21 C.F.R. § 801.35
Voluntary labeling of a device with a unique device identifier.
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.