§ 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.

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FDA guidance that cites § 801.35

• Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI): Guidance for Industry and Food and Drug Administration Staff 7 Jul 2021
• Unique Device Identification System: Small Entity Compliance Guide: Guidance for Industry and Food and Drug Administration Staff 13 Aug 2014

Amendment history

Federal Register documents that created or amended this section.

• 78 FR 58818 24 Sept 2013