§ 5.47 - Detention of adulterated or misbranded medical devices.

The following officials are authorized to perform all the functions of the Commissioner of Food and Drugs pertaining to detention, under section 304(g) of the Federal Food, Drug, and Cosmetic Act and in accordance with § 800.55 of this chapter, of medical devices that may be adulterated or misbranded:

(a) For medical devices assigned to their respective organizations:

(1) The Director and Deputy Directors, Center for Devices and Radiological Health (CDRH).

(2) The Director and Deputy Director, Office of Compliance, CDRH.

(3) The Director and Deputy Director, Center for Biologics Evaluation and Research (CBER).

(4) The Director and Deputy Director, Office of Compliance, CBER.

(b) Regional Food and Drug Directors.

(c) District Directors.

(d) The Director, St. Louis Branch.