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1. AUTHORITY DELEGATED AND TO WHOM DELEGATED.
The following officials, for medical devices assigned to their respective organizations, may authorize under section 513(a)(3)(B) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360c(a)(3)(B)) the use of valid scientific evidence (other than that prescribed by section 513(a)(3)(A) of the act) for determining the effectiveness of medical devices for the purposes of sections 513, 514, and 515 of the act (21 U.S.C. 360c, 360d, and 360e):
1. The Director and Deputy Director, Center for Devices and Radiological Health (CDRH), Director and Deputy Directors, Office of Device Evaluation, CDRH, 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 Director, Office of Blood Research and Review (OBRR), Office of Vaccines Research and Review (OVRR), and Office of Cellular, Tissue and Gene Therapies (OCTGT), CBER.
3. The Director and Deputy Director, Center for Drug Evaluation and Research (CDER), 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.