StacksVerified U.S. regulatory reference

21 CFR §830.20

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
A unique device identifier (UDI) must:
  1. (a)Be issued under a system operated by FDA or an FDA-accredited issuing agency;
  2. (b)Conform to each of the following international standards:
    1. (1)ISO/IEC 15459-2, which is incorporated by reference at § 830.10;
    2. (2)ISO/IEC 15459-4, which is incorporated by reference at § 830.10; and
    3. (3)ISO/IEC 15459-6, which is incorporated by reference at § 830.10.
  3. (c)Use only characters and numbers from the invariant character set of ISO/IEC 646, which is incorporated by reference at § 830.10.