21 C.F.R. § 801.35

Voluntary labeling of a device with a unique device identifier.

Last amended: 2016Year: 2026Length: 76 wordsSubsections: 2Official source

Cite as 21 C.F.R. § 801.35 (2026)

(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. [78 FR 58818, Sept. 24, 2013]
Cross-references to the CFR
801.20.
21 C.F.R. § 801.35: Voluntary labeling of a device with a unique device identifier. | Justis AI