GroundRules
21 CFR 830.50: Changes that require use of a new 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
(a) Whenever you make a change to a device that is required to bear a unique device identifier (UDI) on its label, and the change results in a new version or model, you must assign a new device identifier to the new version or model.
(b) Whenever you create a new device package, you must assign a new device identifier to the new device package.
Collected 2026-08-27T02:24:47Z. Source file · JSON