|
| FDA Home Page | CDRH Home Page | Search | A-Z Index |  |
|
 | ||
 |
|||
    |
|||
Please note: as of October 1, 2002, FDA charges fees for review of Premarket Notification 510(k)s and Premarket Approvals
RegulationsCFR Title 21 Database 21 CFR 814 Premarket Approval of Medical Devices 21 CFR 54 Financial Disclosure by Clinical Investigators 21 CFR 820 Quality System Regulation
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
November 7, 1986
December 2, 1986
October 8, 1988
March 27, 1990
December 10, 1992
April 5, 1996
June 26, 1996
October 2 1996
July 29, 1997
January 30, 1998
February 2, 1998
March 31, 2000
September 19, 2000
Humanitarian Use Devices June 26, 1996
February 2, 1998
November 3, 1998
Updated 11/1/2002
|
|||
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH
