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Code · CFR · Title 21 — Food and Drugs · Part 801 — Labeling · § 801.35

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

76 words·~1 min read·/us/cfr/t21/s§ 801.35·

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

(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]
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