subpart_subject: "FDA Accreditation of an Issuing Agency"
section_number: "830.120"
section_subject: "Responsibilities of an FDA-accredited issuing agency."
cfr_reference: "21 CFR 830.120"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 800 to 1299"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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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.