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21 CFR Part 820 · Quality Management System Regulation

§ 820.25 Personnel

Subpart B - Supplemental Provisions 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.

(a) General. Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed.

(b) Training. Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented.

(1) As part of their training, personnel shall be made aware of device defects which may occur from the improper performance of their specific jobs.

(2) Personnel who perform verification and validation activities shall be made aware of defects and errors that may be encountered as part of their job functions. Subpart C—Design Controls

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 § 820.25

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

  • Training - Lack of or inadequate procedures 762
  • Training records 423
  • Personnel 135
  • Training 38
  • Sufficient personnel 5
  • Training on verification/validation defects 1

Warning letters citing § 820.25

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

FDA guidance that cites § 820.25