21 CFR Part 820 - QUALITY SYSTEM REGULATION

Authority:

21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, 383; 42 U.S.C. 216, 262, 263a, 264.

Source:

61 FR 52654, Oct. 7, 1996, 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 21 - FOOD AND DRUGS

§ 351 - Adulterated drugs and devices

§ 352 - Misbranded drugs and devices

§ 360 - Registration of producers of drugs or devices

§ 360c - Classification of devices intended for human use

§ 360d - Performance standards

§ 360e - Premarket approval

§ 360h - Notification and other remedies

§ 360i - Records and reports on devices

§ 360j - General provisions respecting control of devices intended for human use

§ 360l - Postmarket surveillance

§ 371 - Regulations and hearings

§ 374 - Inspection

§ 381 - Imports and exports

§ 383 - Office of International Relations