21 CFR Part 801, Subpart B - Labeling Requirements for Unique Device Identification

eCFR
Authorities (U.S. Code)

§ 801.20 Label to bear a unique device identifier.
§ 801.30 General exceptions from the requirement for the label of a device to bear a unique device identifier.
§ 801.35 Voluntary labeling of a device with a unique device identifier.
§ 801.40 Form of a unique device identifier.
§ 801.45 Devices that must be directly marked with a unique device identifier.
§ 801.50 Labeling requirements for stand-alone software.
§ 801.55 Request for an exception from or alternative to a unique device identifier requirement.
§ 801.57 Discontinuation of legacy FDA identification numbers assigned to devices.

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

§ 321 - Definitions; generally

§ 342 - Adulterated food

§ 343 - Misbranded food

§ 351 - Adulterated drugs and devices

§ 352 - Misbranded drugs and devices

§ 355 - New drugs

§ 360i - Records and reports on devices

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

§ 371 - Regulations and hearings

§ 374 - Inspection