(1) ISO/IEC 646:1991(E), Information technology--ISO 7-bit coded character set for information interchange (third edition;
(2) ISO/IEC 15459-2:2006(E), Information technology--Unique identifiers--Part 2: Registration procedures (second edition;
(3) ISO/IEC 15459-4:2008(E), Information technology--Unique identifiers--Part 4: Individual items (second edition;
(4) ISO/IEC 15459-6:2007(E), Information technology--Unique identifiers--Part 6: Unique identifier for product groupings (first edition;
Subpart C--FDA Accreditation of an
(a) Eligibility. A private organization may apply for accreditation as an issuing agency.
(b) Accreditation criteria.
(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
(ii) ISO/IEC 15459-4, which is incorporated by reference at
(iii) ISO/IEC 15459-6, which is incorporated by reference at
(3) Uses only characters and numbers from the invariant character set of ISO/IEC 646, which is incorporated by reference at
(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.
) Application for initial accreditation. (1) An applicant seeking initial
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