21 CFR 820.181
Device master record
21 CFR 820.181 is the regulation titled “Device master record” in 21 CFR Part 820, Quality System Regulation (before Feb 2, 2026). Since 2021, 12 FDA warning letters have cited it.
Part 820 changed when FDA's Quality Management System Regulation took effect on February 2, 2026. This is the earlier text these letters cite.
- Letters citing it
- 12 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 2 on the same dates in 2025
- Most often cited with
- 21 CFR 820.30, in 10 letters
- Closed out
- 50% 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 820.181 most often, as written in the letters.
- 1 letterFailure to adequately maintain a device master record to include, or refer to the location of, the packaging and labeling specifications, including methods and processes used, as required by 21 CFR 820.181(d)
- 1 letterFailure to establish and maintain device master records, as required by 21 CFR 820.181
- 1 letterFailure to maintain a device master record, as required by 21 CFR 820.181. For example, your firm failed to demonstrate that the Mueller Hinton Agar was manufactured according to the Device Master Record (DMR). Your…
The regulation
Read the text of 21 CFR 820.181 (eCFR, as of Jun 1, 2025)
Each manufacturer shall maintain device master records (DMR's). Each manufacturer shall ensure that each DMR is prepared and approved in accordance with § 820.40. The DMR for each type of device shall include, or refer to the location of, the following information:
(a) Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications;
(b) Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications;
(c) Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used;
(d) Packaging and labeling specifications, including methods and processes used; and
(e) Installation, maintenance, and servicing procedures and methods.
Text from eCFR as of Jun 1, 2025.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 820.181.
- 21 CFR 820.30Design controls10 letters cite both
- 21 CFR 820.184Device history record7 letters cite both
- 21 CFR 820.198Complaint files7 letters cite both
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?6 letters cite both
- 21 CFR 820.75Process validation6 letters cite both
- 21 CFR 820.100Corrective and preventive action5 letters cite both
- 21 CFR 820.22Quality audit5 letters cite both
- 21 CFR 820.80Receiving, in-process, and finished device acceptance5 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 820.181 that FDA posted most recently.
- DevicesView LEVO AGLEVO C3; LEVO Combi; LEVO LAE; and LEVO LCEV, Class II Standup WheelchairsIssuedJul 18, 2025PostedOct 21, 2025
- DevicesView EpiCare Acquisitions, LLCEpiCare-Zenith Family of Laser SystemsIssuedMar 21, 2025PostedApr 8, 2025
- DevicesView Jiangsu Shenli Medical Production Co., Ltd.Sterile and non-sterile syringesIssuedJul 18, 2024PostedJul 18, 2024
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Counts include every citation in a letter, as the Letters filter does. How this database is built.