§801.35. Voluntary labeling of a device with a unique device identifier.
21 C.F.R. § 801.35
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.
A device may bear both a Universal Product Code (UPC) and a UDI on its label and packages.
Notes, amendments, and revision history
Amendments
[78 FR 58818, Sept. 24, 2013]
Authority
Authority: 21 U.S.C. 321, 331-334, 351, 352, 360d, 360i, 360j, 371, 374.
Source
Source: 41 FR 6896, Feb. 13, 1976, unless otherwise noted.
Amendments
[78 FR 58818, Sept. 24, 2013]