§ 830.360 Records to be maintained by the labeler

(a) Each labeler shall retain, and submit to FDA upon specific request, records showing all unique device identifiers (UDIs) used to identify devices that must bear a UDI on their label, and the particular version or model associated with each device identifier. These records must be retained for 3 years from the date the labeler ceases to market the version or model.

(b) Compliance with this section does not relieve the labeler of the need to comply with recordkeeping requirements of any other FDA regulation.

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.

FDA guidance that cites § 830.360

• 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.

• 43 FR 32993 28 Jul 1978
• 73 FR 35341 23 Jun 2008
• 78 FR 58823 24 Sept 2013
• 86 FR 54846 5 Oct 2021