1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter H - MEDICAL DEVICES
  5. Part 801 - LABELING
  6. Subpart B - Labeling Requirements for Unique Device Identification
  7. 21 CFR § 801.35
21 CFR § 801.35
Voluntary labeling of a device with a unique device identifier
June 25, 2020
CFR

(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]

Previous
§ 801.30 General exceptions from the requirement for the label of a device to bear a unique device identifier
Next
§ 801.40 Form of a unique device identifier

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