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21 CFR Part 820 · Quality Management System Regulation

§ 820.120 Device labeling

Subpart K - Labeling and Packaging Control 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. 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 establish and maintain procedures to control labeling activities.

(a) Label integrity. Labels shall be printed and applied so as to remain legible and affixed during the customary conditions of processing, storage, handling, distribution, and where appropriate use.

(b) Labeling inspection. Labeling shall not be released for storage or use until a designated individual(s) has examined the labeling for accuracy including, where applicable, the correct unique device identifier (UDI) or universal product code (UPC), expiration date, control number, storage instructions, handling instructions, and any additional processing instructions. The release, including the date and signature of the individual(s) performing the examination, shall be documented in the DHR.

(c) Labeling storage. Each manufacturer shall store labeling in a manner that provides proper identification and is designed to prevent mixups.

(d) Labeling operations. Each manufacturer shall control labeling and packaging operations to prevent labeling mixups. The label and labeling used for each production unit, lot, or batch shall be documented in the DHR.

(e) Control number. Where a control number is required by § 820.65, that control number shall be on or shall accompany the device through distribution. [61 FR 52654, Oct. 7, 1996, as amended at 78 FR 58822, Sept. 24, 2013]

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 § 820.120

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

  • Lack of or inadequate procedures for labeling 248
  • Records, DHR {see also 820.184(e)} 70
  • DHR documentation of label release {see also 820.184} 60
  • Examination for accuracy 34
  • Labeling inspection - UDI 24
  • Mixups 13

Warning letters citing § 820.120

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

FDA guidance that cites § 820.120

Amendment history

Federal Register documents that created or amended this section.