21 CFR § 830.60 Unique Device Identification

§ 830.60 Relabeling of a device that is required to bear a unique device identifier.

Current through Sep 8, 2026 · Read all of Part 830

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.

[78 FR 58825, Sept. 24, 2013]

← § 830.50 Changes that require use of a new device identifier.§ 830.100 FDA accreditation of an issuing agency. →