§ 5.50 - Notification to petitioners of determinations made on petitions for reclassification of medical devices.

The following officials, for medical devices assigned to their respective organizations, are authorized to notify petitioners of determinations made on petitions for reclassification of medical devices that are classified in class III (premarket approval) by sections 513(f) and 520(l) of the Federal Food, Drug, and Cosmetic Act (the act) and denials of petitions for reclassification of medical devices that are submitted under section 513(e) of the act (except for petitions submitted in response to Federal Register notices initiating standard-setting under section 514(b) of the act or premarket approval under section 515(b) of the act):

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

(b) The Director and Deputy Director, Center for Biologics Evaluation and Research (CBER), and the Director and Deputy Director, Office of Biological Product Review, CBER.