Responsibilities of an FDA-accredited issuing agency.

21 C.F.R. § 830.120
in effectEffective: 2024-07-01
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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.

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