§ 830.20 Requirements for a unique device identifier.
Current through Sep 8, 2026 · Read all of Part 830
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]