StacksVerified U.S. regulatory reference

21 CFR §830.120

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
To maintain its accreditation, an issuing agency must:
  1. (a)Operate a system for assignment of unique device identifiers (UDIs) that meets the requirements of § 830.20;
  2. (b)Make available information concerning its system for the assignment of UDIs;
  3. (c)Maintain a list of labelers that use its system for the assignment of UDIs and provide FDA a copy of such list in electronic form by December 31 of each year;
  4. (d)Upon request, provide FDA with information concerning a labeler that is employing the issuing agency's system for assignment of UDIs; and
  5. (e)Remain in compliance with the eligibility and accreditation criteria set forth in § 830.100.