801.35 Voluntary labeling of a device with a unique device identifier.§ 801.35 Voluntary labeling of a device with a unique device identifier.
(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]