21 C.F.R. § 830.20

Current through October 31, 2024

Section 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 .

21 C.F.R. §830.20

78 FR 58825 , Sept. 24, 2013