CFR /  Title 21  /  Part 830  /  Sec. 830.120 Responsibilities of an FDA-accredited issuing agency.

To maintain its accreditation, an issuing agency must:

(a) Operate a system for assignment of unique device identifiers (UDIs) that meets the requirements of Sec. 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 Sec. 830.100.