---
kind: "section"
citation: "21 C.F.R. § 830.120"
title: "21"
number: "830.120"
heading: "Responsibilities of an FDA-accredited issuing agency."
url: "https://uscodex.org/cfr/21/830.120"
---

# §830.120. Responsibilities of an FDA-accredited issuing agency.


To maintain its accreditation, an issuing agency must:

- (a) Operate a system for assignment of unique device identifiers (UDIs) that meets the requirements of [§ 830.20](/cfr/21/830.20.md);
- (b) Make available information concerning its system for the assignment of UDIs;
- (c) Maintain a list of labelers that use its system for the assignment of UDIs and provide FDA a copy of such list in electronic form by December 31 of each year;
- (d) Upon request, provide FDA with information concerning a labeler that is employing the issuing agency's system for assignment of UDIs; and
- (e) Remain in compliance with the eligibility and accreditation criteria set forth in [§ 830.100](/cfr/21/830.100.md).

## Notes

### 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.