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FDA 21

21 CFR Part 820

Quality Management System Regulation
United StatesFDAGMP/QMSEffective February 2, 2026
What this code is

21 CFR Part 820 is the official FDA identifier for “Quality Management System Regulation”. 21 CFR Part 820 is the official identifier FDA uses for this instrument.

Instrument
21
Full name
21 CFR Part 820
Category
GMP/QMS
Source links
Authority source
English
Issuing-authority publication; confirm whether a later amendment or consolidated version applies.
Readable HTML
9 articles · 1 language version
Direct citations can link to a specific article or section by appending its fragment identifier.
Dates
Published
February 2, 2024
Effective
February 2, 2026
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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

Quality Management System Regulation

Current eCFR Part 820 Quality Management System Regulation. Official XML ingested from the eCFR versioner using the title 21 up-to-date-as-of date, not ingest time.

21 CFR Part 820 is the official identifier FDA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.