PMA Regulations
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 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