§830.20. Requirements for a unique device identifier.

21 C.F.R. § 830.20

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.

Notes, amendments, and revision history

[78 FR 58825, Sept. 24, 2013]

Authority: 21 U.S.C. 321, 331, 352, 353, 360, 360d, 360i, 360j, 371.

Source: 78 FR 58823, Sept. 24, 2013, unless otherwise noted.

[78 FR 58825, Sept. 24, 2013]