21 CFR 820.5
Quality system
21 CFR 820.5 is the regulation titled “Quality system” in 21 CFR Part 820, Quality System Regulation (before Feb 2, 2026). Since 2021, 2 FDA warning letters have cited it.
FDA's Quality Management System Regulation reserved this section number on February 2, 2026. These letters cite the earlier Quality System Regulation section, Quality system.
- Letters citing it
- 2 since 2021
- Jan 1 to Oct 30, 2026
- 1 against 1 on the same dates in 2025
- Most often cited with
- 21 CFR 803.17, in 2 letters
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
All are medical device letters. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
What FDA writes when it cites it
The finding headings that cite 21 CFR 820.5 most often, as written in the letters.
- 2 lettersFailure to establish and maintain a quality system that is appropriate for the specific medical devices designed and manufactured as required by 21 CFR 820.5
The regulation
The text of this section is not in the saved copy.
Text from eCFR.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 820.5.
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?2 letters cite both
- 21 CFR 820.100Corrective and preventive action2 letters cite both
- 21 CFR 820.198Complaint files2 letters cite both
- 21 CFR 820.20Management responsibility2 letters cite both
- 21 CFR 820.22Quality audit2 letters cite both
- 21 CFR 820.30Design controls2 letters cite both
- 21 CFR 820.50Purchasing controls2 letters cite both
- 21 CFR 807.81When a premarket notification submission is required1 letter cites both
Latest letters citing it
The 2 letters citing 21 CFR 820.5 that FDA posted most recently.
- DevicesView Chirp Innovations, LLCChirp Halo Wireless Muscle StimulatorIssuedOct 2, 2026PostedOct 27, 2026
- DevicesView LEVO AGLEVO C3; LEVO Combi; LEVO LAE; and LEVO LCEV, Class II Standup WheelchairsIssuedJul 18, 2025PostedOct 21, 2025
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Counts include every citation in a letter, as the Letters filter does. How this database is built.