Sign in Join the beta My account Open Compliome

21 CFR Part 820 · Quality Management System Regulation

§ 820.200 Servicing

Subpart N - Servicing 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. Servicing records now sit in § 820.35(b). See § 820.10. The text below is the former QSR wording, kept for reference.

(a) Where servicing is a specified requirement, each manufacturer shall establish and maintain instructions and procedures for performing and verifying that the servicing meets the specified requirements.

(b) Each manufacturer shall analyze service reports with appropriate statistical methodology in accordance with § 820.100.

(c) Each manufacturer who receives a service report that represents an event which must be reported to FDA under part 803 of this chapter shall automatically consider the report a complaint and shall process it in accordance with the requirements of § 820.198.

(d) Service reports shall be documented and shall include:

(1) The name of the device serviced;

(2) Any unique device identifier (UDI) or universal product code (UPC), and any other device identification(s) and control number(s) used;

(3) The date of service;

(4) The individual(s) servicing the device;

(5) The service performed; and

(6) The test and inspection data. [61 FR 52654, Oct. 7, 1996, as amended at 69 FR 11313, Mar. 10, 2004; 78 FR 58822, Sept. 24, 2013] Subpart O—Statistical Techniques

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 § 820.200

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

  • Servicing - Lack of or inadequate procedures 197
  • Service reports 71
  • Analyzing service report 31
  • Service reports/MDRs/complaints 14
  • Test and inspection data 8
  • No Service reports 5

Warning letters citing § 820.200

6 FDA warning letters since 2017 cite this section :

FDA guidance that cites § 820.200

Amendment history

Federal Register documents that created or amended this section.