---
kind: "section"
citation: "21 C.F.R. § 830.360"
title: "21"
number: "830.360"
heading: "Records to be maintained by the labeler."
url: "https://uscodex.org/cfr/21/830.360"
---

# §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.

## Notes

### Source

Source: 78 FR 58826, Sept. 24, 2013, unless otherwise noted.

### Authority

Authority: 21 U.S.C. 321, 331, 352, 353, 360, 360d, 360i, 360j, 371.

### Source

Source: 78 FR 58823, Sept. 24, 2013, unless otherwise noted.