Requirements for a unique device identifier.
21 C.F.R. § 830.20
in effectEffective: 2024-07-01A 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.
Source: eCFRURL: https://www.ecfr.gov/api/versioner/v1/full/2024-07-01/title-21.xmlFetched: 7/26/2026