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21 CFR Part 820 · Quality Management System Regulation

§ 820.130 Device packaging

Subpart K - Labeling and Packaging Control 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 ensure that device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution. Subpart L—Handling, Storage, Distribution, and Installation

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 § 820.130

Form FDA 483 observations citing this section, fiscal years 2009–2025 (Devices).

  • Packaging 28

Warning letters citing § 820.130

1 FDA warning letters since 2017 cite this section :

FDA guidance that cites § 820.130