GroundRules
21 CFR 830.60: Relabeling of a device that is required to bear 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 830—UNIQUE DEVICE IDENTIFICATION
- Subpart B—Requirements for a Unique Device Identifier
If you relabel a device that is required to bear a unique device identifier (UDI), you must:
(a) Assign a new device identifier to the device, and
(b) Keep a record showing the relationship of the prior device identifier to your new device identifier.
Collected 2026-08-27T02:24:47Z. Source file · JSON