§ 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 .

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FDA guidance that cites § 830.20

• Unique Device Identifier Requirements for Combination Products: Draft Guidance for Industry draft 25 Jun 2025
• Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI): Guidance for Industry and Food and Drug Administration Staff 7 Jul 2021
• Unique Device Identification: Direct Marking of Devices : Guidance for Industry and Food and Drug Administration Staff 17 Nov 2017
• Unique Device Identification System: Small Entity Compliance Guide: Guidance for Industry and Food and Drug Administration Staff 13 Aug 2014

Amendment history

Federal Register documents that created or amended this section.

• 78 FR 58825 24 Sept 2013