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

Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.

Warning letters citing § 830.60

1 FDA warning letters since 2017 cite this section :

• Forcemech International LLC 21 Sept 2022

FDA guidance that cites § 830.60

• Global Unique Device Identification Database (GUDID): Guidance for Industry and Food and Drug Administration Staff 17 Dec 2024
• Unique Device Identification: Direct Marking of Devices : Guidance for Industry and Food and Drug Administration Staff 17 Nov 2017

Amendment history

Federal Register documents that created or amended this section.

• 78 FR 58825 24 Sept 2013