21 CFR 801.35
§ 801.35 Voluntary labeling of a device with a unique device identifier.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 801.35, § 801.35 Voluntary labeling of a device with a unique device identifier, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88663
- Permanent ID
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Full text
(a) The labeler of a device that is not required to bear a unique device identifier (UDI) may voluntarily comply with § 801.20. If a labeler voluntarily includes a UDI for a device, the labeler may voluntarily provide information concerning the device under subpart E of part 830 of this chapter.
(b) A device may bear both a Universal Product Code (UPC) and a UDI on its label and packages.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.