Regulation 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:
(c) Use only characters and numbers from the invariant character set of ISO/IEC 646, which is incorporated by reference at § 830.10 .
(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 .
Authority
21 U.S.C. 321,331,352,353,360,360d,360i,360j,371.
Related Guidelines (4)
Unique Device Identification System: Small Entity Compliance Guide: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
→Unique Device Identification: Direct Marking of Devices : Guidance for Industry and Food and Drug Administration Staff (Status: Final)
→Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI): Guidance for Industry and Food and Drug Administration Staff (Status: Final)
→Unique Device Identifier Requirements for Combination Products: Draft Guidance for Industry (Status: Draft)
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