21 CFR 830.20

§ 830.20 Requirements for a unique device identifier.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 830.20, § 830.20 Requirements for a unique device identifier, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88969
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Full text

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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.