Title 21: Food and Drugs
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/ PART 830 - UNIQUE DEVICE IDENTIFICATION
/ Subpart B - Requirements for a Unique Device Identifier / § 830.20 Requirements for a unique device identifier.
§ 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.