21 CFR 820.40
Document controls
21 CFR 820.40 is the regulation titled “Document controls” in 21 CFR Part 820, Quality System Regulation (before Feb 2, 2026). Since 2021, 12 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, Document controls.
- Letters citing it
- 12 since 2021
- Jan 1 to Oct 30, 2026
- 1 against 3 on the same dates in 2025
- Most often cited with
- 21 CFR 820.30, in 11 letters
- Closed out
- 33% 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 820.40 most often, as written in the letters.
- 2 lettersFailure to adequately establish and maintain document control procedures, as required by 21 CFR 820.40
- 1 letterFailure to adequately establish and maintain procedures for document control as required by 21 CFR 820.40
- 1 letterFailure to adequately establish and maintain procedures to control all documents that are required by 21 CFR 820, as required by 21 CFR 820.40. For example: The Assembly Instructions, Document V065-01, for the Sentida…
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 820.40.
- 21 CFR 820.30Design controls11 letters cite both
- 21 CFR 820.198Complaint files9 letters cite both
- 21 CFR 820.100Corrective and preventive action7 letters cite both
- 21 CFR 820.50Purchasing controls7 letters cite both
- 21 CFR 820.80Receiving, in-process, and finished device acceptance7 letters cite both
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?5 letters cite both
- 21 CFR 830.300Devices subject to device identification data submission requirements5 letters cite both
- 21 CFR 801.20Label to bear a unique device identifier4 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 820.40 that FDA posted most recently.
- DevicesView Specialty Health Products CO, LLCHydro-San Colonic Irrigation System (also known as Hydro-San Plus, Hydro-San, and Hydro-San Plus A Base Unit), the Aqua Cleanse Colonic…IssuedJul 7, 2026PostedSep 22, 2026
- DevicesView LEVO AGLEVO C3; LEVO Combi; LEVO LAE; and LEVO LCEV, Class II Standup WheelchairsIssuedJul 18, 2025PostedOct 21, 2025
- DevicesView Spectra Therapy, LLCTherapeutic heating infrared lamps (LASERwrap system)IssuedJul 22, 2025PostedAug 12, 2025
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Counts include every citation in a letter, as the Letters filter does. How this database is built.