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21 CFR Part 820 · Quality Management System Regulation

§ 820.184 Device history record

Subpart M - Records Official text on eCFR Amendment history
Removed from 21 CFR. The Quality Management System Regulation (QMSR) replaced the Quality System Regulation on 2 Feb 2026. Removed by the Quality Management System Regulation, effective 2 February 2026: Part 820 now incorporates ISO 13485:2016 by reference (§ 820.7) and requires it in § 820.10. See § 820.10. The text below is the former QSR wording, kept for reference.

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]

Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.

What FDA inspectors cite under § 820.184

Form FDA 483 observations citing this section, fiscal years 2009–2026 (Devices).

  • Lack of or inadequate DHR procedures 653
  • DHR - not or inadequately maintained 586
  • DHR content 553
  • Acceptance records 47
  • DHR - UDI not included 41
  • ID label, labeling 31

Warning letters citing § 820.184

52 FDA warning letters since 2017 cite this section ; the most recent:

FDA guidance that cites § 820.184

Amendment history

Federal Register documents that created or amended this section.