CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 8]

[CITE: 21CFR830.100]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H - MEDICAL DEVICES

PART 830 -- UNIQUE DEVICE IDENTIFICATION

Subpart C - FDA Accreditation of an Issuing Agency

Sec. 830.100 FDA accreditation of an issuing agency.

(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.