21 CFR 820.120
Device labeling
21 CFR 820.120 is the regulation titled “Device labeling” in 21 CFR Part 820, Quality System Regulation (before Feb 2, 2026). Since 2021, 8 FDA warning letters have cited it.
Part 820 changed when FDA's Quality Management System Regulation took effect on February 2, 2026. This is the earlier text these letters cite.
- Letters citing it
- 8 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 4 on the same dates in 2025
- Most often cited with
- 21 CFR 820.198, in 6 letters
- Closed out
- 13% of these letters have a published close-out
Letters citing it, by year issued
All are medical device letters. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
What FDA writes when it cites it
The finding headings that cite 21 CFR 820.120 most often, as written in the letters.
- 1 letterFailure to adequately establish procedures for the control of labeling operations to ensure that the label and labeling used for each production unit, lot, or batch is documented in the Device History Record (DHR), as…
- 1 letterFailure to develop, maintain, and implement written labeling procedures to control UDI labeling activities pursuant to 21 CFR 820.120
- 1 letterFailure to establish and maintain acceptance procedures to control labeling activities, as required by 21 CFR 820.120. Specifically, your firm has yet to establish procedures to control labeling activities for the…
The regulation
Read the text of 21 CFR 820.120 (eCFR, as of Jun 1, 2025)
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]
Text from eCFR as of Jun 1, 2025.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 820.120.
- 21 CFR 820.198Complaint files6 letters cite both
- 21 CFR 820.30Design controls6 letters cite both
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?5 letters cite both
- 21 CFR 820.184Device history record5 letters cite both
- 21 CFR 803.50If I am a manufacturer, what reporting requirements apply to me?4 letters cite both
- 21 CFR 820.100Corrective and preventive action4 letters cite both
- 21 CFR 820.80Receiving, in-process, and finished device acceptance4 letters cite both
- 21 CFR 803.18What are the requirements for establishing and maintaining MDR files or records that apply to me?3 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 820.120 that FDA posted most recently.
- DevicesView LEVO AGLEVO C3; LEVO Combi; LEVO LAE; and LEVO LCEV, Class II Standup WheelchairsIssuedJul 18, 2025PostedOct 21, 2025
- DevicesView Leltek Inc.Ultrasound Imaging System LU700 Series and Ultrasound Imaging System LK128 SeriesIssuedJul 17, 2025PostedJul 22, 2025
- DevicesView DFI Co., Ltd.CYBOW 11 Reagent Strips for UrinalysisIssuedMay 6, 2025PostedJun 3, 2025
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Counts include every citation in a letter, as the Letters filter does. How this database is built.