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U.S. Department of Health and Human Services

Medical Devices

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PMA Regulations

Please note: As of October 1, 2002, FDA charges a fee for review of Premarket Approvals

CFR Title 21 Database
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm

21 CFR 814 Premarket Approval of Medical Devices

21 CFR 54 Financial Disclosure by Clinical Investigators

21 CFR 801 Labeling

21 CFR 820 Quality System Regulation

Federal Register Notices

The Federal Register (FR) is the official daily publication for rules, proposed rules, and notices of federal agencies and organizations, as well as Executive Orders and other Presidential Documents. In order to create or revise an existing regulation, FDA will publish a proposed rule in the FR and request comments. FDA will then evaluate all comments received and publish a final rule. Once a proposed rule is finalized, it is published in the Code of Federal Regulations (CFR).

The following list of Federal Register notices site the original publication of the PMA regulation and subsequent changes to the regulation. The sections of 21 CFR 814 affected by the Federal Register notice are noted after the Federal Register date. Changes to 21 CFR 814 regarding Humanitarian Use Devices are listed separately.

Premarket Approval

July 22, 1986

Premarket Approval of Medical Devices

November 7, 1986

814.15 - Research conducted outside of the U.S.
814.20 - Application

December 2, 1986

814.20 - Application
814.15 - Research conducted outside of the U.S.
814.39 - PMA supplements
814.82 - Postapproval requirements
814.84 - Reports

October 8, 1988

Medical Devices; 30-Day Notices and 135-Day PMA Supplement Review; Final Rule
814.39 PMA supplements

March 27, 1990

814.20 - Application

December 10, 1992

814.44 - Procedures for review of a PMA

April 5, 1996

814.3 - Definitions
814.47 - Temporary suspension of approval of a PMA

June 26, 1996

814.3 – Definitions

October 2 1996

814.9 – Confidentiality

July 29, 1997

National Environmental Policy Act; Revision of Policies and Procedures

814.20 - Application

January 30, 1998

Revising the Announcement Procedures for Approvals and Denials of Premarket Approval Applications

814.44 - Procedures for review of a PMA
814.45 - Denial of a approval of a PMA

February 2, 1998

Financial Disclosure by Clinical Investigators

814.20 - Application
814.42 - Filing a PMA

March 31, 2000

Medical Devices; Information Processing Procedures; Obtaining, Submitting, Executing, and Filing of Forms: Change of Addresses

814.20 - Application

September 19, 2000

Administrative Practices and Procedures; Good Guidance Practices

814.20 - Application

Humanitarian Use Devices

June 26, 1996
Subpart H - Humanitarian Use Devices
February 2, 1998

Financial Disclosure by Clinical Investigators

814.12 - Filing an HDE

November 3, 1998

Humanitarian Use of Devices

814.100 - Purpose and Scope
814.104 - Original applications
814.106 - HDE amendments and resubmitted HDEs
814.108 - Supplemental Applications
814.112 - Filing an HDE
814.114 - Timeframes for reviewing an HDE
814.116 - Procedures for review of an HDE
814.118 - Denial of approval or withdrawal of approval of an HDE
814.120 - Temporary suspension of an approval of an HDE
814.124 - Institutional Review Board requirements
814.126 - Postapproval requirements and reports

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