21 CFR 801.35 - Voluntary labeling of a device with a unique device identifier.

Regulations last checked for updates: Feb 16, 2025

Title 21 - Food and Drugs last revised: Feb 03, 2025

View all text of Subpart B [§ 801.20 - § 801.57]

§ 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]

authority: 21 U.S.C. 321,331,351,352,360d,360i,360j,371,374

source: 41 FR 6896, Feb. 13, 1976, unless otherwise noted.

cite as: 21 CFR 801.35