Title 21

SECTION 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;

(2) ISO/IEC 15459-4, which is incorporated by reference at § 830.10; and

(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]