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Appendix B: Managing the Risks From Medical Product Use

Table of Contents: Managing the Risks From Medical Product Use: Creating a Risk Management Framework

Previous Section : Appendix A


Examples of Legislation, Regulations, and
Guidance for Industry Related to Postmarketing


The following are examples of legislation, regulations, and guidance for industry that relate to the Agency's postmarketing efforts. This is not intended to be a complete listing of related documents.



Federal Food, Drug, and Cosmetic Act, 21 U.S.C. Sections 201 et seq.


Safe Medical Devices Act of 1990 (SMDA). Introduced requirement for Medical Device Reporting (MDR) by User Facilities (effective 11/28/91) and Domestic Distributors.

Medical Device Amendments of 1992 (MDA). Provided FDA with authority to require reports for adverse events deemed "significant adverse device experiences."

Food and Drug Administration Modernization Act of 1997, effective February 19, 1998.


21 CFR 310.305 Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications

21 CFR 312.32 Investigational new drug (IND) safety reports

21 CFR 314.80 Postmarketing reporting of adverse drug experiences

21 CFR 600.14 - Reporting of errors (Biologics)

21 CFR 600.80 Postmarketing reporting of adverse experiences (for licensed biological products)

21 CFR 600.81 Distribution reports (for licensed biological products)

21 CFR 610.2 - Requests for samples and protocols; official release

21 CFR 803 - Medical device reporting

21 CFR 804 - Medical device distributor reporting


Federal Register Notices

Form for Reporting Serious Adverse Events and Product Problems With Human Drug and Biological Products and Devices; Availability (MedWatch) (58 FR 31596) June 3, 1993.

Final Rule: Medical Device Distributor Reporting. Collection requirements for all wholesale distributors (including importers) codified in 21 CFR 804, September 1, 1993.

Final Rule: Medical Device User Facility and Manufacturer Reporting, Certification and Registration (effective date 4/11/96). Revised final reporting requirements for manufacturers and user facilities under SMDA and MDA, including requirement for use of 3500A form, December 11, 1995.

Final Rule (Extension of Effective Date): Medical Devices; Medical Device User Facility and Manufacturer Reporting, Certification and Registration; Office of Management and Budget Approval; notification of approval of information collection requirements (extended effective date to 7/31/96 for final regulation) (61 FR 16043), April 11, 1996.

Final Rule (Stay of Effective Date; Revocation): Medical Devices; Medical Device Distributor and Manufacturer Reporting; Certification, Registration, Listing, and Premarket Notification Submission; changes to annual certification and U.S. designated agents (61 FR 38345), July 23, 1996.

Final Rule (Stay on Requirement for Denominator Data): Medical Devices; Medical Device Reporting; Baseline Reports; Stay of Effective Date, (61 FR 39868), July 31, 1996.

Final Rule (Revoked Requirement for Increased Frequency Reports as Expedited Reports Because These Reports Have Not Contributed to Timely Identification of Safety Problems); Postmarketing Expedited Adverse Experience Reporting for Human Drug and Licensed Biological Products; Increased Frequency Reports (62 FR 34166), June 25, 1997.

Direct Final Rule and Proposed Rule (Revised 21 CFR 803 in accordance with changes under the Modernization Act and moved requirements for importers and distributors from 21 CFR 804 to 21 CFR 803): Medical Device Reporting: Manufacturer Reporting, Importer Reporting, User Facility Reporting, and Distributor Reporting (63 FR 26069), May 12, 1998.

Direct Final Rule (withdrew final rule published May 12, 1998, due to significant comment): Medical Device Reporting: Manufacturer Reporting, Importer Reporting, User Facility Reporting, Distributor Reporting (63 FR 45716), August 27, 1998.

Agency Information Collection Activities; Proposed Collection; MedWatch: The FDA Medical Products Reporting Program; Comment Request (proposed revision of MedWatch Forms 3500 and 3500A to incorporate new data elements) (63 FR 63064), November 10, 1998.

Guidances for the Center for Drugs and the Center for Biologics

Postmarketing Reporting of Adverse Drug Experiences (March 1992)

Postmarketing Reporting of Adverse Experiences - Biologics (October 1993)

Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products Clarification of What to Report (August 1997)

Enforcement of the Postmarketing Adverse Drug Experience Reporting Regulations (August 1997)

How to Complete the Vaccine Adverse Reporting System Form (September 1998)

Guidances for Devices

Overview of FDA Modernization Act of 1997 (March 11, 1998)

Medical Device Reporting for Manufacturers (March 1, 1997)

Medical Device Reporting for User Facilities (April 1, 1996)

Medical Device Reporting: An Overview (April 1, 1996)

Medical Device Reporting for Distributors (April 1, 1996)

Instructions for Completing Form 3500A with Coding Manual for Form 3500A (December 15, 1995)

Remedial Action Exemption - E1996001 (July 30, 1996)

Breast Implant - E1996002 (August 7, 1996)

Needlestick and Blood Exposure - E1996003 (August 9, 1996)

Intraocular Lenses - E1996004 (August 7, 1996)

Variance from Manufacturer Report Number Format - MDR Letter (July 16, 1996)

Variance from Manufacturer Report Number Format (Variance 5) (August 12, 1996)


International Conference on Harmonisation Guidances

The purpose of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is to recommend global standards that pharmaceutical manufacturers can follow when dealing with regulators to reduce duplication of effort and focus on the safety and efficacy of their products. Five safety-relevant ICH expert working groups met through 1998 and have issued their final guidances, which FDA is now implementing.

E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (March 1, 1995)

E2B Data Elements for Transmission of Individual Case Reports (March 1, 1995)


E2C Clinical Safety Data Management: Periodic Safety Update Reports (May 19, 1997)


Modernization Act Guidances For Devices

Guidance for Industry, Review Staff, and the Clinical Community issued November 21, 1998

Guidance Procedures to Determine Postmarket Surveillance Strategies issued February 2, 1998

Guidance on Procedures for Review of Postmarket Surveillance Submissions February 19, 1998

Safe Medical Devices Act (SMDA) to FDAMA: Guidance on FDA's Transition Plan for Existing Postmarket Surveillance Protocols July 22, 1998

Next Section : Appendix C