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21 CFR Part 820 · Quality Management System Regulation

§ 820.181 Device master record

Subpart M - Records Official text on eCFR
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 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.

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 § 820.181

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

  • DMR - not or inadequately maintained 794
  • DMR device specifications 64
  • DMR QA procedures and specifications 17
  • DMR production process specifications 14
  • DMR packaging and labeling specifications 3

Warning letters citing § 820.181

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

FDA guidance that cites § 820.181