§ 830.120. Responsibilities of an FDA-accredited issuing agency.
107 words·~1 min read·
/us/cfr/t21/s§ 830.120·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
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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§ 830.120
Responsibilities of an FDA-accredited issuing agency.
Fed. Reg.×1
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