GroundRules
21 CFR 801.35: Voluntary labeling of a device with a unique device identifier.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER H—MEDICAL DEVICES
- PART 801—LABELING
- Subpart B—Labeling Requirements for Unique Device Identification
(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.
Collected 2026-08-27T02:24:47Z. Source file · JSON