---
kind: "section"
citation: "21 C.F.R. § 830.20"
title: "21"
number: "830.20"
heading: "Requirements for a unique device identifier."
url: "https://uscodex.org/cfr/21/830.20"
---

# §830.20. Requirements for a unique device identifier.


A unique device identifier (UDI) must:

- (a) Be issued under a system operated by FDA or an FDA-accredited issuing agency;
- (b) **Conform to each of the following international standards—**
  - (1) ISO/IEC 15459-2, which is incorporated by reference at [§ 830.10](/cfr/21/830.10.md);
  - (2) ISO/IEC 15459-4, which is incorporated by reference at [§ 830.10](/cfr/21/830.10.md); and
  - (3) ISO/IEC 15459-6, which is incorporated by reference at [§ 830.10](/cfr/21/830.10.md).
- (c) Use only characters and numbers from the invariant character set of ISO/IEC 646, which is incorporated by reference at [§ 830.10](/cfr/21/830.10.md).

## Notes

### Amendments

[78 FR 58825, Sept. 24, 2013]

### 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.

### Amendments

[78 FR 58825, Sept. 24, 2013]