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: 21CFR830.130]

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. 830.130 Suspension or revocation of the accreditation of an issuing agency.

FDA may suspend or revoke the accreditation of an issuing agency if FDA finds, after providing the issuing agency with notice and opportunity for an informal hearing in accordance with part 16 of this chapter, that the issuing agency or any officer, employee, or other agent of the issuing agency:

(a) Has been guilty of misrepresentation or failure to disclose required information in obtaining accreditation;

(b) Has failed to fulfill the responsibilities outlined in § 830.120;

(c) Has failed to protect against conflicts of interest that may impede the issuing agency's ability to independently operate a fair and neutral identifier system;

(d) In the operation of the issuing agency, has engaged in any anticompetitive activity to restrain trade; or

(e) Has violated or aided and abetted in the violation of any regulation issued under section 510(e) or section 519(f) of the Federal Food, Drug, and Cosmetic Act.