§ 5.52 - Notification to sponsors of deficiencies in petitions for reclassification of medical devices.

The following officials, for medical devices assigned to their respective organizations, are authorized to notify sponsors of deficiencies in petitions for reclassification of medical devices submitted under sections 513(f) and 520(l) of the Federal Food, Drug, and Cosmetic Act:

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

(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.