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21 CFR Part 820 · Quality Management System Regulation

§ 820.170 Installation

Subpart L - Handling, Storage, 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) Each manufacturer of a device requiring installation shall establish and maintain adequate installation and inspection instructions, and where appropriate test procedures. Instructions and procedures shall include directions for ensuring proper installation so that the device will perform as intended after installation. The manufacturer shall distribute the instructions and procedures with the device or otherwise make them available to the person(s) installing the device.

(b) The person installing the device shall ensure that the installation, inspection, and any required testing are performed in accordance with the manufacturer’s instructions and procedures and shall document the inspection and any test results to demonstrate proper installation. Subpart M—Records

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 § 820.170

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

  • Lack of or inadequate instructions 37
  • Installer records 18
  • Installer's documentation of results 3

Warning letters citing § 820.170

2 FDA warning letters since 2017 cite this section :

FDA guidance that cites § 820.170