§ 830.100. FDA accreditation of an issuing agency.
185 words·~1 min read·
/us/cfr/t21/s§ 830.100·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Eligibility. A private organization may apply for accreditation as an issuing agency.
(b)Accreditation criteria. FDA may accredit an organization as an issuing agency, if the system it will operate:
(1)Will employ unique device identifiers
(UDIs)that meet the requirements of this part to adequately identify a device through its distribution and use;
(2)Conforms to each of the following international standards:
(i)ISO/IEC 15459-2, which is incorporated by reference at § 830.10;
(ii)ISO/IEC 15459-4, which is incorporated by reference at § 830.10;
(iii)ISO/IEC 15459-6, which is incorporated by reference at § 830.10.
(3)Uses only characters and numbers from the invariant character set of ISO/IEC 646, which is incorporated by reference at § 830.10.
(4)Will be available to all users according to a single set of consistent, fair, and reasonable terms and conditions.
(5)Will protect against conflicts of interest between the issuing agency (and its officers, employees, and other agents) and labelers (and their officers, employees, and other agents) seeking to use UDIs that may impede the applicant's ability to independently operate a fair and neutral identifier system.