subpart_subject: "Requirements for a Unique Device Identifier"
section_number: "830.20"
section_subject: "Requirements for a unique device identifier."
cfr_reference: "21 CFR 830.20"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 800 to 1299"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
---
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.