GroundRules
21 CFR 830.120: Responsibilities of an FDA-accredited issuing agency.
Where this section sits in the code
- 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
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.
Collected 2026-08-27T02:24:47Z. Source file · JSON