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1. AUTHORITY DELEGATED AND TO WHOM DELEGATED.
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) (21 U.S.C. 360c(f) and 360 j(1)) and denials of petitions for reclassification of medical devices that are submitted under section 513(e) of the act (21 U.S.C. 360c(e)) (except for petitions submitted in response to Federal Register notices initiating standard-setting under Section 514(b) of the act (21 U.S.C. 360d(b)) or premarket approval under section 515(b) of the act (21 U.S.C. 360e(b)):
1. The Director and Deputy Director, Center for Devices and Radiological Health (CDRH) and the Director and Deputy Directors, Office of Device Evaluation, and the Director and Deputy Director, Office of In Vitro Diagnostic Devices Evaluation and Safety, CDRH.
2. The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER), and the Directors and Deputy Directors, Office of Blood Research and Review, Office of Vaccines Research and Review, and Office of Cellular, Tissue and Gene Therapies, CBER.
3. The Director and Deputy Director, Center for Drug Evaluation and Research, and the Director and Deputy Director, Office of New Drugs, CDER.
2. REDELEGATION.
These officials may not further redelegate this authority.
3. EFFECTIVE DATE.
This delegation was signed by the Commissioner on June 27, 2003.