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e-CFR data is current as of July 28, 2021

Title 21Chapter ISubchapter HPart 801Subpart B → §801.35

Title 21: Food and Drugs
Subpart B—Labeling Requirements for Unique Device Identification

§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]

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