Voluntary labeling of a device with a unique device identifier.

21 C.F.R. § 801.35
in effectEffective: 2024-07-01
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(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.

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