§830.120. Responsibilities of an FDA-accredited issuing agency.

Operate a system for assignment of unique device identifiers (UDIs) that meets the requirements of § 830.20;

Make available information concerning its system for the assignment of UDIs;

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;

Upon request, provide FDA with information concerning a labeler that is employing the issuing agency's system for assignment of UDIs; and

Remain in compliance with the eligibility and accreditation criteria set forth in § 830.100.