Section 830.120 - Responsibilities of an FDA-accredited issuing agencyTo 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 .