§ 5.51 - Determination of classification of devices.

(a) The following officials, for devices assigned to their respective organizations, are authorized to determine the classification of a medical device in commercial distribution prior to May 28, 1976, pursuant to section 513(d) of the Federal Food, Drug, and Cosmetic Act (the act):

(1) The Director and Deputy Directors, Center for Devices and Radiological Health (CDRH) and the Director and Deputy Directors, Office of Device Evaluation, CDRH.

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

(b) The following officials, for devices assigned to their respective organizations, are authorized to determine the classification of a medical device first intended for commercial distribution after May 28, 1976, pursuant to section 513 (f)(1)(A) of the act:

(1) The Director and Deputy Directors, CDRH, and the Director, Deputy Directors, Chief of the Premarket Notification Section, Division and Deputy Division Directors, Associate Division Directors, and Branch Chiefs, Office of Device Evaluation, CDRH.

(2) The Director and Deputy Director, CBER.