21 CFR Part 814 - PREMARKET APPROVAL OF MEDICAL DEVICES

Subpart A - General (§§ 814.1 - 814.19)
Subpart B - Premarket Approval Application (PMA) (§§ 814.20 - 814.39)
Subpart C - FDA Action on a PMA (§§ 814.40 - 814.47)
Subpart D - Administrative Review [Reserved]
Subpart E - Postapproval Requirements (§§ 814.80 - 814.84)
Subparts F-G [Reserved]
Subpart H - Humanitarian Use Devices (§§ 814.100 - 814.126)

Authority:

21 U.S.C. 351, 352, 353, 360, 360c-360j, 371, 372, 373, 374, 375, 379, 379e, 381.

Source:

51 FR 26364, July 22, 1986, unless otherwise noted.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.

United States Code

U.S. Code: Title 5 - GOVERNMENT ORGANIZATION AND EMPLOYEES

§ 552 - Public information; agency rules, opinions, orders, records, and proceedings

U.S. Code: Title 21 - FOOD AND DRUGS