21 C.F.R. § 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. (1) ISO/IEC 15459-2, which is incorporated by reference at § 830.10;
2. (2) ISO/IEC 15459-4, which is incorporated by reference at § 830.10; and
3. (3) ISO/IEC 15459-6, which is incorporated by reference at § 830.10.
(c) Use only characters and numbers from the invariant character set of ISO/IEC 646, which is incorporated by reference at § 830.10.

[78 FR 58825, Sept. 24, 2013]