Section 830.20 - Requirements for a unique device identifierA 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 . 78 FR 58825 , Sept. 24, 2013