21 CFR 820.184
Device history record
21 CFR 820.184 is the regulation titled “Device history record” in 21 CFR Part 820, Quality System Regulation (before Feb 2, 2026). Since 2021, 26 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
- 26 since 2021
- Jan 1 to Oct 30, 2026
- 2 against 7 on the same dates in 2025
- Most often cited with
- 21 CFR 820.30, in 24 letters
- Closed out
- 23% of these letters have a published close-out
Letters citing it, by year issued
Most are medical device letters (25 of 26). 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 820.184 most often, as written in the letters.
- 1 letterFailure to adequately ensure Design History Records (DHRs) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part, as…
- 1 letterFailure to adequately establish a procedure to ensure DHRs are maintained to demonstrate the device is manufactured in accordance with the DMR, per the requirements of 21 CFR Part 820.184
- 1 letterFailure to adequately establish and maintain procedures to ensure that device history records (DHR) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR…
The regulation
Read the text of 21 CFR 820.184 (eCFR, as of Jun 1, 2025)
Each manufacturer shall maintain device history records (DHR's). Each manufacturer shall establish and maintain procedures to ensure that DHR's for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part. The DHR shall include, or refer to the location of, the following information:
(a) The dates of manufacture;
(b) The quantity manufactured;
(c) The quantity released for distribution;
(d) The acceptance records which demonstrate the device is manufactured in accordance with the DMR;
(e) The primary identification label and labeling used for each production unit; and
(f) Any unique device identifier (UDI) or universal product code (UPC), and any other device identification(s) and control number(s) used.
[61 FR 52654, Oct. 7, 1996, as amended at 78 FR 58822, Sept. 24, 2013]
Text from eCFR as of Jun 1, 2025.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 820.184.
- 21 CFR 820.30Design controls24 letters cite both
- 21 CFR 820.198Complaint files19 letters cite both
- 21 CFR 820.100Corrective and preventive action16 letters cite both
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?15 letters cite both
- 21 CFR 807.81When a premarket notification submission is required14 letters cite both
- 21 CFR 820.22Quality audit11 letters cite both
- 21 CFR 820.80Receiving, in-process, and finished device acceptance11 letters cite both
- 21 CFR 803.50If I am a manufacturer, what reporting requirements apply to me?9 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 820.184 that FDA posted most recently.
- DevicesView Peter Schiff Enterprisescardiac electrode pads and AC cardiac fibrillatorsIssuedAug 26, 2026PostedOct 27, 2026
- DevicesView BlephEx, LLCBlephEx Powered Eyelid Cleaning Sponge, OptiVize Ophthalmic Battery-Powered Electrolysis Unit, OptiVize Ophthalmic ForcepsIssuedJun 3, 2026PostedJul 7, 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.