Pure Global AI
FDA 21

21 CFR Part 801

Labeling
United StatesFDALabeling
What this code is

21 CFR Part 801 is the official FDA identifier for “Labeling”. 21 CFR Part 801 is the official identifier FDA uses for this instrument.

Instrument
21
Full name
21 CFR Part 801
Category
Labeling
Source links
Authority source
English
Issuing-authority publication; confirm whether a later amendment or consolidated version applies.
Readable HTML
38 articles · 1 language version
Direct citations can link to a specific article or section by appending its fragment identifier.
Dates
Published
Effective
Readable full text

Open a language version

Each version has stable article anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.

About this regulation

Labeling

Current eCFR Part 801 labeling requirements for medical devices.

21 CFR Part 801 is the official identifier FDA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.