Interim Regulatory May 20, 1997 ODE Do
Guidance
Kit Certification for 510(k)s July 1997 ODE Do
Guidance for Industry--Contents of a July 27, 1998 ODE Do
Product Development Protocol
Guidance for the Content of Premarket May 28, 1998 ODE Do
Submissions for Software Contained in
Medical Devices (replaces Reviewer
Guidance for Computer-Controlled
Medical Devices Undergoing 510(k)
Review 8/29/91)
New Model Medical Device Development June 3, 1998 ODE Do
Process
Modifications to Devices Subject to August 6, 1998 ODE Do
Premarket Approval--the PMA
Supplement Decision Making Process
Guidance for Off-the-Shelf Software August 17, 1998 ODE Do
Use in Medical Devices
PMA/510(k) Expedited Review--Guidance March 20, 1998 ODE Do
for Industry and CDRH Staff
Guidance on Amended Procedures for March 30, 1998 ODE Do
Advisory Panel Meetings
`Real-Time' Review Program for April 22, 1997 ODE Do
Premarket Approval Application (PMA)
Supplements
A New 510(k) Paradigm--Alternate March 30, 1998 ODE Do
Approaches to Demonstrating
Substantial Equivalence in Premarket
Notifications
Freedom of Information/510(K) Process May 15, 1997 ODE Do
Changes
Guidance for Submitting January 1, 2000 ODE Do
Reclassification Petition
Product Development Protocol October 1, 1997 ODE Do
Guidance on PMA Interactive Procedures February 19, 1998 ODE Do
for Day-100 Meetings and Subsequent
Deficiencies--for Use by CDRH and
Industry (Docket No. 98D-0079)
Procedures for Class II Device February 25, 1998 ODE Do
Exemptions from Premarket
Notification Guidance for Industry
and CDRH Staff (Docket No. 98D-0083)
New section 513(f)(2)--Evaluation of February 19, 1998 ODE Do
Automatic Class III Designation:
Guidance for Industry and CDRH Staff
(Docket No. 98D-0082)
SMDA Changes--Premarket Notification; April 17, 1992 ODE Do
Regulatory Requirements for Medical
Devices (510k) Manual Insert
#D95-2, Attachment A (Interagency September 15, 1995 ODE Do
Agreement between FDA & HCFA)
#D95-2, Attachment B (Criteria for September 15, 1995 ODE Do
Categorization of Investigational
Devices (HCFA)
30-Day Notices and 135-Day PMA February 19, 1998 ODE Do
Supplements for Manufacturing Method
or Process Changes, Guidance for
Industry and CDRH (Docket No. 98D-
0080)
510(k) Quality Review Program (blue March 29, 1996 ODE Do
book memo)
[[Page 31243]]
Distribution and Public Availability October 10, 1997 ODE Do
of PMA Summary of Safety and
Effectiveness Data Packages
Document Review by the Office of the June 6, 1996 ODE Do
Chief Counsel (Blue Book Memo G96-1))
HCFA Reimbursement Categorization September 15, 1995 ODE Do
Determinations for FDA-approved IDEs
ODE Executive Secretary Guidance August 7, 1987 ODE Do
Manual
Determination of Intended Use for February 19, 1998 ODE Do
510(k) Devices: Final Document
(Docket No. 98D-0081)
Letter--Vascular Graft Industry November 22, 1995 ODE Do
(Philip Phillips)
Letter to Industry, Powered Wheelchair/ May 26, 1994 ODE Do
Scooter or Accessory/Component
Manufacturer from Susan Alpert,
Ph.D., M.D.
Preamendments Class III Strategy; April 19, 1994 ODE Do
SXAlpert
4-of-A-Kind PMA's October 1, 1991 ODE Do
Application of the Device Good December 1, 1983 ODE Do
Manufacturing Practice (GMP)
Regulation to the Manufacture of
Sterile Devices
CDRH's 510(k)/IDE/PMA Refuse to Accept/ June 30, 1993 ODE Do
Accept/File Policies (see #D94-1,
#K94-1, & #P94-1)
Classified Convenience Kits April 30, 1993 ODE Do
Color Additive Petitions (p. II-19 of June 1, 1987 ODE Do
PMA Manual)
Color Additive Status List (Inspection February 1, 1989 ODE Do
Operations Manual)
Early Collaboration Meetings Under the February 19, 1998 ODE Do
FDA Modernization Act (FDAMA),
Guidance for Industry and CDRH Staff,
Final Document (Docket No. 98D-0078)
Color Additives for Medical Devices November 15, 1995 ODE Do
(Snesko)
Deciding When to Submit a 510(k) for a January 10, 1997 ODE Do
Change to an Existing Device (see
CDRH F-O-D #1935)
Device Specific Guidance Documents May 11, 1993 ODE Do
(List)
FDA Clinical Investigator Information May 1, 1989 ODE Do
Sheets
FDA Guide for Validation of Biological January 1, 1986 ODE Do
Indicator Incubation Time (Source:
Sterilization Committee; through
Virginia Ross; HFZ-332)
FDA Policy For The Regulation Of November 13, 1989 ODE Do
Computer Products (DRAFT) (See 2099)
Format for IDE Progress Reports January 1, 2000 ODE Do
Guidance for Preparation of PMA August 1, 1992 ODE Do
Manufacturing Information
Guideline for the Monitoring of January 1, 1988 OC/BIMO Do
Clinical Investigations
Guideline on General Principles of May 1, 1987 ODE Do
Process Validation
Guideline on Sterile Drug Products June 1, 1987 ODE Do
Produced by Aseptic Processing
Guideline on Validation of the Limulus December 1, 1987 ODE Do
Amebocyte Lysate (LAL) Test as an End-
Product Endotoxin Test
Indications for Use Statement January 2, 1996 ODE Do
Industry Representatives on Scientific March 27, 1987 ODE Do
Panels
Labeling Reusable Medical Devices for April 1, 1996 ODE Do
Reprocessing in Health Care
Facilities: FDA Reviewer Guidance
(see 1198)
Limulus Amebocute Lysate; Reduction of October 23, 1987 ODE Do
Samples for Testing
Master Files Part III; Guidance on June 1, 1987 ODE Do
Scientific and Technical Information
Memorandum: Electromagnetic June 13, 1995 ODE Do
Compatibility for Medical Devices:
Issues and Solutions
Methods for Conducting Recall June 16, 1978 ODE Do
Effectiveness Checks
Necessary Information for Diagnostic November 24, 1987 ODE Do
Ultrasound 510(k) (Draft)
Perspectives on Clinical Studies for January 1, 2000 ODE Do
Medical Device Submissions
(Statistical)
PMA Review Statistical Checklist January 1, 2000 ODE Do
[[Page 31244]]
Points to Consider in the June 1, 1984 ODE Do
Characterization of Cell Lines Used
to Produce Biological Products (from
John C. Petricciani, M.D.)
Preamendment Class III Devices March 11, 1992 ODE Do
Premarket Notification [510(k)] Status March 7, 1994 ODE Do
Request Form, revised
Premarket Submission Coversheet, January 19, 1995 ODE Do
Instructions, and Survey
Preproduction Quality Assurance September 1, 1989 ODE Do
Planning: Recommendations for Medical
Device Manufacturers (FDA 90-4236)
Proposal for Establishing Mechanisms June 30, 1993 ODE 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 ODE Do
Reviewer Guidance: Labeling Reusable
Medical Devices for Reprocessing in
Health Care Facilities (see 198)
Shelf Life of Medical Devices March 1, 1991 ODE Do
Substantial Equivalence (SE) Decision January 1, 1990 ODE Do
Making Documentation ATTACHED: `SE'
Decision Making Process (Detailed)
i.e. the decision making tree
Suggested Content for Original IDE February 27, 1996 ODE Do
Application Cover Letter--Version 4
Suggestions for Submitting a Premarket April 1, 1993 ODE Do
Approval (PMA) Application
Threshold Assessment of the Impact of January 1, 1990 ODE Do
Requirements for Submission of PMAs
for 31 Medical Devices Marketed Prior
to May 28, 1976
Guidance on IDE Policies and January 20, 1998 ODE Do
Procedures
Viable Bacteriophage in Co2 Laser January 1, 2000 ODE Do
Plume: Aerodynamic Size Distribution
Deciding When to Submit a 510(k) for a January 10, 1997 ODE/blue Do
Change to an Existing Device (blue
book memo #K97-1) (see CDRH F-O-D
#935)
Memorandum of Understanding Regarding August 9, 1996 ODE/blue Do
Patient Labeling Review (blue book
memo #G96-3))
Continued Access to Investigational July 15, 1996 ODE/blue Do
Devices During PMA Preparation and
Review (blue book memo)
510(k) Additional Information July 23, 1993 ODE/blue/510k Do
Procedures (blue book memo #K93-1)
510(k) Refuse to Accept Procedures May 20, 1994 ODE/blue/510k Do
(blue book memo #K94-1)
510(k) Sign-Off Procedures (blue book June 3, 1994 ODE/blue/510k Do
memo #K94-2)
510(k) Sterility Review Guidance and February 12, 1990 ODE/blue/510k Do
Revision of 11/18/1994 (blue book
memo #K90-1)
Cover Letter: 510(k) Requirements November 21, 1995 ODE/blue/510k Do
During Firm-Initiated Recalls;
Attachment A: Guidance on Recall and
Premarket Notification Review
Procedures During Firm-Initiated
Recalls of Legally Marketed Devices
(blue book memo #95-1)
Guidance on the Center for Devices and June 30, 1986 ODE/blue/510k Do
Radiological Health's Premarket
Notification Review Program (blue
book memo #K86-3)
Premarket Notification--Consistency of February 28, 1989 ODE/blue/510k Do
Reviews (blue book memo #K89-1)
Review of 510(k)s for Computer August 29, 1991 ODE/blue/510k Do
Controlled Medical Devices (blue book
memo #K91-1)
Executive Secretaries Guidance Manual August 7, 1987 ODE/blue/gnrl Do
G87-3
Consolidated Review of Submissions for October 19, 1990 ODE/blue/gnrl Do
Diagnostic Ultrasound Equipment,
Accessories and Related Measurement
Devices (blue book memo #G90-2)
Consolidated Review of Submissions for October 19, 1990 ODE/blue/gnrl Do
Lasers and Accessories (blue book
memo #G90-1)
Device Labeling Guidance (blue book March 8, 1991 ODE/blue/gnrl Do
memo 91-1 )
Documentation and Resolution of December 23, 1993 ODE/blue/gnrl Do
Differences of Opinion on Product
Evaluations (blue book memo #G93-1)
[[Page 31245]]
ODE Regulatory Information for the May 15, 1987 ODE/blue/gnrl Do
Office of Compliance--Information
Sharing Procedures (blue book memo
#G87-2)
PMA/510(k) Expedited Review (blue book May 20, 1994 ODE/blue/gnrl Do
memoG94-2)
PMA/510(k) Triage Review Procedures May 20, 1994 ODE/blue/gnrl Do
(blue book memo #G94-1)
Review of Laser Submissions (blue book April 15, 1988 ODE/blue/gnrl Do
memo #G88-1)
Toxicology Risk Assessment Committee August 9, 1989 ODE/blue/gnrl Do
(blue book memo #G89-1)
Use of International Standard ISO- May 1, 1995 ODE/blue/gnrl Do
10993, 'Biological Evaluation of
Medical Devices Part 1: Evaluation
and Testing' (blue book memo)
(Replaces #G87-1 #8294)
Delegation of IDE Actions (blue book April 26, 1988 ODE/blue/ide Do
memo #D88-1)
Goals and Initiatives for the IDE July 12, 1995 ODE/blue/ide Do
Program (blue book memo #D95-1)
IDE Refuse to Accept Procedures (blue May 20, 1994 ODE/blue/ide Do
book memo #D94-1)
Implementation of the FDA/HCFA September 15, 1995 ODE/blue/ide Do
Interagency Agreement Regarding
Reimbursement Categorization of
Investigational Devices, Att. A
Interagency Agreement, Att. B
Criteria for Catergorization of
Investigational Devices, & Att. C-
List (blue book memo #D95-2)
Overdue IDE Annual Progress Report July 23, 1993 ODE/blue/ide Do
Procedures (blue book memo) #D93-1
Review of IDEs for Feasibility Studies May 17, 1989 ODE/blue/ide Do
(blue book memo #D89-1)
Assignment of Review Documents (blue August 24, 1990 ODE/blue/integ Do
book memo #I90-2)
Document Review Processing (blue book February 12, 1992 ODE/blue/integ Do
memo #I91-1)
Integrity of Data and Information May 29, 1991 ODE/blue/integ Do
Submitted to ODE (blue book memo #I91-
2)
Meetings with the Regulated Industry November 20, 1989 ODE/blue/integ Do
(blue book memo #I89-3)
Nondisclosure of Financially Sensitive March 5, 1992 ODE/blue/integ Do
Information (blue book memo #I92-1)
Policy Development and Review February 15, 1990 ODE/blue/integ Do
Procedures (blue book memo #I90-1)
Telephone Communications Between ODE January 29, 1993 ODE/blue/integ Do
Staff and Manufacturers (blue book
memo #I93-1)
Clinical Utility and Premarket May 3, 1991 ODE/blue/pma Do
Approval (blue book memo #P91-1)
Criteria for Panel Review of PMA January 30, 1986 ODE/blue/pma Do
Supplements (blue book memo #P86-3)
Panel Report and Recommendations on April 18, 1986 ODE/blue/pma Do
PMA Approvals (blue book memo #P86-5)
Panel Review of 'Me-Too' Devices July 1, 1986 ODE/blue/pma Do
(blue book memo #P86-6)
Panel Review of Premarket Approval May 3, 1991 ODE/blue/pma Do
Applications (blue book memo #P91-2)
PMA Compliance Program (blue book memo May 3, 1991 ODE/blue/pma Do
#P91-3)
PMA Filing Decisions (blue book memo May 18, 1990 ODE/blue/pma Do
#P90-2)
PMA Refuse to File Procedures (blue May 20, 1994 ODE/blue/pma Do
book memo #P94-1)
PMA Supplements: ODE's letter to April 24, 1990 ODE/blue/pma Do
manufacturers; identifies situations
which may require the submission of a
PMA supplement (when PMA Supplements
are required) (blue book memo) #P90-1
PMAs Early Review and Preparation of January 27, 1986 ODE/blue/pma Do
Summaries of Safety and Effectiveness
(blue book memo #P86-1)
Premarket Approval Application (PMA) July 8, 1994 ODE/blue/pma Do
Closure (blue book memo #P94-1)
[[Page 31246]]
Review and Approval of PMAs of October 22, 1990 ODE/blue/pma Do
Licensees (blue book memo #P86-4)
Review of Final Draft Medical Device August 29, 1991 ODE/blue/pma Do
Labeling (blue book memo #P91-4)
Distribution and Public Availability October 10, 1997 ODE/blue/pma Do
of Premarket Approval Application
Summary of Safety and Effectiveness
Data Packages (P98-1)
PMA Summaries of Safety and June 11, 1993 ODE/blue/pma Do
Effectiveness and Federal Register
Notices of PMA Approvals--Review by
the Office of General Counsel
(Revised) (P98-1)
PMA Review Schedules (P87-1) March 31, 1988 ODE/blue/pma Do
Points to Consider Guidance Document February 3, 1999 ODE/Division of Do
on Assayed and Unassayed Quality Clinical Laboratory
Control Material Devices (DCLD)
Review Criteria for Assessment of October 30, 1996 ODE/DCLD Do
Antimicrobial Susceptibility Test
Discs
Guidance for Submission of June 3, 1998 ODE/DCLD Do
Immunohistochemistry Applications to
the FDA
In Vitro Diagnostic Creatinine Test July 2, 1998 ODE/DCLD Do
System
In Vitro Diagnostic Bicarbonate/Carbon July 6, 1998 ODE/DCLD Do
Dioxide Test System
In Vitro Diagnostic Chloride Test July 6, 1998 ODE/DCLD Do
System
In Vitro Diagnostic Glucose Test July 6, 1998 ODE/DCLD Do
System
In Vitro Diagnostic Potassium Test July 6, 1998 ODE/DCLD Do
System
In Vitro Diagnostic Sodium Test System July 6, 1998 ODE/DCLD Do
In Vitro Diagnostic Urea Nitrogen Test July 6, 1998 ODE/DCLD Do
System
In Vitro Diagnostic C-Reactive July 20, 1998 ODE/DCLD Do
Immunological Test System
In Vitro Diagnostic Calibrators July 20, 1998 ODE/DCLD Do
Points To Consider For Hematology September 30, 1997 ODE/DCLD Do
Quality Control Materials
Guidance for Premarket Submissions for December 30, 1998 ODE/DCLD Do
Kits for Screening Drugs of Abuse to
be Used by the Consumer
Review Criteria for Assessment of November 6, 1996 ODE/DCLD Do
Professional Use Human Chorionic
Gonadotropin (hCG) in Vitro
Diagnostic Devices (IVDs)
Letter to IVD Manufacturers on December 22, 1997 ODE/DCLD Do
Streamlined PMA
Guidance Document for the Submission September 19, 1996 ODE/DCLD Do
of Tumor Associated Antigen Premarket
Notification [510(k)] to FDA
Review Criteria for Assessment of February 21, 1997 ODE/DCLD Do
Rheumatoid Factor (RF) In Vitro
Diagnostic Devices Using Enzyme-
Linked Immunoassay (EIA), Enzyme
Linked Immunosorbent Assay (ELISA),
Particle Agglutination Tests, and
Laser and Rate Nephgelometry
Guidance for 510(k)s on Cholesterol July 14, 1995 ODE/DCLD Do
Tests for Clinical Laboratory,
Physicians' Office Laboratory, and
Home Use
Assessing the Safety/Effectiveness of October 1, 1988 ODE/DCLD Do
Home-use In Vitro Diagnostic Devices
(IVDs): Draft Points to Consider
Regarding Labeling and Premarket
Submissions
Data for Commercialization of Original June 10, 1996 ODE/DCLD Do
Equipment Manufacturer, Secondary and
Generic Reagents for Automated
Analyzers
DCLD Tier/Triage lists (include 931) May 31, 1996 ODE/DCLD Do
Draft Criteria for Assessment of In August 31, 1995 ODE/DCLD Do
Vitro Diagnostic Devices for Drugs of
Abuse Assays Using Various
Methodologies
Draft Guidance Document for 510(k) July 29, 1992 ODE/DCLD Do
Submission of Fecal Occult Blood
Tests
Draft Guidance Document for 510(k) September 30, 1991 ODE/DCLD Do
Submission of Glycohemoglobin
(Glycated or Glycosylated) Hemoglobin
for IVDs
Draft Guidance Document for 510(k) September 1, 1992 ODE/DCLD Do
Submission of Immunoglobulins A, G,
M, D and E Immunoglobulin System In
Vitro Devices
[[Page 31247]]
Draft Guidance for 510(k) Submission September 26, 1991 ODE/DCLD Do
of Lymphocyte Immunophenotyping IVDs
using Monoclonal Antibodies
Draft Review Criteria for Nucleic Acid June 14, 1993 ODE/DCLD Do
Amplification Based In Vitro
Diagnostic Devices for Direct
Detection of Infectious
Microorganisms
Guidance Criteria for Cyclosporine January 24, 1992 ODE/DCLD Do
PMAs
Draft: Premarketing Approval Review September 10, 1992 ODE/DCLD Do
Criteria for Premarket Approval of
Estrogen (ER) or Progesterone (PGR)
Receptors In Vitro Diagnostic Devices
Using Steroid Hormone
Points to Consider for Cervical July 25, 1994 ODE/DCLD Do
Cytology Devices
Points to Consider for Collection of September 26, 1994 ODE/DCLD Do
Data in Support of In-Vitro Device
Submissions for 510(k) Clearance
Points to Consider for Portable Blood February 20, 1996 ODE/DCLD Do
Glucose Monitoring Devices Intended
for Bedside Use in the Neonate
Nursery
Points to Consider for Review of February 1, 1996 ODE/DCLD 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 ODE/DCLD Do
Diagnostic Devices for the Assessment
of Thyroid Autoantibodies Using
Indirect Immunofluorescence Assay
(IFA), Indirect Hemagglutination
Assay (IHA), Radioimmunoasay (RIA),
and Enzyme Linked Immunosorbent Assay
(ELISA)
Review Criteria for Assessment of July 15, 1994 ODE/DCLD 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 ODE/DCLD Do
Antimicrobial Susceptibility Devices
Review Criteria for Assessment of July 15, 1991 ODE/DCLD Do
Cytogenetic Analysis Using Automated
and Semi-Automated Chromosome
Analyzers
Review Criteria for Assessment of September 27, 1995 ODE/DCLD Do
Human Chorionic Gonadotropin (hCG) In
Vitro Diagnostic Devices (IVDs)
Review Criteria for Assessment of In January 1, 1992 ODE/DCLD Do
Vitro Diagnostic Devices for Direct
Detection of Chlamydiae in Clinical
Specimens
Review Criteria for Assessment of In July 6, 1993 ODE/DCLD Do
Vitro Diagnostic Devices for Direct
Detection of Mycobacterium Spp.
(Tuberculosis (TB))
Review Criteria for Assessment of September 17, 1992 ODE/DCLD Do
Laboratory Tests for the Detection of
Antibodies to Helicobacter pylori
Review Criteria for Assessment of February 14, 1996 ODE/DCLD Do
Portable Blood Glucose In Vitro
Diagnostic Devices Using Glucose
Oxidase, Dehydrogenase, or Hexokinase
Methodology
Review Criteria for Blood Culture August 12, 1991 ODE/DCLD Do
Systems
Review Criteria for Devices Assisting May 31, 1990 ODE/DCLD Do
in the Diagnosis of C. Difficile
Associated Diseases
Review Criteria for Devices Intended December 30, 1991 ODE/DCLD Do
for the Detection of Hepatitis B 'e'
Antigen and Antibody to HBe
Review Criteria for In Vitro August 1, 1992 ODE/DCLD Do
Diagnostic Devices for Detection of
IGM Antibodies to Viral Agents
Review Criteria for In Vitro February 15, 1996 ODE/DCLD Do
Diagnostic Devices that Utilize
Cytogenetic In Situ Hybridization
Technology for the Detection of Human
Genetic Mutations (Germ Line and
Somatic)
Review Criteria For Premarket Approval May 15, 1992 ODE/DCLD Do
of In Vitro Diagnostic Devices for
Detection of Antibodies to Parvovirus
B19
Review Criteria for the Assessment of March 2, 1993 ODE/DCLD Do
Allergen-Specific Immunoglobulin E
(IGE) In-Vitro Diagnostic Devices
Using Immunological Test
Methodologies
[[Page 31248]]
Review Criteria for the Assessment of September 1, 1992 ODE/DCLD Do
Anti-nuclear Antibodies (ANA) In-
Vitro Diagnostic Devices Using
Indirect Immunofluorescence Assay
(IFA), Immunodiffusion (IMD) and
Enzyme Linked Immunosorbant Assay
(ELISA)
Non-Automated Sphygmomanometer (Blood November 19, 1998 ODE/DCRND Do
Pressure Cuff) Guidance
Cardiac Monitor Guidance (including November 5, 1998 ODE/Division of Do
Cardiotachometer and Rate Alarm) Cardiovascular,
Respiratory and
Neurological Devices
(DCRND)
Diagnostic ECG Guidance (Including Non- November 5, 1998 ODE/DCRND Do
Alarming ST Segment measurement)
Carotid Stent--Suggestions for Content October 26, 1996 ODE/DCRND 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 ODE/DCRND Do
Monitor Guidance
Guidance for Off-the-Shelf Software June 4, 1997 ODE/DCRND Do
Use in Medical Devices; Draft
Document
Draft Percutaneous Transluminal February 7, 1995 ODE/DCRND Do
Coronary Angioplasty Package Insert
Template
Medical Device Labeling--Suggested August 12, 1997 ODE/DCRND Do
Format and Content; Draft Document
Draft Intravascular Brachytherapy-- May 24, 1996 ODE/DCRND Do
Guidance for Data to be Submitted to
the Food and Drug Administration in
Support of Investigational Device
Exemption (IDE) Applications
510(k) Reviewer Guidelines-- January 1, 2000 ODE/DCRND Do
Tracheostomy Tubes 868.5800
Balloon Valvuloplasty Guidance For The January 1, 1989 ODE/DCRND Do
Submission Of an IDE Application and
a PMA Application
Rechargeable Battery Preliminary July 12, 1993 ODE/DCRND Do
Guidance for Data to be Submitted to
FDA in Support of Premarket
Notification Applications
Review Guidance for Anesthesia May 15, 1991 ODE/DCRND Do
Conduction Catheter
Coronary and Cerebrovascular Guidewire January 1, 1995 ODE/DCRND Do
Guidance
Draft Guidance: Human Heart Valve June 21, 1991 ODE/DCRND Do
Allografts
Draft Replacement Heart Valve Guidance October 14, 1994 ODE/DCRND Do
Draft Reviewer Guidance for July 1, 1995 ODE/DCRND Do
Ventilators
Draft Reviewer Guidance on Face Masks March 16, 1996 ODE/DCRND Do
and Shield for CPR
Draft Version Cardiac Ablation March 1, 1995 ODE/DCRND Do
Preliminary Guidance (Data to be
Submitted to FDA in Support
Investigation Device Exemption
Application
Draft Version Electrode Recording March 1, 1995 ODE/DCRND Do
Catheter Preliminary Guidance (Data
to be Submitted to FDA in Support of
Premarket Notifications
Excerpts Related to EMI from November November 1, 1993 ODE/DCRND Do
1993 Anesthesiology and Respiratory
Devices Branch (to be used with EMI
standard)
General Guidance Document: Non- September 7, 1992 ODE/DCRND Do
Invasive Pulse Oximeter
Guidance for Oxygen Conserving Device February 1, 1989 ODE/DCRND Do
510(k) Review 73 BZD 868.5905 Non-
continuous Ventilator Class II
Reviewer Guidance for Premarket July 19, 1995 ODE/DCRND Do
Notification (510(k)) Submissions--
Labeling, Performance and
Environmental Testing for Electronic
Devices
Guidance for Peak Flow Meters for Over- June 1, 1993 ODE/DCRND Do
the-Counter Sale
Guidance for the Preparation of the April 1, 1990 ODE/DCRND Do
Annual Report to the PMA Approved
Heart Valve Prostheses
Heated Humidifier Review Guidance August 30, 1991 ODE/DCRND Do
Implantable Pacemaker Lead Testing September 1, 1989 ODE/DCRND Do
Guidance For The Submission of a
Section 510(k) Notification
Implantable Pacemaker Testing Guidance January 12, 1990 ODE/DCRND Do
Policy for Expiration Dating (DCRND October 30, 1992 ODE/DCRND Do
RB92-G)
[[Page 31249]]
Review Guidelines for Oxygen Undated ODE/DCRND Do
Generators and Oxygen Equipment
Reviewer Guidance for Nebulizers, November 9, 1990 ODE/DCRND Do
Metered Dose Inhalers, Spacers and
Actuators
Reviewer's Guidance for Oxygen August 30, 1991 ODE/DCRND Do
Concentrator
Electrocardiograph (ECG) Electrode February 11, 1997 ODE/DCRND Do
Electrocardiograph (ECG) Lead February 11, 1997 ODE/DCRND Do
Switching Adapter
Electrocardiograph (ECG) Surface February 11, 1997 ODE/DCRND Do
Electrode Tester
Guidance on the Content of Premarket December 1, 1995 ODE/Division of Do
Notification [510(k)] Submissions for Dental Infection
Protective Restraints Control and General
Hospital Devices
(DDIGD)
Guidance for the Preparation of November 27, 1998 ODE/DDIGD Do
Premarket Notifications for Dental
Composites
Neonatal and Neonatal Transport September 18, 1998 ODE/DDIGD Do
Incubators Premarket Notifications
Reexamination of the Evaluation May 19, 1997 ODE/DDIGD Do
Process for Liquid Chemical Sterilant
and High Level Disinfectants
Further Information on the Regulation August 5, 1997 ODE/DDIGD Do
of Liquid Chemical Sterilants and
High Level Disinfectants
Guidance on the Content and Format of December 18, 1997 ODE/DDIGD Do
Premarket Notifications [510(k)]
Submissions for Liquid Chemical
Sterilants and High Level
Disinfectants
Guidance on the Content and Format of January 16, 1998 ODE/DDIGD Do
Premarket Notification [510(k)]
Submissions for Surgical Masks
Premarket Notification [510(k)] January 13, 1999 ODE/DDIGD Do
Submissions for Testing for Skin
Sensitization to Chemicals in Natural
Rubber Products (Replaces: Guidance
on the Content and Format of
Premarket Notifications [510(k)]
Submissions for Testing for Skin
Sensitization to Chemicals in Natural
Rubber Products--2/13/98)
Guidance on the Content and Format of August 4, 1998 ODE/DDIGD Do
Premarket Notification [510(k)]
Submissions of Washers and Washer-
Disinfectors
Devices for the Treatment and/or June 10, 1998 ODE/DDIGD Do
Diagnosis of Temporomandibular Joint
Dysfunction and/or Orofacial Pain
Dental Impression Materials--Premarket August 17, 1998 ODE/DDIGD Do
Notification
OTC Denture Cushions, Pads, Reliners, August 18, 1998 ODE/DDIGD Do
Repair Kits, and Partially Fabricated
Denture Kits
Dental Cements--Premarket Notification August 18, 1998 ODE/DDIGD Do
Groups Capable of Testing for Latex July 28, 1997 ODE/DDIGD Do
Skin Sensitization (Addendum to #944)
Addendum to: Guidance on Premarket September 19, 1995 ODE/DDIGD Do
Notification [510(k)] Submissions for
Sterilizers Intended for Use in
Health Care Facilities
Guidance Document on Dental Handpieces July 1, 1995 ODE/DDIGD/Dental Do
Devices Branch (DDB)
510(k) Guidance for Screw Type August 11, 1992 ODE/DDIGD/DDB Do
Endosseous Implants for Prosthetic
Attachment
510(k) Information Needed for July 6, 1993 ODE/DDIGD/DDB Do
Hydroxyapatite Coated Titanium
Endosseous Implants
510(k) Information Needed for August 12, 1993 ODE/DDIGD/DDB Do
Metallurgical Endosseous Implants
510(k) Information Needed for Ti- July 13, 1993 ODE/DDIGD/DDB Do
Powder Coated Titanium Endosseous
Implants
Draft Guidance Document for the March 3, 1997 ODE/DDIGD/DDB Do
Preparation of Premarket Notification
[510(k)'s] for Dental Alloys
Guidance Document for the Preparation January 23, 1995 ODE/DDIGD/DDB Do
of Premarket Notifications (510(k)'s)
for Temporomandibular Joint Implants
Guidance for the Arrangement and May 16, 1989 ODE/DDIGD/DDB Do
Content of a Premarket Approval (PMA)
Application For An Endosseous Implant
For Prosthetic Attachment
Guidance for the Preparation of January 1, 2000 ODE/DDIGD/DDB Do
Premarket Notification [510(k)] for
Resorbable Periodontal Barriers
[[Page 31250]]
Information Necessary for Premarket December 9, 1996 ODE/DDIGD/DDB Do
Notification Submissions for Screw-
Type Endossesous Implants
Outline of Recommended Procedures for January 1, 2000 ODE/DDIGD/DDB Do
a Clinical Investigation of
Endosseous Implants Under a 510(k)
Outline of Recommended Procedures for January 1, 2000 ODE/DDIGD/DDB Do
Animal Laboratory Studies of
Endosseous Implants
Guidance on the Content of Premarket April 1, 1993 ODE/DDIGD/General Do
Notification [510(k)] Submissions for Hospital Devices
Piston Syringes Branch (GHDB)
Draft Supplementary Guidance on the March 1, 1995 ODE/DDIGD/GHDB Do
Content of Premarket Notification
[510(k)] Submissions for Medical
Devices with Sharps Injury Prevention
Features (Antistick)
Guidance on 510(k) Submissions for October 1, 1990 ODE/DDIGD/GHDB Do
Implanted Infusion Ports
Guidance on Premarket Notification March 16, 1995 ODE/DDIGD/GHDB Do
[510(k)] Submissions for Short-Term
and Long-Term Intravascular Catheters
Guidance on the Content of Premarket March 1, 1993 ODE/DDIGD/GHDB Do
Notification [510(k)] Submissions for
Clinical Electronic Thermometers
Guidance on the Content of Premarket March 1, 1993 ODE/DDIGD/GHDB Do
Notification [510(k)] Submissions for
External Infusion Pumps
Guidance on the Content of Premarket April 1, 1993 ODE/DDIGD/GHDB Do
Notification [510(k)] Submissions for
Hypodermic Single Lumen Needles
Guidance on Premarket Notification August 1, 1993 ODE/DDIGD/Infection Do
[510(k)] Submissions for Automated Control Devices
Endoscope Washers, Washer/ Branch (ICDB)
Disinfectors, and Disinfectors
Intended for Use in Health Care
Facilities
Guidance on Premarket Notification August 1, 1993 ODE/DDIGD/ICDB Do
[510(k)] Submissions for Surgical
Gowns and Surgical Drapes
Guidance on the Content and Format of December 6, 1996 ODE/DDIG/ICDB Do
Premarket Notification 510(k)
Submissions for Liquid Chemical
Germicides
Guidance on the Content and Format of October 1, 1993 ODE/DDIGD/ICDB Do
Premarket Notification [510(k)]
Submissions for General Purpose
Disinfectants (and 3/9/94 Addendum)
Guidance on the Content and Format of October 1, 1993 ODE/DDIGD/ICDB Do
Premarket Notification [510(k)]
Submissions for Sharps Containers
Addendum to Guidance on the Content March 9, 1994 ODE/DDIGD/ICDB Do
and Format of Premarket Notification
[510(k)] Submissions for General
Purpose Disinfectants
Guidance on Premarket Notification March 3, 1993 ODE/Division of Do
510(k) for Sterilizers Intended for General and
Use in Health Care Facilities Restorative Devices
(DGRD)
Guidance Document for Powered Suction September 30, 1998 ODE/DGRD Do
Pump 510(k)s
Guidance Document for Industry and March 18, 1998 ODE/DGRD Do
CDRH Staff for the Preparation of
Investigational Device Exemptions and
Premarket Approval Applications for
Bone Growth Stimulator Devices
(Replaces: Guidance Document for the
Preparation of Investigatinal Device
Exemptions and Premarket Approval
Applications for Bone Growth
Stimulator Devices--8/12/88)
Guidance for Content of Premarket April 28, 1998 ODE/DGRD Do
Notifications for Esophageal and
Tracheal Prostheses
Guidance Document for Surgical Lamp July 13, 1998 ODE/DGRD Do
510ks
Protocol for Dermal Toxicity Testing January 1, 2000 ODE/DGRD Do
for Devices in Contact with Skin
(Draft)
Guide for 510(k) Review of Processed June 26, 1990 ODE/DGRD Do
Human Dura Mater
Guide for TENS 510(k) Content (Draft) August 1, 1994 ODE/DGRD Do
Guidelines for Reviewing Premarket January 1, 2000 ODE/DGRD Do
Notifications that Claim Substantial
Equivalence to Evoked Response
Stimulators
[[Page 31251]]
Guidance for Studies for Pain Therapy May 12, 1988 ODE/DGRD Do
Devices--General Considerations in
the Design of Clinical Studies for
Pain-Alleviating Devices
Galvanic Skin Response Measurement August 23, 1994 ODE/DGRD Do
Devices--Draft Guidance for 510(k)
Content
Draft Version Guide for Cortical August 10, 1992 ODE/DGRD Do
Electrode 510(k) Content
Draft Version Neuro Endoscope Guidance July 7, 1994 ODE/DGRD Do
Draft Version Guidance for Clinical August 20, 1992 ODE/DGRD Do
Data to be Submitted for Premarket
Approval Application for Cranial
Electrotherapy Stimulators
Draft Version 1--Biofeedback Devices-- August 1, 1994 ODE/DGRD Do
Draft Guidance for 510(k) Content
Draft Version--Guidance on September 12, 1994 ODE/DGRD Do
Biocompatibility Requirements for
Long Term Neurological Implants: Part
3--Implant Model
Draft Premarket Notification Review June 1, 1994 ODE/DGRD Do
Guidance for Evoked Response
Somatosensory Stimulators
Draft Version Cranial Perforator July 13, 1994 ODE/DGRD Do
Guidance
ORDB 510(k) Sterility Review Guidance July 3, 1997 ODE/DGRD Do
Draft Guidance for Testing MR May 22, 1996 ODE/DGRD Do
Interaction with Aneurysm Clips
Draft 510(k) Guideline for General May 10, 1995 ODE/DGRD/General Do
Surgical Electrosurgical Devices Surgery Devices
Brancch (GSDB)
Draft Guidance for Arthroscope and May 1994 ODE/DGRD/GSDB Do
Accessory 510(k)s
Guidance for the Preparation of a August 30, 1994 ODE/DGRD/GSDB Do
Premarket Notification for Extended
Laparoscopy Devices
Guidance on the Content and June 1, 1995 ODE/DGRD/GSDB Do
Organization of a Premarket
Notification for a Medical Laser
Guidance Document for Testing Bone April 20, 1996 ODE/DGRD/Orthopedic Do
Anchor Devices Devices Branch
(ORDB)
510(k) Information Needed for February 20, 1997 ODE/DGRD/ORDB Do
Hydroxyapatite Coated Orthopedic
Implants
Calcium Phosphate (Ca-P) Coating Draft February 21, 1997 ODE/DGRD/ORDB Do
Guidance for Preparation of FDA
Submissions for Orthopedic and Dental
Endosseous Implants
Draft Data Requirements for Ultrahigh March 28, 1995 ODE/DGRD/ORDB Do
Molecular Weight Polyethylene
(Uhmupe) Used in Orthopedic Devices
Draft Guidance Document for Femoral August 1, 1995 ODE/DGRD/ORDB Do
Stem Prostheses
Draft Guidance Document for Testing May 1, 1995 ODE/DGRD/ORDB Do
Acetabular Cup Prostheses
Draft Guidance Document for the July 16, 1997 ODE/DGRD/ORDB Do
Preparation of Premarket Notification
[510(k)] Applications for Orthopedic
Devices-The Basic Elements
Draft Guidance for the Preparation of April 1, 1993 ODE/DGRD/ORDB Do
Premarket Notifications [510(k)s] for
Cemented, Semi-Constrained Total Knee
Prostheses
Draft Guideline for Reviewing Spinal January 9, 1997 ODE/DGRD/ORDB Do
Fixation Device Systems
Draft of Guidance Document for Testing October 25, 1995 ODE/DGRD/ORDB 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 ODE/DGRD/ORDB Do
for Testing Orthopedic Bone Cement,
request for comments by December 10,
1993
Guidance Document for Testing April 20, 1996 ODE/DGRD/ORDB Do
Biodegradable Polymer Implant Devices
Guidance Document for Testing Non- May 1, 1995 ODE/DGRD/ORDB Do
Articulating, ``Mechanically
Locked'', Modular Implant Components
Guidance Document for Testing April 28, 1994 ODE/DGRD/ORDB Do
Orthopedic Implants with Modified
Metallic Surfaces Apposing Bone or
Bone Cement
[[Page 31252]]
Guidance Document for the Preparation February 18, 1993 ODE/DGRD/ORDB Do
of IDE and PMA Applications for Intra-
Articular Prosthetic Knee Ligament
Devices
Guidance Document for the Preparation January 10, 1995 ODE/DGRD/ORDB Do
of Premarket Notification for Ceramic
Ball Hip Systems
Reviewers Guidance Checklist for February 21, 1997 ODE/DGRD/ORDB Do
Intramedullary Rods
Reviewers Guidance Checklist for February 21, 1997 ODE/DGRD/ORDB Do
Orthopedic External Fixation Devices
Electroencephalograph Device Draft June 25, 1997 ODE/DGRD/Plastic and Do
Guidance for 510(k) Content Reconstructive
Surgery Devices
Branch (PRSB)
Alternate Suture Labeling Resulting January 11, 1993 ODE/DGRD/PRSB Do
from the January 11, 1993, Meeting
with HIMA
Copy of October 9, 1992 Letter and ODE/DGRD/PRSB Do
Original Suture Labeling Guidance
Draft Guidance for Preparation of PMA January 18, 1995 ODE/DGRD/PRSB Do
Applications for Silicone Inflatable
(Saline) Breast Prostheses
Draft Guidance for Preparations of FDA May 11, 1992 ODE/DGRD/PRSB Do
Submissions of Silicone Gel-Filled
Breast Prostheses
Draft Guidance for Testing of September 1, 1994 ODE/DGRD/PRSB Do
Alternative Breast Prostheses
(nonsilicone gel-filled)
Draft Guidance for the Preparation of March 31, 1995 ODE/DGRD/PRSB Do
a Premarket Notification for a Non-
Interactive Wound and Burn Dressing
[510(k)]
Draft Guidance for the Preparation of April 1, 1995 ODE/DGRD/PRSB Do
IDE Submission for Interactive Wound
and Burn Dressing
Letter: Core Study for Silicone Breast January 11, 1996 ODE/DGRD/PRSB Do
Implants
Electrical Muscle Stimulator (EMS) July 11, 1985 ODE/DGRD/Restorative Do
Labeling Indications, Devices Branch
Contraindications, Warnings, etc. (REDB)
Technological Reporting for Powered January 1, 1992 ODE/DGRD/REDB Do
Muscle Stimulator 510k Submissions
Guidance Document for the Preparation July 26, 1995 ODE/DGRD/REDB Do
of Notification (510(k)) Applications
for Therapeutic Massagers and
Vibrators
Guidance Document for the Preparation July 26, 1995 ODE/DGRD/REDB Do
of Premarket Notification [510(k)]
Applications for Beds
Guidance Document for the Preparation July 26, 1995 ODE/DGRD/REDB Do
of Premarket Notification [510(k)]
Applications for Communications
Systems (Powered and Non-Powered) and
Powered Environmental Control Systems
Guidance Document for the Preparation July 26, 1995 ODE/DGRD/REDB Do
of Premarket Notification [510(k)]
Applications for Electromyograph
Needle Electrodes
Guidance Document for the Preparation July 26, 1995 ODE/DGRD/REDB Do
of Premarket Notification [510(k)]
Applications for Exercise Equipment
Guidance Document for the Preparation July 26, 1995 ODE/DGRD/REDB Do
of Premarket Notification [510(k)]
Applications for Heating and Cooling
Devices
Guidance Document for the Preparation July 26, 1995 ODE/DGRD/REDB Do
of Premarket Notification [510(k)]
Applications for Immersion
Hyudrobaths
Guidance Document for the Preparation July 26, 1995 ODE/DGRD/REDB Do
of Premarket Notification [510(k)]
Applications for Powered Muscle
Stimulators, and Ultrasound Diathermy
and Muscle Stimulators
Guidance Document for the Preparation July 26, 1995 ODE/DGRD/REDB Do
of Premarket Notification [510(k)]
Applications for Powered Tables and
Multifunctional Physical Therapy
Tables
Guidance Document for the Preparation July 26, 1995 ODE/DGRD/REDB Do
of Premarket Notification [510(k)]
Applications for Submerged
(Underwater) Exercise Equipment
[[Page 31253]]
Guidance Document for the Preparation July 26, 1995 ODE/DGRD/REDB Do
of Premarket Notification [510k)]
Applications for Mechanical and
Powered Wheelchairs, and Motorized
Three-Wheeled Vehicles
Aqueous Shunts--510(k) Submissions November 16, 1998 ODE/Division of Do
Opthalmics Devices
(DOD)
Guidance for Industry--Guidance October 9, 1998 ODE/DOD Do
Document for Nonprescription
Sunglasses
Third Party Review Guidance for January 31, 1997 ODE/DOD Do
Vitreous Aspiration and Cutting
Device Premarket Notification (510k)
Dear Sponsor Letter Concerning the May 20, 1997 ODE/DOD Do
Revocation of 21 CFR Part 813 IOL IDE
Regulations
Retinoscope Guidance July 8, 1998 ODE/DOD Do
Opthalmoscope Guidance July 8, 1998 ODE/DOD Do
Slit Lamp Guidance July 8, 1998 ODE/DOD Do
Revised Procedures for Adding Lens August 11, 1998 ODE/DOD Do
Finishing Laboratories to Approved
Premarket Approval Applications for
Class III Rigid Gas Permeable Contact
Lens for Extended Wear
Announcement by Dr. Alpert at 7/26/96 August 26, 1996 ODE/DOD Do
Ophthalmic Panel Meeting Concerning
Manufacturers & Users of Lasers for
Refractive Surgery [excimer
Announcement: Information for September 22, 1997 ODE/DOD Do
Manufacturers & Users of Lasers for
Refractive Surgery [excimer]
Intraocular Lens (IOL) Guidance October 10, 1997 ODE/DOD Do
Document
FDA Guidelines for Multifocal May 29, 1997 ODE/DOD Do
Intraocular Lens IDE Studies and PMAs
Premarket Notification [510(k)] May 12, 1994 ODE/DOD Do
Guidance Document for Class II Daily
Wear Contact Lenses
Contact Lenses: The Better the Care April 1, 1991 ODE/DOD Do
the Safer the Wear--FDA Publication
No. (FDA) (91-4220)
An FDA Survey of U.S. Contact Lens July 1, 1987 ODE/DOD Do
Wearers (Carol L. Herman) Reprinted
from Contact Lens Spectrum
Facts for Consumers from the Federal April 1, 1986 ODE/DOD Do
Trade Commission--Eyeglasses
Important Information About Rophae August 20, 1992 ODE/DOD Do
Intraocular Lenses
Checklist of Information Usually October 10, 1996 ODE/DOD Do
Submitted in an Investigational
Device Exemption (IDE) Application
for Refractive Surgery Lasers
[excimer]
Ophthalmic Device Triage List March 19, 1998 ODE/DOD Do
Discussion Points for Expansion of the September 5, 1997 ODE/DOD Do
'Checklist of Information Usually
Submitted in an Investigational
Device Exemption (IDE) Application
for Refractive Surgery Lasers' Draft
Document
Letter to Manufacturers and Users of October 10, 1996 ODE/DOD Do
Lasers for Refractive Surgery
[excimer]
Owners Certification of Lasers as PMA September 26, 1996 ODE/DOD Do
Approved Devices [excimer]
Update on Excimer Lasers for May 20, 1996 ODE/DOD Do
Nearsightedness
Amendment 1: Premarket Notification June 28, 1994 ODE/DOD Do
[510(k)] Guidance Document for Class
II Daily Wear Contact Lenses
Certification Statement for the Impact February 3, 1995 ODE/DOD Do
Resistance Test
Premarket Notification 510(k) Guidance May 1, 1997 ODE/DOD Do
for Contact Lens Care Products
Eye Valve Implant (and all glaucoma November 16, 1995 ODE/DOD Do
drainage devices) manufacturers
letter from N. C. Brogdon
New FDA Recommendations & Results of May 30, 1989 ODE/DOD Do
Contact Lens Study (7-day letter)
Sunglass Letter including 510(k) October 8, 1996 ODE/DOD Do
format
Sunglass Package February 3, 1995 ODE/DOD Do
Guidance for Industry; Noise Claims in October 21, 1998 ODE/Division of Do
Hearing Aid Labeling Reproductive,
Abdominal, ENT, and
Radiological Devices
(DRAERD)
[[Page 31254]]
Guidance for the Submission of November 14, 1998 ODE/DRAERD Do
Premarket Notification for Magnetic
Resonance Diagnostic Devices
Guidance for the Content of Premarket November 30, 1998 ODE/DRAERD Do
Notifications for Intracorporeal
Lithotripters
Guidance for the Submission of November 20, 1998 ODE/DRAERD Do
Premarket Notifications for
Radionuclide Dose Calibrators
Guidance for the Submission of December 3, 1998 ODE/DRAERD Do
Premarket Notifications for Emission
Computed Tomography Devices and
Accessories (SPECT and PET) and
Nuclear Tomography Systems
Information for Manufacturers Seeking February 4, 1999 ODE/-DRAERD Do
Marketing Clearance of Digital
Mammography Systems
Harmonic Imaging with/without November 16, 1998 ODE/DRAERD Do
Contrast--Premarket Notification
Requirements
Guidance for the Content of Premarket February 5, 1998 ODE/DRAERD Do
Notifications for Metal Expandable
Biliary Stents
Guidance for the Submission of 510(k) February 11, 1997 ODE/DRAERD Do
Premarket Notifications for
Cardiovascular Intravascular Filters
Tympanostomy Tubes, Submission January 14, 1998 ODE/DRAERD Do
Guidance for a 510(k) Premarket
Notification
Letter to Manufacturers of September 5, 1996 ODE/DRAERD Do
Falloposcopes
Letter to Manufacturers of September 6, 1996 ODE/DRAERD Do
Prescription Home Monitors for Non-
Stress Tests
Latex Condoms for Men--Information for July 23, 1998 ODE/DRAERD Do
510(k) Premarket Notifications: Use
of Consensus Standards for
Abbreviated Submissions
Uniform Contraceptive Labeling July 23, 1998 ODE/DRAERD Do
Guidance to Industry and CDRH August 7, 1998 ODE/DRAERD Do
Reviewers--Guidance for the Content
of Premarket Notifications for
Conventional and Permeability
Hemodialyzers (Replaces: Guidelines
for Premarket Testing of New
Conventional Hemodialyers, High
Premeability Hemodialyzers and
Hemofilters)
Devices Used for In Vitro September 10, 1998 ODE/DRAERD Do
Fertilization and Related Assisted
Reproduction Procedures
Guidance for the Technical Content of April 1, 1990 ODE/DRAERD Do
a Premarket Approval (PMA)
Application for an Endolymphatic
Shunt Tube with Valve
Letter: Notice to Manufacturers of September 25, 1997 ODE/DRAERD Do
Bone Mineral Densitometers
Draft Guidance to Hearing Aid August 5, 1994 ODE/DRAERD/Ear, Nose, Do
Manufacturers for Substantiation of and Throat Devices
Claims Branch (ENTB)
Guidance for Submission of a 510(k) April 1, 1991 ODE/DRAERD/ENTB Do
Premarket Notification for an Air
Conduction Hearing Aid
Guidance For The Arrangement and May 1, 1990 ODE/DRAERD/ENTB 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 ODE/DRAERD/ENTB Do
Notification for Disposable, Sterile,
Ear, Nose and Throat Endoscope
Sheaths with Protective Barrier
Claims
Guideline for the Arrangement and May 1, 1990 ODE/DRAERD/ENTB Do
Content of a Premarket Approval (PMA)
Application for a Cochlear Implant in
Adults at Least 18 Years of Age
Draft Guidance for Hemodialyzer Reuse October 6, 1995 ODE/DRAERD/ Do
Labeling Gastroenterology and
Renal Devices Branch
(GRDB)
Draft Guidance for the Content of May 30, 1997 ODE/DRAERD/GRDB Do
Premarket Notifications for Water
Purification Components and Systems
for Hemodialysis
Condom Packet: 4/13/94 R. J. Rivera April 13, 1994 ODE/DRAERD/Obstetrics/ Do
Letter, Condom Guidance & 7 Tabs, Gynecology Devices
General Guidance for Modifying Condom Branch (OGDB)
Labeling to Include Shelf Life
[[Page 31255]]
Draft Guidance for the Content of July 29, 1991 ODE/DRAERD/OGDB Do
Premarket Notifications for Loop and
Rollerball Electrodes for GYN
Electrosurgical Excisions
Draft Guidance for the Content of May 25, 1995 ODE/DRAERD/OGDB Do
Premarket Notifications for Menstrual
Tampons
Draft Thermal Endometrial Ablation March 14, 1996 ODE/DRAERD/OGDB Do
Devices (Submission Guidance for an
IDE)
Guidance (`Guidelines') for Evaluation March 8, 1977 ODE/DRAERD/OGDB Do
of Fetal Clip Electrode
Guidance (`Guidelines') for Evaluation May 10, 1978 ODE/DRAERD/OGDB Do
of Hysteroscopic Sterilization
Devices
Guidance (`Guidelines') for Evaluation January 1, 2000 ODE/DRAERD/OGDB Do
of Laparoscopic Bipolar and Thermal
Coagulators (and Accessories)
Guidance (`Guidelines') for Evaluation November 22, 1977 ODE/DRAERD/OGDB Do
of Tubal Occlusion Devices
Guidelines for Evaluation of Non-Drug September 28, 1976 ODE/DRAERD/OGDB Do
IUDs
Hysteroscopes and Gynecology March 27, 1996 ODE/DRAERD/OGDB Do
Laparoscopes--Submission Guidance for
a 510(k) --includes 00192
Hysteroscopes and Laparoscopic August 1, 1995 ODE/DRAERD/OGDB Do
Insufflators: Submission Guidance for
a 510(k)
In-vivo Devices for the Detection of June 14, 1997 ODE/DRAERD/OGDB Do
Cervical Cancer and its Precursors:
Submission Guidance for an IDE Draft
Document
Intrapartum Continuous Monitors for June 14, 1997 ODE/DRAERD/OGDB Do
Fetal Oxygen Saturation and Fetal pH;
Submission Guidance for a PMA; Draft
Document
Premarket Testing Guidelines for November 20, 1992 ODE/DRAERD/OGDB Do
Falloposcopes
Premarket Testing Guidelines for April 4, 1990 ODE/DRAERD/OGDB Do
Female Barrier Contraceptive Devices
also Intended to Prevent Sexually
Transmitted Diseases
Premarket Testing Guidelines for Home March 31, 1993 ODE/DRAERD/OGDB Do
Uterine Activity Monitors
Information for a Latex Condom 510(k) March 1994 ODE/DRAERD/OGDB Do
Submission for Obstetrics-Gynecology
Branch (draft)
Testing Guidance for Male Condoms Made June 29, 1995 ODE/DRAERD/OGDB Do
from New Material (Non-Latex)
Draft Guidance for Review of Bone November 9, 1992 ODE/DRAERD/Radiology Do
Densitometer 510(k) Submissions Devices Branch (RDB)
Guidance for Content and Review of a August 2, 1988 ODE/DRAERD/RDB Do
Magnetic Resonance Diagnostic Device
510(k) Application and 10/11/95 MRI
Guidance Update for dB/dt
Guidance for Magnetic Resonance September 29, 1997 ODE/DRAERD/RDB Do
Diagnostic Devices--Criteria for
Significant Risk Investigations
Guidance for the Comment and Review of August 1, 1993 ODE/DRAERD/RDB 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 ODE/DRAERD/RDB Do
for Solid State X-ray Imaging Devices
Information for Manufacturers Seeking September 30, 1997 ODE/DRAERD/RDB Do
Marketing Clearance of Diagnostic
Ultrasound Systems and Transducers
Information for Manufacturers Seeking June 19, 1996 ODE/DRAERD/RDB Do
Marketing Clearance of Digital
Mammography Systems
Reviewer Guidance for Automatic X-Ray February 1, 1990 ODE/DRAERD/RDB Do
Film Processor 510(k)
Simplified 510(k) procedures for December 21, 1993 ODE/DRAERD/RDB Do
certain radiology devices: 12/21/93
letter from L. Yin, ODE/DRAERD, to
NEMA
510(k) Checklist for Sterile September 19, 1994 ODE/DRAERD/Urology Do
Lubricating Jelly Used With and Lithrotripsy
Transurethral Surgical Instruments Devices Branch
(ULDB)
Draft Guidance to Firms on Biliary August 2, 1990 ODE/DRAERD/ULDB Do
Lithotripsy Studies
CDRH Interim Regulatory Policy for September 10, 1997 ODE/DRAERD/ULDB Do
External Penile Rigidity Devices
Checklist for Mechanical Lithotripters November 1, 1994 ODE/DRAERD/ULDB Do
and Stone Dislodgers Used in
Gastroenterology and Urology
[[Page 31256]]
Draft--510(k) Checklist for November 23, 1994 ODE/DRAERD/ULDB Do
Conditioned Response Enuresis Alarms
Draft 510(k) Checklist for Condom February 23, 1995 ODE/DRAERD/ULDB Do
Catheters
Draft 510(k) Checklist for Endoscopic August 16, 1995 ODE/DRAERD/ULDB Do
Electrosurgical Unit (ESU) and
Accessories Used in Gastroenterology
and Urology
Draft 510(k) Checklist for Endoscopic June 22, 1995 ODE/DRAERD/ULDB Do
Light Sources Used in
Gastroenterology and Urology
Draft 510(k) Checklist for Non- June 6, 1995 ODE/DRAERD/ULDB Do
Implanted Electrical Stimulators Used
for the Treatment of Urinary
Incontinence
Draft 510(k) Checklist for Urological August 1, 1995 ODE/DRAERD/ULDB Do
Irrigation System and Tubing Set
Draft Guidance for Clinical November 11, 1994 ODE/DRAERD/ULDB Do
Investigations of Devices Used for
the Treatment of Benign Prostatic
Hyperplasia (BPH)
Draft Guidance for Information on February 5, 1992 ODE/DRAERD/ULDB Do
Clinical Safety and Effectiveness
Data for Extracorporeal Shock Wave
Lithotripsy of Upper Urinary Tract
(Renal Pelvis, Renal Calyx and Upper
Ureteral) Calculi
Draft Guidance for Preclinical and November 29, 1995 ODE/DRAERD/ULDB Do
Clinical Investigations of Urethral
Bulking Agents Used in the Treatment
of Urinary Incontinence
Draft Guidance for Preparation of PMA March 16, 1993 OD/DRAERD/ULDB Do
Applications for Penile Inflatable
Implants
Draft Guidance for Preparation of PMA March 16, 1993 ODE/DRAERD/ULDB Do
Applications for Testicular
Prostheses
Draft Guidance for Preparation of PMA May 1, 1995 ODE/DRAERD/ULDB Do
Applications for the Implanted
Mechanical/Hydraulic Urinary
Continence Device (Artificial Urinary
Sphincter)
Draft Guidance for the Clinical November 2, 1995 ODE/DRAERD/ULDB Do
Investigation of Urethral Stents
Draft Guidance for the Content of March 17, 1995 ODE/DRAERD/ULDB Do
Premarket Notifications for
Endoscopes Used in Gastroenterology
and Urology
Draft Guidance for the Content of May 30, 1995 ODE/DRAERD/ULDB Do
Premarket Notifications for Penile
Rigidity Implants
Draft Guidance for the Content of January 24, 1992 ODE/DRAERD/ULDB Do
Premarket Notifications for
Urological Balloon Dilatation
Catheters
Draft Guidance Outline--Points to November 30, 1993 ODE/DRAERD/ULDB Do
Consider for Clinical Studies for
Vasovasostomy Devices
Draft of Suggested Information for January 18, 1991 ODE/DRAERD/ULDB Do
Reporting Extracorporeal Shock Wave
Lithotripsy Device Shock Wave
Measurements
Guidance for the Content of Premarket February 10, 1993 ODE/DRAERD/ULDBDo
Notifications for Biopsy Devices Used
in Gastroenterology and Urology
Guidance for the Content of Premarket September 12, 1994 ODE/DRAERD/ULDB Do
Notifications for Conventional and
Antimicrobial Foley Catheters
Guidance for the Content of Premarket February 10, 1993 ODE/DRAERD/ULDB Do
Notifications for Ureteral Stents
Guidance for the Content of Premarket June 7, 1994 ODE/DRAERD/ULDB Do
Notifications for Urine Drainage Bags
Guidance for the Content of Premarket July 29, 1994 ODE/DRAERD/ULDB Do
Notifications for Urodynamic/
Uroflowmetry Systems
Guidance to Manufacturers on the January 1, 2000 ODE/DRAERD/ULDB Do
Development of Required Postapproval
Epidemiologic Study Protocols for
Testicular Implants
Center for Devices and Radiological June 30, 1993 ODE/IDE/blue/ Do
Health's Investigational Device
Exemption (IDE) Refuse to Accept
Policy
Center for Devices and Radiological June 30, 1993 ODE/510k/blue/ Do
Health's Premarket Notification
[510(k)] Refuse to Accept Policy--
(updated Checklist 3/14/95)
[[Page 31257]]
Guidance For Request and Issuance of October 21, 1998 Office of Health and Do
Interim Notice Letters for Industry Programs
Mammography Facilities Under the MQSA (OHIP)/Division of
Mammography Quality
and Radiation
Programs (DMQRP)
Continuing Education Credits for March 17, 1998 OHIP/DMQRP Do
Reading/ Writing Articles/Papers and
Presenting Courses/Lectures
Accidental Radioactive Contamination August 13, 1998 OHIP/DMQRP Do
of Human Food and Animal Feeds:
Recommendations for State and Local
Agencies
Additional Mammography Review Policy March 26, 1998 OHIP/DMQRP Do
Guidance For Review of Cases of March 26, 1998 OHIP/DMQRP Do
Possible Suspension or Revocation of
Mammography Facility Certificates
Under the Mammography Quality
Standards Act (42 U.S.C. 263(b))
Guidance for Review of Requests for March 26, 1998 OHIP/DMQRP Do
Reconsideration of Adverse Decisions
on Accreditation of Mammography
Facilities Under the Mammography
Quality Standards Act (42 U.S.C.
263(b))
Guidance for Submission of Requests March 26, 1998 OHIP/DMQRP Do
for Reconsideration of Adverse
Decisions on Accreditation of
Mammography Facilities Under the
Mammography Quality Standards Act, 42
U.S.C. 263(b)
Supplement to The Physician's April 9, 1998 OHIP/DMQRP Do
Continuing Experience Requirement
Requalification for Interpreting May 28, 1998 OHIP/DMQRP Do
Physician's Continuing Experience
MQSA Policy Statements in a Question June 2, 1998 OHIP/DMQRP Do
and Answer
Compliance Guidance: The Mammography August 27, 1998 OHIP/DMQRP Do
Quality Standards Act Final
Regulations
MQSA Policy Statements for the Interim August 6, 1998 OHIP/DMQRP Do
Regulations
Policy for Facilities Changing April 15, 1998 OHIP/DMQRP Do
Accreditation Bodies
Addendum to What a Mammography July 31, 1996 OHIP/DMQRP Do
Facility Should do to Prepare for an
MQSA Inspection
Handbook of Selected Tissue Doses for September 1, 1995 OHIP/DMQRP Do
Fluoroscopic and Cineangiographic
Examination of the Coronary Arteries
(in SI Units) FDA 95-8289, (Units of
milliray (mmmGy) tissue dose and gray
(Gy) air kerma)
What a Mammography Facility Should Do June 30, 1995 OHIP/DMQRP Do
to Prepare for an MQSA Inspection
Policy Notebook in a Q/A Format January 23, 1998 OHIP/DMQRP Do
(update to existing document)
Guidance for Staff, Industry, and October 30, 1998 OHIP/Division of Do
Third Parties Implementation of Third Small Manufacturer's
Party Programs Under the FDA Assistance (DSMA)
Modernization Act of 1997
Pages 39.html Exporting Medical June 30, 1998 OHIP/DSMA Do
Devices and 391.html Foreign Liaison
List
Guidance for Staff, Industry and Third January 6, 1999 OHIP/DSMA Do
Parties: Third Party Programs Under
the Sectoral Annex on Medical Devices
to the Agreement on Mutual
Recognition Between the United States
of America and the European Community
(MRA)
A Pocket Guide to Device GMP November 1, 1991 OHIP/DSMA Do
Inspections--Inspections of Medical
Device Manufacturers and GMP
Regulation Requirements
Medical Device Reporting for March 1997 OHIP/DSMA Do
Manufacturers
Regulatory Requirement for Devices for August 1, 1987 OHIP/DSMA Do
the Handicapped (FDA 87-4221)
Comparison Chart: 1996 Quality System January 1, 2000 OHIP/DSMA Do
Reg vs. 1978 Good Manufacturing
Practices Reg vs. ANSI/ISO/ASQC Q9001
and ISO/DI 13485:1996 (include 126)
Small Business Guide to FDA (FDA 96- January 1, 1996 OHIP/DSMA Do
1092)
Investigational Device Exemptions July 1, 1996 OHIP/DSMA Do
[IDE] Manual (FDA 96-4159)/DSMA
An Introduction to Medical Device January 1, 1992 OHIP/DSMA Do
Regulations (FDA 92-4222)
[[Page 31258]]
In Vitro Diagnostic Devices: Guidance January 1, 1997 OHIP/DSMA Do
for the Preparation of 510(k)
Submissions (supersedes FDA 87-4224)
Instructions for Completion of Medical July 1, 1997 OHIP/DSMA Do
Device Registration and Listing Forms
FDA 2891, 2891a and 2892
Additional Guidance for Testing September 1, 1993 OHIP/DSMA Do
Immunity to Radiated Electromagnetic
Fields--Infant Apnea Monitor Standard
Classification Names for Medical March 1, 1995 OHIP/DSMA Do
Devices and In Vitro Diagnostic
Products (FDA Pub No. 95-4246)
Labeling--Regulatory Requirements for September 1, 1989 OHIP/DSMA Do
Medical Devices (FDA 89-4203)
List of Current CDRH Addresses for July 30, 1996 OHIP/DSMA Do
Report Submission and Ordering of
CDRH Forms
Obtaining CDRH Guidance Documents May 13, 1998 OHIP/DSMA Do
Premarket Approval (PMA) Manual (FDA July 1, 1997 OHIP/DSMA Do
97-4214)
Premarket Notification: 510(k)-- August 1, 1995 OHIP/DSMA Do
Regulatory Requirements for Medical
Devices (FDA 95-4158)
Procedures for Laboratory Compliance May 1, 1986 OHIP/DSMA Do
Testing of Television Receivers--Part
of TV Packet
Regulation of Medical Devices May 1, 1996 OHIP/DSMA Do
Background Information for Foreign
Officials
MDR Documents Access Information May 10, 1996 OHIP/DSMA Do
MDR Documents Access Information for February 29, 1996 OHIP/DSMA Do
CDRH Electronic Docket (ED)
MDR Documents Access Information for February 29, 1996 OHIP/DSMA Do
CDRH Facts-On-Demand (FOD)
MDR Documents Access Information for May 8, 1996 OHIP/DSMA Do
Industry Organizations
MDR Documents Access Information for May 10, 1996 OHIP/DSMA Do
National Technical Information
Service (NTIS)
MDR Documents Access Information for February 29, 1996 OHIP/DSMA Do
World Wide Web (WWW)
Medical Device Quality Systems Manual: December 1, 1996 OHIP/DSMA Do
A Small Entity Compliance Guide
Overview of FDA Modernization Act of February 19, 1998 OHIP/DSMA Do
1997, Medical Device Provisions
Medical Device Appeals and Complaints-- February 1, 1998 OHIP/DSMA/Office of Do
Guidance on Dispute Resolutions the Center Director
(OCD)
Medical Device Reporting for User April 1996 OHIP/Division of Do
Facilities Device User Programs
and Systems Analysis
(DUPSA)
Human Factors Points to Consider for January 17, 1997 OHIP/DUPSA Do
IDE Devices
Human Factors Principles for Medical September 1, 1993 OHIP/DUPSA Do
Device Labeling
Write it Right August 1, 1993 OHIP/DUPSA Do
Do It By Design--An Introduction to December 1, 1996 OHIP/DUPSA Do
Human Factors in Medical Devices
FDA Modernization Act of 1997: February 6, 1998 OHIP/Regs Do
Guidance for the Device Industry on
Implementation of Highest Priority
Provisions: Availability
Statistical Aspects of Submissions to June 1, 1984 OSB/Division of Do
FDA: A Medical Device Perspective Biostatistics (DB)
(also includes as Appendix the
Article Observed Uses and Abuses of
Statistical Procedures in Medical
Device Submissions
Statistical Guidance for Clinical January 1, 1996 OSB/DB Do
Trials of Non Diagnostic Medical
Devices (Replaces Clincal Study
Guidance, formerly 891)
Amendment to Guidance on Discretionary March 30, 1994 OSB/Division of Do
Postmarket Surveillance on Pacemaker Postmarket
Leads Surveillance (DPS)
Guidance on Procedures to Determine February 19, 1998 OSB/DPS Do
Application of Postmarket
Surveillance Strategies
Guidance on Procedures for Review of February 19, 1998 OSB/DPS Do
Postmarket Surveillance Submissions
SMDA to FDAMA: Guidance on FDA's February 19, 1998 OSB/DPS Do
Transition Plan for Existing
Postmarket Surveillance
[[Page 31259]]
Proposed Draft Guidance to Sponsors October 7, 1994 OSB/DPS Do
Regarding Required Postmarket
Surveillance Studies of Plasma-
Sprayed Porous-Coated Hip Prostheses
Guidance to Sponsors on the June 9, 1993 OSB/DPS Do
Development of a Discretionary
Postmarket Surveillance Study for
Permanent Implantable Cardiac
Pacemaker Electrodes (Leads)
Medical Device Reporting for April 1996 OSB/Division of Do
Distributors Surveillance Systems
(DSS)
Medical Device Reporting: An Overview April 1996 OSB/DSS Do
MDR Internet List Server (listserv) August 29, 1996 OSB/DSS Do
Instruction Sheet
MEDWATCH FDA Form 3500A For Use By June 1, 1993 OSB/DSS Do
User Facilities, Distributors and
Manufacturers for Mandatory Reporting
Instructions for Completing FDA Form December 15, 1995 OSB/DSS Do
3500A with Coding Manual for Form
3500A (MEDWATCH)
MDR Policy/Guidance for Endosseus December 1992 OSB/DSS Do
Implant Devices
MDR Guidance--Blood Loss Policy December 1995 OSB/DSS Do
Summary Reporting Approval for Adverse July 31, 1997 OSB/DSS Do
Events
Common Problems: Baseline Reports and OSB/DSS Do
MedWatch Form 3500A (letter to
manufacturer--undated)
MDR Guidance Document: Remedial Action July 30, 1996 OSB/DSS Do
Exemption--E1996001
Variance from Manufacturer Report July 16, 1996 OSB/DSS Do
Number Format [MDR letter]
Instructions for Completing Form 3417: March 31, 1997 OSB/DSS Do
Medical Device Reporting Baseline
Report [MDR]
MDR Guidance Document No. 1--IOL-- August 7, 1996 OSB/DSS Do
E1996004
MDR Guidance Document No. 3-- August 9, 1996 OSB/DSS Do
Needlestick & Blood Exposure--
E1996003
MDR Reporting Guidance For Breast August 7, 1996 OSB/DSS Do
Implants--E1996002
Instructions for Completing Semi- September 24, 1996 OSB/DSS Do
Annual Report, Form 3419 (MDR)
Guidance on FDA's Expectations of May 15, 1998 Office of Standards Do
Medical Device Manufacturers and Technology (OST)/
Concerning the Year 2000 Date Division of
Electronics and
Computer Science
(DECS)
Draft Document--A Primer on Medical February 7, 1997 OST/Division of Do
Device Interactions with Magnetic Postmarket
Resonance Imaging Systems Surveillance (DPS)
Frequently Asked Questions on February 19, 1998 OST/OD Do
Recognition of Consensus Standards
Guidance on the Recognition and Use of February 19, 1998 OST/OD Do
Consensus Standards
----------------------------------------------------------------------------------------------------------------
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)
----------------------------------------------------------------------------------------------------------------
Aerosol Steroid Product Safety January 12, 1998 Advertising Drug Information Branch (HFD-
Information in Prescription Drug 210), CDER, Food and Drug
Advertising and Promotional Labeling Administration, 5600 Fishers
Lane, Rockville, MD 20857,
301-827-4573, or via
Internet at http://
www.fda.gov/cder/guidance/
index.htm
Dissemination of Reprints of Certain October 8, 1996 Do Do
Published, Original Data
Funded Dissemination of Reference October 8, 1996 Do Do
Texts
[[Page 31260]]
Consumer-Directed Broadcast August 12, 1997 Advertising draft Do
Advertisements
Promoting Medical Products in a January 5, 1998 Do Do
Changing Healthcare Environment;
Medical Product Promotion by
Healthcare Organizations or Pharmacy
Benefits Management Companies (PBMs)
Alprazolam Tablets In Vivo November 27, 1992 Biopharmaceutic Do
Bioequivalence and In Vitro
Dissolution Testing
Bioavailability Policies and Do Do
Guidelines
Bumetanide Tablets In Vivo April 23, 1993 Do Do
Bioequivalence and In Vitro
Dissolution Testing
Buspirone Hydrochloride Tablets In May 15, 1998 Do Do
Vivo Bioequivalence and In Vitro
Dissolution Testing
Captopril Tablets In Vivo May 13, 1993 Do Do
Bioequivalence and In Vitro
Dissolution Testing
Carbidopa and Levodopa Tablets In Vivo June 19, 1992 Do Do
Bioequivalence and In Vitro
Dissolution Testing
Cefactor Capsules and Suspension In April 23, 1993 Do Do
Vivo Bioequivalence and In Vitro
Dissolution Testing
Cholestyramine Powder In Vitro July 15, 1993 Do Do
Bioequivalence
Cimetidine Tablets In Vivo June 12, 1992 Do Do
Bioequivalence and In Vitro
Dissolution Testing
Clozapine (Tablets) In Vivo November 15, 1996 Do Do
Bioequivalence and In Vitro
Dissolution Testing
Corticosteroids, Dermatologic June 2, 1995 Do Do
(topical) In Vivo
Diclofenac Sodium (tablets) In Vivo October 6, 1994 Do Do
Bioequivalence and In Vitro
Dissolution Testing
Diflunisal Tablets In Vivo May 16, 1992 Do Do
Bioequivalence and In Vitro
Dissolution Testing
Diltiazen Hydrochloride Tablets In May 16, 1992 Do Do
Vivo Bioequivalence and In Vitro
Dissolution Testing
Dissolution Testing of Immediate August 25, 1997 Do Do
Release Solid Oral Dosage Forms
Extended Release Oral Dosage Forms: September 26, 1997 Do Do
Development, Evaluation, and
Application of In Vitro/In Vivo
Correlations
Flurbiprofen (tablets) In Vivo June 8, 1995 Do Do
Bioequivalence and In Vitro
Dissolution Testing
Gemfibrozil Capsules or Tablets In June 15, 1992 Do Do
Vivo Bioequivalence and In Vitro
Dissolution Testing
Glipizide (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
Hydroxchloroquine Sulfate (tablets) In December 28, 1995 Do Do
Vivo Bioequivalence and In Vitro
Dissolution Testing
Indapamide (tablets) In Vivo April 23, 1993 Do Do
Bioequivalence and In Vitro
Dissolution Testing
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
Medroxyprogesterone Acetate (tablets) September 17, 1987 Do Do
In Vivo Bioequivalence and In Vitro
Dissolution Testing
Metaproferenol Sulfate and Albuterol June 27, 1989 Do Do
Metered Dose Inhalers In Vitro
Metoprolol Tartrate (tablets) In Vivo June 12, 1992 Do Do
Bioequivalence and In Vitro
Dissolution Testing
Nadolol (tablets) In Vivo May 16, 1992 Do Do
Bioequivalence and In Vitro
Dissolution Testing
Naproxen (tablets) In Vivo June 8, 1995 Do Do
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 Do
Vivo Bioequivalence and In Vitro
Dissolution Testing
Pentoxifyline (extended-release December 22, 1995 Do Do
tablets) In Vivo Bioequivalence and
In Vitro Dissolution Testing
Phenytoin/Phenytoin Sodium (capsules, March 4, 1994 Do Do
tablets, suspension) In Vivo
Bioequivalence and In Vitro
Dissolution Testing
[[Page 31261]]
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 June 6, 1994 Do Do
tablets and capsules) In Vivo
Bioequivalence and In Vitro
Dissolution Testing
Rantidine Hydrochloride (tablets) In April 23, 1993 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
Statistical Procedure for July 1, 1992 Do Do
Bioequivalence Studies Using a
Standard Two-Treatment Crossover
Design
Trazodone Hydrochloride (tablets) In April 30, 1988 Do Do
Vivo Bioequivalence and In Vitro
Dissolution Testing
Antifungal (topical) February 24, 1990 Biopharmaceutic draft Do
Antifungal (vaginal) February 24, 1990 Do Do
Bioanalytical Methods Validations for January 5, 1999 Do Do
Human Studies
Food-Effect Bioavailability and December 30, 1997 Do Do
Bioequivalence Studies
In Vivo Bioequivalence Studies Based December 30, 1997 Do Do
on Population and Individual
Bioequivalence Approaches
Topical Dermatological Drug Product June 18, 1998 Do Do
NDAs and ANDAs--In Vivo
Bioavailability, Bioequivalence, In
Vitro Release and Associated Studies
Waiver Policy March 29, 1993 Do Do
Glyburide Tablets In Vivo April 23, 1993 Biopharmaceutic Do
Bioequivalence and In Vitro testing
Dissolution Testing
Drug Master Files September 1, 1989 Chemistry Do
Environmental Assessment of Human July 27, 1998 Do Do
Drugs and Biologics Applications
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
Format and Content of the Chemistry, February 1, 1987 Do Do
Manufacturing and Controls Section of
an Application
Format and Content of the Microbiology February 1, 1987 Do Do
Section of an Application
PAC-ALTS: Postapproval Changes-- April 28, 1998 Do Do
Analytical Testing Laboratory Sites
Reviewer Guidance: Validation of November 1, 1994 Do Do
Chromatographic Methods
Submission of Chemistry, Manufacturing November 1, 1994 Do Do
and Controls Information for
Synthetic Peptide Substances
Submission of Documentation for November 1, 1994 Do Do
Sterilization Process Validation
Applications for Human and Veterinary
Drug Products
Submitting Documentation for Packaging February 1, 1987 Do Do
for Human Drugs and Biologics
Submitting Documentation for the February 1, 1987 Do Do
Manufacturing of and Controls for
Drug Products
Submitting Documentation for the February 1, 1987 Do Do
Stability of Human Drugs and
Biologics
Submitting Supporting Documentation in February 1, 1987 Do Do
Testing Drug Applications for the
Manufacture of Drug Substances
Submitting Samples and Analytical Data February 1, 1987 Do Do
for Methods Validation
SUPAC-IR--Immediate-Release Solid Oral November 30, 1995 Do Do
Dosage Forms: Scale-Up and Post-
Approval Changes: Chemistry,
Manufacturing and Controls, In Vitro
Dissolution Testing and In Vivo
Bioequivalence Documentation
SUPAC-IR: Immediate Release Solid Oral October 21, 1997 Do Do
Dosage Forms; Manufacturing Equipment
Addendum
SUPAC-IR Questions and Answers February 18, 1997 Do Do
[[Page 31262]]
SUPAC-MR: Modified Release Solid Oral October 6, 1997 Do Do
Dosage Forms: Scale-Up and
Postapproval Changes: Chemistry,
Manufacturing, and Controls, In Vitro
Dissolution Testing, and In Vivo
Bioequivalence Documentation
SUPAC-SS--Nonsterile Semisolid Dosage June 13, 1997 Do Do
Forms; Scale-Up and Postapproval
Changes: Chemistry, Manufacturing,
and Controls; In Vitro Release
Testing and In Vivo Bioequivalence
Documentation
BACPAC I: Intermediates in Drug November 30, 1998 Chemistry draft Do
Substance Synthesis (Bulk Actives
Postapproval Changes: Chemistry,
Manufacturing, and Controls
Documentation)
Content and Format of Investigational December 10, 1997 Do Do
New Drug Applications (INDs) for
Phases 2 and 3 Studies of Drugs,
Including Specific Therapeutic
Biotechnology-Derived Products--
Preliminary Draft
Metered Dose Inhalers (MDI) and Dry November 19, 1998 Do Do
Powder Inhalers (DPI) Drug Products;
Chemistry, Manufacturing, and
Controls Documentation
NDAs: Impurities in Drug Substances January 21, 1999 Do Do
Stability Testing of Drug Substances June 8, 1998 Do Do
and Drug Products
Submission of Documentation in Drug July 15, 1997 Do Do
Applications for Container Closure
Systems Used for the Packaging of
Human Drugs and Biologics
Submitting Supporting Chemistry November 1, 1991 Do Do
Documentation in Radiopharmaceutical
Drug Applications
SUPAC-IR/MR: Immediate Release and April 28, 1998 Do Do
Modified Release Solid Oral Dosage
Forms, Manufacturing Equipment
Addendum
SUPAC-SS: Nonsterile Semisolid Dosage January 5, 1999 Do Do
Forms
Tracking of NDA and ANDA Do Do
Reformulations for Solid, Oral,
Immediate Release Drug Products
Acute Bacterial Exacerbation of July 22, 1998 Clinical Do
Chronic Bronchitis; Developing antimicrobial draft
Antimicrobial Drugs for Treatment
Acute Bacterial Meningitis; Developing July 22, 1998 Do Do
Antimicrobial Drugs for Treatment
Acute Bacterial Sinusitis; Developing July 22, 1998 Do Do
Antimicrobial Drugs for Treatment
Acute or Chronic Bacterial July 22, 1998 Do Do
Prostatitis; Developing Antimicrobial
Drugs for Treatment
Acute Otitis Media; Developing July 22, 1998 Do Do
Antimicrobial Drugs for Treatment
Bacterial Vaginosis; Developing July 22, 1998 Do Do
Antimicrobial Drugs for Treatment
Community Acquired Pneumonia; July 22, 1998 Do Do
Developing Antimicrobial Drugs for
Treatment
Complicated Urinary Tract Infections July 22, 1998 Do Do
and Pylonephritis; Developing
Antimicrobial Drugs for Treatment
Empiric Therapy of Febrile July 22, 1998 Do Do
Neutropenia; Developing Antimicrobial
Drugs for Treatment
General Considerations for Clinical July 22, 1998 Do Do
Trials; Developing Antimicrobial
Drugs for Treatment
Lyme Disease; Developing Antimicrobial July 22, 1998 Do Do
Drugs for Treatment
Nosocomial Pneumonia; Developing July 22, 1998 Do Do
Antimicrobial Drugs for Treatment
Secondary Bacterial Infections of July 22, 1998 Do Do
Acute Bronchitis; Developing
Antimicrobial Drugs for Treatment
Streptococcal Pharyngitis and July 22, 1998 Do Do
Tonsillitis; Developing Antimicrobial
Drugs for Treatment
Uncomplicated Gonorrhea--Cervical, July 22, 1998 Do Do
Urethral, Rectal, and/or Pharyngeal;
Developing Antimicrobial Drugs for
Treatment
Uncomplicated Urinary Tract July 22, 1998 Do Do
Infections; Developing Antimicrobial
Drugs for Treatment
[[Page 31263]]
Uncomplicated and Complicated Skin and July 22, 1998 Do Do
Skin Structure Infections; Developing
Antimicrobial Drugs for Treatment
Vuvlovaginal Candidiasis; Developing July 22, 1998 Do Do
Antimicrobial Drugs for Treatment
Clinical Evaluation of Antidepressant September 1, 1977 Clinical medical Do
Drugs
Clinical Evaluation of Antidiarrheal September 1, 1977 Do Do
Drugs
Clinical Evaluation of Antiepileptic January 1, 1981 Do Do
Drugs (adults and children)
Clinical Evaluation of Combination March 20, 1995 Do Do
Estrogen/Progestin-Containing Drug
Products Used for Hormone Replacement
Therapy of Postmenopausal Women
Clinical Evaluation of October 1, 1981 Do Do
Radiopharmaceutical Drugs
Clinical Evaluation of Analgesic Drugs December 1, 1992 Do Do
Clinical Evaluation of Antacid Drugs April 1, 1978 Do Do
Clinical Evaluation of Anti- April 1, 1988 Do Do
Inflammatory and Antirheumatic Drugs
(adults and children)
Clinical Evaluation of Anti-Anxiety September 1, 1977 Do Do
Drugs
Clinical Evaluation of Anti-Infective September 1, 1977 Do Do
Drugs (Systemic)
Clinical Evaluation of Drugs to November 1, 1978 Do Do
Prevent, Control and/or Treat
Periodontal Disease
Clinical Evaluation of Gastric September 1, 1977 Do Do
Secretory Depressant (GSD) Drugs
Clinical Evaluation of General May 1, 1982 Do Do
Anesthetics
Clinical Evaluation of Hypnotic Drugs September 1, 1977 Do Do
Clinical Evaluation of Laxative Drugs April 1, 1978 Do Do
Clinical Evaluation of Local May 1, 1982 Do Do
Anesthetics
Clinical Evaluation of Psychoactive July 1, 1979 Do Do
Drugs in Infants and Children
Content and Format for Pediatric Use May 24, 1996 Do Do
Supplements
Content and Format of Investigational November 20, 1995 Do Do
New Drug Applications (INDs) for
Phase 1 Studies of Drugs, Including
Well-Characterized, Therapeutic,
Biotechnology-Derived Products
Development of Vaginal Contraceptive April 19, 1995 Do Do
Drugs (NDA)
FDA Approval of New Cancer Treatment February 2, 1999 Do Do
Uses for Marketed Drug and Biological
Products
FDA Requirements for Approval of Drugs June 20, 1989 Do Do
to Treat Superficial Bladder Cancer
FDA Requirements for Approval of Drugs January 29, 1991 Do Do
to Treat Non-Small Cell Lung Cancer
Format and Content of the Clinical and July 1, 1988 Do Do
Statistical Sections of an
Application
Format and Content of the Summary for February 1, 1987 Do Do
New Drug and Antibiotic Applications
Formatting, Assembling and Submitting February 1, 1987 Do Do
New Drug and Antibiotic Applications
General Considerations for the September 1, 1977 Do Do
Clinical Evaluation of Drugs in
Infants and Children
General Considerations for the December 1, 1978 Do Do
Clinical Evaluation of Drugs
Oncologic Drugs Advisory Committee April 13, 1988 Do Do
Discussion on FDA Requirements for
Approval of New Drugs for Treatment
of Ovarian Cancer
Oncologic Drugs Advisory Committee April 19, 1988 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 Do
Points to Consider: Clinical September 19, 1994 Do Do
Development Programs for MDI and DPI
Drug Products
Points to Consider in the Clinical October 26, 1992 Do Do
Development and Labeling of Anti-
Infective Drug Products
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 in the Preclinical November 1, 1990 Do Do
Development of Antiviral Drugs
[[Page 31264]]
Postmarketing Adverse Experience August 27, 1997 Do Do
Reporting for Human Drugs and
Licensed Biological Products;
Clarification of What to Report
Postmarketing Reporting of Adverse March 1, 1992 Do Do
Drug Experiences
Preparation of Investigational New November 1, 1992 Do Do
Drug Products (Human and Animal)
Providing Clinical Evidence of May 15, 1998 Do Do
Effectiveness for Human Drug and
Biological Products
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
Abuse Liability Assessment July 1, 1990 Clinical medical Do
draft
Clinical Development Programs for February 18, 1998 Do Do
Drugs, Devices, and Biological
Products Intended for the Treatment
of Osteoarthritis (OA)
Clinical Development Programs for March 18, 1998 Do Do
Drugs, Devices, and Biological
Products for the Treatment of
Rheumatoid Arthritis (RA)
Clinical Evaluation of May 1, 1988 Do Do
Antihypertensive Drugs
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 Drugs for the December 1, 1987 Do Do
Treatment of Congestive Heart Failure
Clinical Evaluation of Drugs for Do Do
Ulcerative Colitis (3rd draft)
Clinical Evaluation of Lipid-Altering September 1, 1990 Do Do
Agents in Adults and Children
Clinical Evaluation of Motility- Do Do
Modifying Drugs
Clinical Evaluation of Weight-Control October 1, 1997 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
Developing Medical Imaging Drugs and October 13, 1998 Do Do
Biologics
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 Do
Antimicrobials in the Division of
Anti-Infective Drug Products
Points to Consider for System Do Do
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
Preclinical and Clinical Evaluation of April 1, 1994 Do Do
Agents Used in the Prevention or
Treatment of Postmenopausal
Osteoporosis
Submission of Abbreviated Reports and September 21, 1998 Do Do
Synopses in Support of Marketing
Applications
Drug Metabolism/Drug Interaction April 7, 1997 Clinical pharmacology Do
Studies in the Drug Development
Process: Studies In Vitro
Format and Content of the Human February 1, 1987 Do Do
Pharmacokinetics and Bioavailability
Section of an Application
Pharmacokinetics and Pharmacodynamics May 15, 1998 Do Do
in Patients with Impaired Renal
Function: Study Design, Data
Analysis, and Impact on Dosing and
Labeling
Population Pharmacokinetics February 10, 1999 Do Do
General Considerations for Pediatric November 30, 1998 Clinical pharmacology o
Pharmacokinetic Studies for Drugs and draft
Biological Products
In Vivo Metabolism/Drug Interaction November 19, 1998 Do Do
Studies--Study Design, Data Analysis,
and Recommendations for Dosing and
Labeling
A Review of FDA's Implementation of Compliance Do
the Drug Export Amendments of 1986
Compressed Medical Gases December 1, 1989 Do Do
Expiration Dating and Stability June 27, 1997 Do Do
Testing of Solid Oral Dosage Form
Drugs Containing Iron
General Principles of Process May 1, 1987 Do Do
Validation
[[Page 31265]]
Good Laboratory Practice Regulations Do Do
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
Computerized Systems Used in Clinical June 18, 1997 Compliance draft Do
Trials
Investigating Out of Specification September 30, 1998 Do Do
(OOS) Test Results for Pharmaceutical
Production
Manufacture, Processing or Holding of April 17, 1998 Do Do
Active Pharmaceutical Ingredients
Repackaging of Solid Oral Dosage Form February 1, 1992 Do Do
Drug Products
ANDAs: Impurities in Drug Products January 5, 1999 Generic drug draft Do
ANDAs: Impurities in Drug Substances July 24, 1998 Do Do
Content and Format of an Abbreviated April 18, 1997 Do Do
New Drug Application (ANDA)--Positron
Emission Tomography (PET) Drug
Products--With Specific Information
for ANDAs for Fludeoxyglucose F18
Injection
Letter announcing that the OGD will August 18, 1995 Generic drug Do
now accept the ICH long-term storage
conditions as well as the stability
studies conducted in the past
Letter describing efforts of CDER & October 14, 1994 Do Do
ORA to clarify the responsibilities
of CDER chemistry review scientists
and ORA field investigators in the
new and abbreviated drug approval
process in order to reduce
duplication or redundancy in the
process
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 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 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 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
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 Do
Drug Application and an Abbreviated
Antibiotic Application
Variations in Drug Products that May January 27, 1999 Do Do
Be Included in a Single ANDA
E5 Ethnic Factors in the Acceptability June 10, 1998 ICH draft guidances Do
of Foreign Clinical Data efficacy
[[Page 31266]]
Q6A Specifications: Test Procedures November 25, 1997 ICH draft guidances-- Do
and Acceptance Criteria for New Drug quality
Substances and New Drug Products:
Chemical Substances
Q6B Specifications: Test Procedures June 9, 1998 Do Do
and Acceptance Criteria for
Biotechnological/Biological Products
S4A Duration of Chronic Toxicity November 18, 1997 ICH draft guidances Do
Testing in Animals (Rodent and safety
Nonrodent Toxicity Testing)
E1A The Extent of Population Exposure March 1, 1995 ICH guidances-- Do
to Assess Clinical Safety: for Drugs efficacy
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 January 15, 1998 Do Do
Individual Case Reports
E2C Clinical Safety Data Management: May 19, 1997 Do Do
Periodic Safety Update Reports for
Marketed Drugs
E4 Dose-Response Information to November 9, 1994 Do Do
Support Drug Registration
E6 Good Clinical Practice: 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 December 24, 1997 Do Do
Trials
E9 Statistical Principles for Clinical September 16, 1998 Do Do
Trials
M3 Nonclinical Safety Studies for the November 25, 1997 ICH guidances--joint Do
Conduct of Human Clinical Trials for safety/efficacy
Pharmaceuticals (multidisciplinary)
Q1A Stability Testing of New Drug September 22, 1994 ICH guidances-- Do
Substances and Products quality
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
Q2A Text on Validation of Analytical March 1, 1995 Do Do
Procedures
Q2B Validation of Analytical May 19, 1997 Do Do
Procedures: Methodology
Q3A Impurities in New Drug Substances January 4, 1996 Do Do
Q3B Impurities in New Drug Products May 19, 1997 Do Do
Q3C Impurities: Residual Solvents December 24, 1997 Do Do
Q5A Biotechnological/Biological September 24, 1998 Do Do
Pharmaceutical Products, Viral Safety
Evaluation
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
Q5C Quality of Biotechnological July 10, 1996 Do Do
Products: Stability Testing of
Biotechnology/Biological Products
Q5D Quality of Biotechnological/ September 21, 1998 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 ICH guidances--safety Do
Carcinogenicity Studies of
Pharmaceuticals
S1B Testing for Carcinogenicity in February 23, 1998 Do Do
Pharmaceuticals
S1C Dose Selection for Carcinogenicity March 1, 1995 Do Do
Studies of Pharmaceuticals
S1C(R) Dose Selection for December 4, 1997 Do Do
Carcinogenicity Studies of
Pharmaceuticals: Addendum on a Limit
Dose and Related Notes
S2A Specific Aspects of Regulatory April 24, 1996 Do Do
Genotoxicity Tests for
Pharmaceuticals
S2B Genotoxicity: Standard Battery November 21, 1997 Do Do
Testing
S3A Toxicokinetics: The Assessment of March 1, 1995 Do Do
Systemic Exposure in Toxicity Studies
S3B Pharmacokinetics: Guidance for March 1, 1995 Do Do
Repeated Dose Tissue Distribution
Studies
S5A Detection of Toxicity to September 22, 1994 Do Do
Reproduction for Medicinal Products
S5B Detection of Toxicity to April 5, 1996 Do Do
Reproduction for Medicinal Products:
Addendum on Toxicity to Male
Fertility
[[Page 31267]]
S6 Preclinical Safety Evaluation of November 18, 1997 Do Do
Biotechnology-Derived Pharmaceuticals
E3 Structure and Content of Clinical July 17, 1996 IHC guidances-- Do
Study Reports efficacy
A Revision in Sample Collection Under July 15, 1996 Industry letters Do
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 mechanisms
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
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
Act
Sixth of a series of informal notice April 28, 1988 Do Do
letters about the Act discussing the
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
Regulatory Submissions in Electronic January 28, 1999 Information Do
Format; General Considerations technology
Regulatory Submissions in Electronic January 28, 1999 Do Do
Format; New Drug Applications
Acetaminophen, Aspirin and Codeine December 1, 1993 Labeling Do
Phosphate Tablets/Capsules
Acetaminophen and Codeine Phosphate December 1, 1993 Do Do
Oral Solution/Suspension
Acetaminophen and Codeine Phosphate December 1, 1993 Do Do
Tablets/Capsules
Alprazolam Tablets USP August 1, 1996 Do Do
Amiloride Hydrochloride and September 1, 1997 Do Do
Hydrochlorothiazide Tablets USP
Amlodipine Besylate Tablets September 1, 1997 Do Do
Astemizole Tablets September 1, 1997 Do Do
Atenolol Tablets USP August 1, 1997 Do Do
Barbituate, Single Entity-Class March 1, 1981 Do Do
Labeling
Butalbital, Acetaminophen, Caffeine September 21, 1997 Do Do
and Hydocodone Bitartrate Tablets
Butalbital, Acetaminophen and Caffeine September 1, 1997 Do Do
Capsules/Tablets USP
Butorphanol Tartrate Injection USP October 1, 1992 Do Do
Captopril and Hydrochlorothiazide April 1, 1995 Do Do
Tablets USP
Captopril Tablets February 1, 1995 Do Do
Carbidopa and Levodopa Tablets USP February 1, 1992 Do Do
Chlordiazepoxide Hydrochloride January 1, 1988 Do Do
Capsules
Cimetidine Hydrochloride Injection September 1, 1995 Do Do
Cimetidine Tablets September 1, 1995 Do Do
Cisapride Oral Suspension September 1, 1997 Do Do
[[Page 31268]]
Cisapride Tablets September 1, 1997 Do Do
Clindamycin Phosphate Injection USP September 1, 1998 Do Do
Clorazepate Dipotassium Capsules/ March 1, 1993 Do Do
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 January 1, 1997 Do Do
Tablets
Diltiazem Hydrochloride Extended- September 1, 1995 Do Do
Release Capsules
Diphenoxylate Hydrochloride and April 1, 1995 Do Do
Atropine Sulphate Tablets USP
Diphenoxylate Hydrochloride and April 1, 1995 Do Do
Atropine Sulfate Oral Solution USP
Dipivefrin Hydrochloride Ophthalmic October 1, 1998 Do Do
Solution USP
Dipivefrin Hydrochloride Ophthalmic November 2, 1998 Do Do
Solution, 0.1%
Ergoloid Mesylates Tablets January 1, 1988 Do Do
Fludeoxyglucose F18 Injection January 1, 1997 Do Do
Flurbiprofen Tablets USP January 1, 1994 Do Do
Fluvoxamine Maleate Tablets September 1, 1997 Do Do
Gentamicin Sulfate Ophthalmic Ointment April 1, 1992 Do Do
and Solution USP
Heparin Sodium Injection USP March 1, 1991 Do Do
Hydrocodone Bitartrate and April 1, 1994 Do Do
Acetaminophen Tablets USP
Hydroxyzine Hydrochloride Injection December 1, 1989 Do Do
Hypoglycemic Oral Agents--Federal April 1, 1984 Do Do
Register
Indomethacin Capsules USP September 1, 1995 Do Do
Informal Labeling Guidance Texts for August 1, 1992 Do Do
Estrogen Drug Products--Patient
Labeling
Informal Labeling Guidance Texts for August 1, 1992 Do Do
Estrogen Drug Products--Professional
Labeling
Isoetharine Inhalation Solution March 1, 1989 Do Do
Itraconazole Capsules, USP September 1, 1998 Do Do
Leucovorin Calcium for Injection July 1, 1996 Do Do
Leucovorin Calcium Tablets, USP July 1, 1996 Do Do
Local Anesthetics--Class Labeling September 1, 1982 Do Do
Meclofenamate Sodium Capsules July 1, 1992 Do Do
Medroxyprogesterone Acetate Tablets, September 1, 1998 Do Do
USP
Metaproterenol Sulfate Inhalation May 1, 1992 Do Do
Solution USP
Metaproterenol Sulfate Syrup, USP May 1, 1992 Do Do
Metaproterenol Sulfate Tablets May 1, 1992 Do Do
Metoclopramide Tablets/ Oral Solution, February 1, 1995 Do Do
USP
Naphazoline Hydrochloride Ophthalmic March 1, 1989 Do Do
Solution
Naproxen Sodium Tablets, USP September 1, 1997 Do Do
Naproxen Tablets, USP September 1, 1997 Do Do
Niacin Tablets July 1, 1992 Do Do
Paclitaxel Injection 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 USP October 1, 1995 Do Do
Ranitidine Tablets November 1, 1993 Do Do
Risperidone Oral Solution September 1, 1997 Do Do
Risperidone Tablets September 1, 1997 Do Do
Sulfacetamide Sodium Ophthalmic August 1, 1992 Do Do
Solution/Ointment
Sulfacetamide Sodium and Prednisolone January 1, 1995 Do Do
Acetate Ophthalmic Suspension and
Ointment
Sulfamethoxazole and Phenazopyridine February 1, 1992 Do Do
Hydrochloride Tablets
Sulfamethoxazole and Trimethoprim August 1, 1993 Do Do
Tablets and Oral Suspension
Theophylline Immediate-Release Dosage February 1, 1995 Do Do
Forms
Theophylline Intravenous Dosage Forms September 1, 1995 Do Do
Thiamine Hydrochloride Injection February 1, 1988 Do Do
Tobramycin Sulfate Injection USP May 1, 1993 Do Do
Venlafaxine Hydrochloride Tablets October 1, 1997 Do Do
[[Page 31269]]
Verapamil Hydrochloride Tablets October 1, 1991 Do Do
Vitamin A Capsules February 1, 1992 Do Do
Zolpidem Tartrate Tablets September 1, 1997 Do Do
Content and Format for Geriatric January 21, 1999 Labeling draft Do
Labeling
Non-Contraceptive Estrogen Class October 15, 1998 Do Do
Labeling
Non-Contraceptive Estrogen Drug January 8, 1999 Do Do
Products--Physician and Patient
Labeling
OTC Topical Drug Products for the July 16, 1998 Do Do
Treatment of Vaginal Yeast Infections
(Vulvovaginal Candidiasis)
Therapeutic Equivalence Code Placement January 28, 1999 Do Do
on Prescription Drug Labels and
Labeling
Enforcement Policy on Marketing OTC OTC Do
Combination Products
General Guidelines for OTC Combination Do Do
Products
Upgrading Category III Antiperspirants Do Do
to Category I
OTC Nicotine Substitutes March 1, 1994 OTC draft Do
Points to Consider for OTC Actual Use July 22, 1994 Do Do
Studies
Format and Content of the Nonclinical February 1, 1987 Pharmacology/ Do
Pharmacology/Toxicology Section of an toxicology
Application
Points to Consider in the Nonclinical Do Do
Pharmacology/Toxicology Development
of Topical Drugs Intended to Prevent
the Transmission of Sexually
Transmitted Diseases (STD) and/or for
the Development of Drugs Intended to
Act as Vaginal Contraceptives
Reference Guide for the Nonclinical February 1, 1989 Do Do
Toxicity Studies of Antiviral Drugs
Indicated for the Treatment of Non-
Life Threatening Disease: Evaluation
of Drug Toxicity Prior to Phase I
Clinical Studies
Single Dose Acute Toxicity Testing for August 26, 1996 Do Do
Pharmaceuticals
180-Day Generic Drug Exclusivity Under July 14, 1998 Procedural Do
the Hatch-Waxman Amendments to the
Federal Food, Drug, and Cosmetic Act
Advisory Committees: Implementing November 2, 1998 Do Do
Section 120 of the Food and Drug
Modernization Act of 1997
Enforcement Policy During November 23, 1998 Do Do
Implementation of Section 503A of the
Federal Food, Drug, and Cosmetic Act
Fast Track Drug Development Programs: November 18, 1998 Do Do
Designation, Development, and
Application Review
Implementation of Section 126, July 21, 1998 Do Do
Elimination of Certain Labeling
Requirements, of the FDA
Modernization Act of 1997
National Uniformity for April 9, 1998 Do Do
Nonprescription Drugs Ingredient
Labeling for OTC Drugs
Qualifying for Pediatric Exclusivity June 29, 1998 Do Do
Under Section 505A of the Federal
Food, Drug, and Cosmetic Act
Repeal of Section 507 of the Federal June 15, 1998 Do Do
Food, Drug, and Cosmetic Act
Standards for the Prompt Review of May 15, 1998 Do Do
Efficacy Supplements, Including
Priority Efficacy Supplements
Submitting Debarment Certification October 2, 1998 Procedural draft Do
Statements
Classifying Resubmissions in Response May 14, 1998 User fee Do
to Action Letters
Submitting and Reviewing Complete May 14, 1998 Do Do
Responses to Clinical Holds
----------------------------------------------------------------------------------------------------------------
V. Guidance Documents Issued by the Center for Food Safety and
Applied Nutrition (CFSAN)
[[Page 31270]]
----------------------------------------------------------------------------------------------------------------
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 1996 FDA regulated National Technical
industries Information Service (NTIS),
5285 Port Royal Rd.,
Springfield, VA 22161 (Order
No. PB96-920500)
Compliance Programs Guidance Manual 1995 Do NTIS (Order No. PB95-915499)
Inspection Operations Manual October 1994 Do NTIS (Order No. PB95-913399)
Regulatory Procedures Manual August 1995 Do NTIS (Order No. PB95-265534)
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
FDA Recall Policy 1995 Do Industry Activities Staff
(HFS-565), CFSAN, Food and
Drug Administration, 200 C
St. SW., Washington, DC
20204
Action Levels for Poisonous or 1995 Food and animal feed Do
Deleterious Substances in Human Food industries
and Animal Feed
Pesticides Analytical Manual 1994 Food Industry NTIS (Order No. PB94-911899)
FDA Advisory for Deoxynivanol (DON) in September 16, 1993 Food and animal feed Office of Plant & Dairy Foods
Finished Wheat Products Intended for industries & Beverages (HFS-306),
Human Consumption and in Grain and CFSAN, Food and Drug
Grain By-Products for Animal Feed Administration, 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 Developers of new Office of Premarket Approval
from New Plant Varieties plant food varieties (HFS-200), Food and Drug
Administration, 200 C St.
SW., Washington, DC 20204,
202-418-3100
A Food Labeling Guide September 1994 Food industry Superintendent of Documents,
Government Printing Office,
Washington, DC 20402, 202-
512-1800
Appendix I--Model Small Business Food August 7, 1993 Do Industry Activities Staff
Labeling Exemption Notice (HFS-565), CFSAN, Food and
Drug Administration, 200 C
St. SW., Washington, DC
20204, 202-205-5251
Food Labeling: Questions and Answers August 1993 Do Do
Food Labeling: Questions and Answers: August 1995 Do Superintendent of Documents,
Volume II Government Printing Office,
Washington, DC 20420, 202-
512-1800
Fair Packaging and Labeling Act June 1978 Do NTIS (Order No. PB83-222117)
Requirements and Interpretations
Bacteriological Analytical Manual 7th 1992 FDA regulated AOAC International, 481 North
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 (HFS-565), CFSAN, Food and
Drug Administration, 200 C
St. SW., Washington, DC
20204, 202-205-5251
Fabrication of Single Service 1995 States Milk Safety Branch (HFS-626),
Containers and Closures for Milk and CFSAN, Food and Drug
Milk Products Administration, 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
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), CFSAN, Food and Drug
Administration, 200 C St.
SW., Washington, DC 20204,
202-205-9175
Pasteurized Milk Ordinance 1995 States Milk Safety Branch (HFS-626),
CFSAN, Food and Drug
Administration, 200 C St.
SW., Washington, DC 20204,
202-205-9175
[[Page 31271]]
FDA Nutrition Labeling Manual: A Guide 1993 Food industry Office of Food Labeling (HFS-
for Developing and Using Databases 150), Food and Drug
Administration, 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
(DALS) Industries Industry
Activities Staff
(HFS-565), CFSAN,
Food and Drug
Administration, 200
C St. SW.,
Washington, DC
20204, 202-205-5251
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,
Government Printing Office,
Washington, DC 20402, 202-
512-1800
Manual of Operations National 1992 States Office of Seafood (HFS-407),
Shellfish Sanitation Shellfish Sanitation Branch,
Food and Drug
Administration, 200 C St.
SW., Washington, DC 20204,
202-418-3150
Fish and Fisheries Products Hazards 1996 Seafood industry Office of Seafood (HFS-400),
and Controls Guide Food and Drug
Administration, 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 (HFS-200), Food and Drug
Regulation for Substances Used in Administration, 200 C St.
Food Articles SW., Washington, DC 20204,
202-418-3100
Guidelines for the Preparation of 1996 Do Do
Petition Submissions
Guidelines for Approval of Color 1996 Color or contact lens Do
Additives in Contact Lenses Intended industry
as Colors
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 Do
Additive and Chemical Contaminants in ingredient industry
the Diet
Toxicological Principles for the 1982 Petitioners for food NTIS (Order No. PR-83-170696)
Safety Assessment of Direct Food or color additives
Additives and Color Additives Used in
Food (also known as Redbook I)
Environmental Assessment Technical March 1987 Do NTIS (Order No. PB87-175345-
Handbook AS, A-01)
Preparing Environmental Assessments: August 1990 Do Office of Premarket Approval
General Suggestions (HFS-200), Food and Drug
Administration, 200 C St.
SW, Washington, DC 20204,
202-418-3100
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 Do Do
and Guidance
Toxological Testing of Food Additives 1983 Do Do
[[Page 31272]]
List of Products for Each Product October 8, 1992 Food industry Office of Food Labeling (HFS-
Category 150), Food and Drug
Administration, 200 C St.
SW., Washington, DC 20204,
202-205-4561
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
Interim Guidance on the Voluntary February 10, 1994 Do Do
Labeling of Milk and Milk Products
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 202-205-4168
Clinical Testing of Infant Formulas 1985 Do Do
with Respect to Nutritional
Suitability for Term Infants
Guidelines for the Evaluation of the Infants with 1988 Do
Safety and Suitability of New Infant Allergic Diseases
Formulas for Feeding
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) Food and Drug
Administration, 200 C St.
SW., Washington, DC 20204,
202-418-3150 or via
Internet: FDA Home Page
http://vm.cfsan.fda.gov/
list.html
Guidance Document for Cadmium (Trace January 1993 Do Do
Elements in Seafood)
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 Internet: FDA Home Page http:/
Biotechnology /vm.cfsan.fda.gov
Bovine Spongiform Encephalopathy (BSE) 1997 Do Office of Plant and Dairy
In Products for Human Use Foods and Beverages (HFS-
302), CFSAN, Food and Drug
Administration, 200 C St.
SW., Washington, DC 20204,
202-205-9175 or via
Internet: FDA Home Page
http://www.fda.gov/opacom/
morechoices/industry/
guidance/gelguide.htm
Shellfish Sanitation Model Ordinance 1995 States Shellfish Program
Implementation Branch,
Office of Field Programs
(HFS-628), Food and Drug
Administration, 200 C St.
SW., Washington, DC 20204,
202-205-8137
Draft Working Guide to Minimize 1998 Farmers and food Food Safety Initiative (HFS-
Microbial Hazards for Fresh Fruits packers 3), Food and Drug
and Vegetables Administration, 200 C. St.
SW, Washington, DC 20204 or
[email protected]
Iron-Containing Supplements and Drugs: 1997 Dietary supplement Office of Special
Label Warning and Unit Dose manufacturers: small Nutritionals (HFS-450), Food
Packaging; Small Entity Compliance entities and Drug Administration, 200
Guide C St. SW., Washington, DC
20204
Partial List of Enzyme Preparations 1998 FDA regulated Office of Premarket Approval
That are Used in Foods industry (HFS-200), Food and Drug
Administration, 200 C St.
SW., Washington, DC 20204
Partial List of Microorganisms and 1998 Do Do
Microbial-Derived Ingredients That
Are Used in Food
[[Page 31273]]
Fish and Fishery Products Hazards and January 1998 Do Office of Seafood (HFS-400),
Controls Guide, 2nd Edition Food and Drug
Administration, 200 C St.
SW., Washington, DC 20204
HACCP Regulations for Fish and Fishery 1997 Do Do
Products: Questions and Answers
Notification of a Health Claim or 1998 Do Office of Food Labeling (HFS-
Nutrient Content Claim Based on an 150), Food and Drug
Authoritative Statement of a Administration, 200 C St.
Scientific Body SW., Washington, DC 20204,
202-205-5099
Small Business Juice Labeling: 1998 Do Do
Questions and Answers
FDA Nutrition Labeling Manual, A Guide March 1998 Do Do
for Developing and Using Data Bases
HACCP Regulation for Fish and Fishery January 1999 Seafood processors Office of Seafood (HFS-400),
Products: Questions and Answers, Food and Drug
Issue Three, Revised Administration, 200 C St.
SW., Washington, DC 20204,
202-418-3150
Foods--Adulteration Involving Hard or February 1999 FDA field offices Office of Plant and Dairy
Sharp Foreign Objects (CPG) Foods and Beverages (HFS-
300), Food and Drug
Administration, 200 C St.
SW., Washington, DC 20204
Food Additive Petition Expedited January 1999 FDA personnel and Office of Premarket Approval,
Review regulated industry Food and Drug
Administration, 200 C St.
SW., Washington, DC 20204,
202-418-3074,
[email protected] OR
http://vm.cfsan.fda.gov/dms/
opa-expe.html
Use of Antibiotic Resistance Marker September 1998 FDA regulated D[email protected] OR
Genes in Transgenic Plants industry http://vm.cfsan.fda.gov//dms/
opa-armg.html
Changes to the ``Pesticides and December 30, 1998 FDA districts FOI/Domestic Programs Branch
Industrial Chemicals in Domestic (HFS-636), Office of Field
Foods'' Compliance Program for FY 99 Programs, Food and Drug
Administration, 200 C St.
SW., Washington, DC 20204,
202-205-4771
FY 99 Mycotoxin Collection and Sample November 13, 1998 Do Do
Analysis Schedule
Revisions to the EHEC Method November 23, 1998 Do Do
Vibrio Vulnificus and Vibrio June 17, 1998 Do Do
parahaemolyticus in Retail Shell
Oysters CFSAN Assignment 98-7
Revisions to Att F ``Special Survey September 30, 1998 Do Do
Obligations--Dioxins and Furans in
Food'' of the Pesticides and
Industrial Chemicals Domestic Food
Compliance Program for FY99
Collection and Analyses of Physical November 30, 1998 Do Do
Sample to Support Undeclared Allergen
Cases: NLEA and General Labeling
Requirements; Domestic Compliance
Program
Assignment to Assure Unpasteurized September 21, 1998 Do Do
Juice Manufacturers and Imported
Juice Products Provide Required Label
Warnings, Placards, and/or meet the 5
log Pathogen Reduction Requirement
Assignment to Assure Unpasteurized November 3, 1998 Do Do
Juice Manufacturers and Imported
Juice Products Provide Required Label
Warnings, Placards, and/or meet the 5
log Pathogen Reduction Requirement
Pesticides in Imported Ginseng (Field September 17, 1998 FDA districts FOI/Imports Branch (HFS-606),
Assignment) Office of Field Programs,
Food and Drug
Administration, 200 C St.
SW., Washington, DC 20204
Radionuclides in Foods October 2, 1998 Do Do
Letters to Manufacturers of Prepared August 21, 1998 Manufacturers of Office of Field Programs (HFS-
Sandwiches prepared sandwiches 600), Food and Drug
Administration, 200 C St.
SW., Washington, DC 20204,
202-205-5194 or
JohnThomas@[email protected],
FAX 292-260-0133
----------------------------------------------------------------------------------------------------------------
[[Page 31274]]
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)
----------------------------------------------------------------------------------------------------------------
Guideline 3--General Principles for July 1994 Animal drug industry Internet via: http://
Evaluating the Safety of Compounds www.fda.gov/cvm or
Used in Food-Producing Animals Communications Staff (HFV-
12), CVM, Food and Drug
Administration, 7500
Standish Pl., Rockville, MD
20855, 301-594-1755, FAX 301-
594-1831
Guideline 4--Guidelines for Efficacy Do Do
Studies for Systemic Sustained
Release Sulfonamide Boluses for
Cattle
Guideline 5--Stability Guidelines December 1990 Do Do
Guideline 6--Guidelines for Submitting Do Do
NADA's for Generic Drugs Reviewed by
NAS/NRC
Guideline 9--Preclearance Guidelines October 1975 Do Do
for Production Drugs
Guideline 10--Amendment of Section October 1975 Do Do
II(G)(1)(b)(4) of the Preclearance
Guidelines
Guideline 13--Guidelines for January 1985 Do Do
Evaluation of Effectiveness of New
Animal Drugs for Use in Free-Choice
Feeds
Guideline 14--Guideline and Format for Do Do
Reporting the Details of Clinical
Trials Using An Investigational New
Animal Drug in FOOD Producing Animals
Guideline 15--Guideline and Format for February 1977 Do Do
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 Do Do
Animal Feeds: Human Health Safety
Criteria
Guideline 19--Antibacterial Drugs in Do Do
Animal Feeds: Animal Health Safety
Criteria
Guideline 20--Antibacterial Drugs in Do Do
Animal Feeds: Antibacterial
Effectiveness Criteria
Guideline 22--Guideline Labeling of 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 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
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
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--Animal Drug 1994 Do Do
Manufacturing Guidelines, 1994
Guideline 43--Guidance on Generic October 1995 Do Do
Animal Drug Products Containing
Fermentation-Derived Drug Substances
[[Page 31275]]
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 Do
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 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 for Industry: January 1999 Do Do
Submitting a Notice of Claimed
Investigational Exemption in
Electronic Format to CVM via E-Mail
Guidance 61--Guidance for Industry-- January 1999 Do Do
FDA Approval of Animal Drugs for
Minor Uses and for Minor Species
Guideline 62--Guidance for Industry-- August 1997 Do Do
Consumer-Directed Broadcast
Advertisements
Guideline 63--Guidance for Industry-- December 1997 Do Do
Validation of Analytical Procedures:
Definition and Terminology--Draft
Guidance
Guideline 64--Guidance for Industry-- December 1997 Do Do
Validation of Analytical Procedures:
Methodology--Draft Guidance
Guideline 65--Guidance for Industry-- November 1997 Do Do
Industry-Supported Scientific and
Educational Activities
Guideline 66--Guidance for Industry-- January 1998 Do Do
Professional Flexible Labeling of
Antimicrobial Drugs--Draft Guidance
Guideline 67--Guidance for Industry-- February 1998 Do Do
Small Entities Compliance Guide for
Renderers
Guideline 68--Guidance for Industry-- February 1998 Do Do
Small Entities Compliance Guide for
Protein Blenders, Feed Manufacturers,
and Distributors
Guideline 69--Guidance for Industry-- February 1998 Do Do
Small Entities Compliance Guide for
Feeders of Ruminant Animals With On-
Farm Feed Mixing Operations
Guideline 70--Guidance for Industry-- February 1998 Do Do
Small Entities Compliance Guide for
Feeders of Ruminant Animals Without
On-Farm Feed Mixing Operations
Guideline 71--Guidance for Industry-- April 1998 Do Do
Use of Human Chorionic Gonadotropic
(HCG) as a Spawning Aid for Fish
Guideline 72--Guidance for Industry-- May 1998 Do Do
GMP's for Medicated Feed
Manufacturers Not Required to
Register and Be Licensed With FDA
[[Page 31276]]
Guideline 73--Draft Guidance for July 1998 Do Do
Industry--Stability Testing of New
Animal Drug Substances and Products
Guideline 74--Draft Guidance for July 1998 Do Do
Industry--Stability Testing for New
Dosage Forms of New Animal Drugs
Guideline 75--Guidance for Industry-- July 1998 Do Do
Stability Testing: Photostability
Testing of New Animal Drug Substances
and Products: Draft Guidance
Guideline 76--Guidance for Industry-- July 1998 Do Do
Questions and Answers--BSE Feed
Regulation
Guideline 77--Guidance for Industry-- August 1998 Do Do
Interpretation of On-Farm Feed
Manufacturing and Mixing Operations--
Draft Guidance
Guideline 78--Guidance for Industry-- November 1998 Do Do
Evaluation of the Human Health Impact
of the Microbial Effects of
Antimicrobial New Animal Drugs
Intended for Use in Food-Producing
Animals--Draft Guidance
----------------------------------------------------------------------------------------------------------------
VII. 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 August 1996 FDA staff personnel National Technical
Information Service (NTIS),
5285 Port Royal Rd.,
Springfield, VA 22161 (Order
No. PB96-915499) or via
Internet www.fda.gov/ora/
compliance_ref/cpg/
cpgtc.html
Compliance Policy Guide Medical Device August 27, 1998 Do Division of Compliance Policy
Warning Letter Draft Pilot (HFC-230), Office of
Enforcement, Food and Drug
Administration, 5600 Fishers
Lane, Rockville, MD 20857,
301-827-0420 or via Internet
www.fda.gov/ora/compliance_
ref/dev_pl.pdf
Compliance Policy Guide-DRAFT January 5, 1998 Do Division of Compliance Policy
Commercialization of In Vitro or via Internet at
Diagnostic Devices (IVD's) Labeled www.fda.gov/cdrh/comp/
for Research Use Only or ivddrfg.html
Investigational Use Only
Compliance Policy Guide 675.400 (CPG November 13, 1998 Do Division of Compliance Policy
7126.24) REVISION Rendered Animal or via Internet at
Feed Ingredients www.fda.gov/ora/compliance_
ref/cpg/cpgvet/
cpg675.400.html
Compliance Policy Guide--DRAFT August 28, 1998 Do Division of Compliance Policy
Distributor Medical Device Reporting or via Internet at
www.fda.gov/ora/compliance_
ref/cpg_mdr3.txt
Compliance Policy Guide 257.100 NEW December 21, 1998 Do Division of Compliance Policy
Deferral of Source Plasma Donors Due or via Internet at
to Red Cell Loss During Collection of www.fda.gov/ora/compliance_
Source Plasma by Automated ref/cpg/default.html
Plasmapheresis
FDA/ORA International Inspection May 1997 Do Division of Emergency &
Manual and Travel Guide Investigational Operations
(HFC-130), Food and Drug
Administration, 5600 Fishers
Lane, Rockville, MD 29857 or
via Internet www.fda.gov/ora/
inspect_ref/itob/itob.html
Glossary of Computerized System and August 1995 Do NTIS (Order No. PB96-127352)
Software Development Terminology or via Internet www.fda.gov/
ora/inspect_ref/igs/
iglist.html
[[Page 31277]]
Import Alerts continuously Do Freedom of Information Staff
(HFI-35), Food and Drug
Administration, 5600 Fishers
Lane, Rockville, MD 20857 or
via Internet www.fda.gov/ora/
fiars/ora_import_
alerts.html
Investigations Operations Manual January 1999 Do Division of Emergency and
Investigational Operations
(HFC-130), Office of
Regional Operations, Food
and Drug Administration,
5600 Fishers Lane,
Rockville, MD 20857, 301-443-
3276 or via Internet
www.fda.gov/ora/inspect_ref/
iom/iomtc.html
Investigations Operations Manual- July 1998 Do Do
REVISION: Chapter 4--Sampling
Investigations Operations Manual- July 1998 Do Do
REVISION: Chapter 5--Establishment
Inspection
Laboratory Procedures Manual June 1994 Do Division of Field Science
(HFC-141), Food and Drug
Administration, 5600 Fishers
Lane, rm. 12-41, Rockville,
MD 20857, ATTN: Donna Porter
or via Internet www.fda.gov/
ora/science_ref/lpm/
lpmtc.html
Regulatory Procedures Manual August 1997 Do NTIS (Order No. PB97-196182)
or via Internet www.fda.gov/
ora/compliance_ref/rpm/
rpmtc.html
Regulatory Procedures Manual: UPDATE/ March 1998 Do Division of Compliance
New Subchapter/ Application Integrity Policy, or via Internet
Policy www.fda.gov/ora/compliance_
ref/rpm/rpmtc.html
Regulatory Procedures Manual: UPDATE March 1998 Do Do
Subchapter/Warning Letters
Regulatory Procedures Manual: UPDATE/ April 1998 Do Do
REVISION Subchapter/Import Procedures
Regulatory Procedures Manual; UPDATE/ April 1998 Do Do
REVISION Subchapter/Priority
Enforcement Strategy for Problem
Importers
Regulatory Procedures Manual: UPDATE/ April 1998 Do Do
REVISION Subchapter/Import Procedures
Regulatory Procedures Manual: UPDATE/ April 1998 Do Do
REVISION Subchapter/Notice of
Sampling
Regulatory Procedures Manual: UPDATE/ May 1998 Do Do
NEW Subchapter/Granting and Denying
Transportation and Exportation (T&E)
Entries
Regulatory Procedures Manual: UPDATE/ June 1998 Do Division of Compliance Policy
REVISION Subchapter/Seizure or via Internet at
www.fda.gov/ora/compliance_
ref/rpm_new2/ch6.html
Regulatory Procedures Manual: UPDATE/ June 1998 Do Division of Compliance Policy
REVISION Subchapter/Supervisory or via Internet at
Charges www.fda.gov/ora/compliance_
ref/rpm_new2/ch9chgs.html
Regulatory Procedures Manual: NEW July 1998 Do Division of Compliance Policy
Subchapter/Civil Penalties-- or via Internet at
Electronic Product Radiation Control www.fda.gov/ora/compliance_
ref/ch6civpen.html
Guide to Inspections of Bulk May 1994 Do NTIS (Order No. PB96-127154)
Pharmaceutical Chemicals or via Internet www.fda.gov/
ora/inspect_ref/igs/
iglist.html
Guide to Inspections of Pharmaceutical July 1993 Do NTIS (Order No. PB96-127279)
Quality Control Laboratories or via Internet www.fda.gov/
ora/inspect_ref/igs/
iglist.html
Guide to Inspections of July 1993 Do NTIS (Order No. PB96-127287)
Microbiological Pharmaceutical or via Internet www.fda.gov/
Quality Control Laboratories ora/inspect--ref/igs/
iglist.html
Guide to Inspections of Validation of July 1993 Do NTIS (Order No. PB96-127246)
Cleaning Processes or via Internet www.fda.gov/
ora/inspect_ref/igs/
iglist.html
Guide to Inspections of Lyophilization July 1993 Do NTIS (Order No. PB96-127253)
of Parenterals or via Internet www.fda.gov/
ora/inspect_ref/igs/
iglist.html
Guide to Inspections of High Purity July 1993 Do NTIS (Order No. PB96-127261)
Water Systems or via Internet www.fda.gov/
ora/inspect_ref/igs/
iglist.html
[[Page 31278]]
Guide to Inspections of Dosage Form October 1993 Do NTIS (Order No. PB96-127212)
Drug Manufacturers-CGMPs or via Internet www.fda.gov/
ora/inspect_ref/igs/
iglist.html
Guide to Inspections of Oral Solid January 1994 Do NTIS (Order No. PB96-127345)
Dosage Forms Pre/Post Approval Issues or via Internet www.fda.gov/
for Development and Validation ora/inspect--ref/igs/
iglist.html
Guide to Inspections of Topical Drug July 1994 Do NTIS (Order No. PB96-127394)
Products or via Internet www.fda.gov/
ora/inspect_ref/igs/
iglist.html
Guide to Inspections of Sterile Drug July 1994 Do NTIS (Order No. PB96-127295)
Substance Manufacturers or via Internet www.fda.gov/
ora/inspect_ref/igs/
iglist.html
Guide to Inspections of Oral Solutions August 1994 Do NTIS (Order No. PB96-127147)
and Suspensions or via Internet www.fda.gov/
ora/inspect_ref/igs/
iglist.html
Guide to Inspections of Nutritional February 1995 Do NTIS (Order No. PB96-127378)
Labeling and Education Act (NLEA) or via Internet www.fda.gov/
Requirements ora/inspect--ref/igs/
iglist.html
Guide to Inspections of Interstate April 1995 Do NTIS (Order No. PB96-127386)
Carriers and Support Facilities or via Internet www.fda.gov/
ora/inspect_ref/igs/
iglist.html
Guide to Inspections of Dairy Product April 1995 Do NTIS (Order No. PB96-127329)
Manufacturers or via Internet www.fda.gov/
ora/inspect_ref/igs/
iglist.html
Guide to Inspections of Miscellaneous May 1995 Do NTIS (Order No. PB96-127220)
Foods Vol. I or via Internet www.fda.gov/
ora/inspect_ref/igs/
iglist.html
Guide to Inspections of Miscellaneous September 1996 Do NTIS (Order No. PB97-196133)
Foods Vol. II or via Internet www.fda.gov/
ora/inspect_ref/igs/
iglist.html
Guide to Inspections of Low Acid November 1996 Do NTIS (Order No. PB97-196141)
Canned Foods Manufacturers, Part 1 - or via Internet www.fda.gov/
Administrative Procedures/Scheduled ora/inspect--ref/igs/
Processes iglist.html
Guide to Inspections of Low Acid April 1997 Do NTIS (Order No. PB97-196158)
Canned Foods Manufacturers, Part 2- or via Internet www.fda.gov/
Processes/Procedures ora/inspect--ref/igs/
iglist.html
Guide to Inspections of Cosmetic February 1995 Do NTIS (Order No. PB96-127238)
Product Manufacturers or via Internet www.fda.gov/
ora/inspect_ref/igs/
iglist.html
Guide to Inspections of Blood Banks September 1994 Do NTIS (Order No. PB96-127303)
or via Internet www.fda.gov/
ora/inspect_ref/igs/
iglist.html
Guide to Inspections of Source Plasma December 1994 Do NTIS (Order No. PB96-127360)
Establishments or via Internet www.fda.gov/
ora/inspect_ref/igs/
iglist.html
Guide to Inspections of Infectious June 1996 Do NTIS (Order No. PB96-199476)
Disease Marker Testing Facilities or via Internet www.fda.gov/
ora/inspect_ref/igs/
iglist.html
Biotechnology Inspections Guide November 1991 Do NTIS (Order No. PB96-127402)
or via Internet www.fda.gov/
ora/inspect_ref/igs/
iglist.html
Guide to Inspections of Computerized February 1983 Do NTIS (Order No. PB96-127337)
Systems in Drug Processing or via Internet www.fda.gov/
ora/inspect_ref/igs/
iglist.html
Guide to Inspections of Foreign September 1995 Do NTIS (Order No. PB96-127311)
Medical Device Manufacturers or via Internet www.fda.gov/
ora/inspect_ref/igs/
iglist.html
Guide to Inspections of Foreign May 1996 Do NTIS (Order No. PB96-199468)
Pharmaceutical Manufacturers or via Internet www.fda.gov/
ora/inspect_ref/igs/
iglist.html
Mammography Quality Standards Act January 1998 Do NTIS (Order No. PB98-127178)
(MQSA) Auditors Guide or via Internet www.fda.gov/
ora/inspect_ref/igs/
iglist.html
Guide to Inspections of December 1997 Do NTIS (Order No. PB98-127152)
Electromagnetic Compatibility Aspects or via Internet www.fda.gov/
of Medical Device Quality Systems ora/inspect--ref/igs/
iglist.html
[[Page 31279]]
Guide to Inspections of Grain Product March 1998 Do Division of Emergency and
Manufacturers Investigational Operations
(HFC-130), Office of
Regional Operations, Food
and Drug Administration,
5600 Fishers Lane,
Rockville, MD 20857, 301-443-
3276
Guide to Bioresearch Monitoring February 1998 Do Do
Inspections of In Vitro Devices
Guide to Inspections of Viral March 1998 Do Do
Clearance Processes for Plasma
Derivatives
Guide to Traceback of Fresh Fruits and August 1998 Do Do
Vegetables Implicated in
Epidemiological Investigations
Guide to Inspections of Computerized August 1998 Do Do--Internet at www.fda.gov/
Systems in the Food Processing ora/inspect--ref/igf/
Industry iglist.html
Guideline for the Monitoring of January 1988 FDA regulated Division of Compliance Policy
Clinical Investigators industry (HFC-230), Office of
Enforcement, Food and Drug
Administration, 5600 Fishers
Lane, Rockville, MD 20857,
301-827-0420
Computerized Systems Used in Clinical June 18, 1997 Do Do
Trials-DRAFT
Compliance Program 7348.808: Revised August 17, FDA staff personnel Do--Internet http://
Bioresearch Monitoring; Good 1998 www.fda.gov/ora/compliance_
Laboratory Practices (Nonclinical) ref/bimo/default.html
Compliance Program 7348.810: Sponsors, Revised October Do Do
Contract Research Organizations and 30, 1998
Monitors
Compliance Program 7348.811: Revised September Do Do
Bioresearch Monitoring; Clinical 2, 1998
Investigations
Food Laboratory Practice Program October 1, 1991 Do Division of Compliance Policy
(Nonclinical Laboratories) 7348.808A;
EPA Data Audit Inspections
Compliance Program 7348.809; August 18, 1994 Do Do
Bioresearch Monitoring; Institutional
Review Board
Good Laboratory Practice Regulations August 1979 Do Do--Internet at www.fda.gov/
Management Briefings ora/compliance--ref/bimo/
default.html
----------------------------------------------------------------------------------------------------------------
VIII. Guidance Documents Issued by the Office of the Commissioner
and 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
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry; Exports June 1998 Regulated industry Internet via www.fda.gov/
and Imports under the FDA Export opacom/fedregister/
Reform and Enhancement Act of 1996 frexport.html
FDA's Development, Issuance and Use of February 1997 FDA personnel 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 Broadcast February 1997 Do Do
Advertisements
Direct Final Rule Guidance November 1997 FDA personnel Internet via www.fda.gov/
opacom/morechoices/industry/
guidedc.htm or Lisa Helmanis
(301-443-3480)
Small Entities Compliance Guide: 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 & Tobacco--Frequently Asked July 1997 Do Do
Questions about the New Regulations
(Draft)
Children & Tobacco--A Retailer's Guide October 1997 Do Do
to the New Federal Regulations
Children & Tobacco--A Guide to the the October 1997 Do Do
New Federal Regulations
[[Page 31280]]
FDA's Standards Policy October 1995 FDA personnel and 60 FR 53078, October 11, 1995
regulated industry or Office of Policy (301-827-
3360)
Policy & Guidance Handbook for FDA 1994 FDA personnel National Technical
Advisory Committees Information Service (NTIS),
5285 Port Royal Rd.,
Springfield, VA 22161, 703-
487-4650 (Order No. PB94-
158854)
----------------------------------------------------------------------------------------------------------------
Dated: June 4, 1999.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 99-14752 Filed 6-9-99; 8:45 am]
BILLING CODE 4160-01-F