21 CFR 830.120
§ 830.120 Responsibilities of an FDA-accredited issuing agency.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 830.120, § 830.120 Responsibilities of an FDA-accredited issuing agency, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88976
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Full text
To maintain its accreditation, an issuing agency must:
(a) Operate a system for assignment of unique device identifiers (UDIs) that meets the requirements of § 830.20;
(b) Make available information concerning its system for the assignment of UDIs;
(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;
(d) Upon request, provide FDA with information concerning a labeler that is employing the issuing agency's system for assignment of UDIs; and
(e) Remain in compliance with the eligibility and accreditation criteria set forth in § 830.100.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.