FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY
REGULATORY - MEDICAL DEVICES AND RADIOLOGICAL HEALTH
AUTHORIZATION TO USE ALTERNATIVE EVIDENCE FOR DETERMINATION OF THE EFFECTIVENESS OF MEDICAL DEVICES
Effective Date: 02/17/2011
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. Director and Deputy Directors, Center for Devices and Radiological Health (CDRH); Director and Deputy Directors, Office of Device Evaluation, CDRH; and Director and Deputy Director, Office of In Vitro Diagnostic Devices Evaluation and Safety, CDRH
2. Director and Deputy Director, Center for Biologics Evaluation and Research (CBER); Directors and Deputy Director, Office of Blood Research and Review, CBER; Director and Deputy Director, Office of Vaccines Research and Review, CBER; Director and Deputy Director, Office of Cellular, Tissue and Gene Therapies, CBER
3. Director and Deputy Directors, Center for Drug Evaluation and Research (CDER); and Director and Deputy Director, Office of New Drugs, CDER
These officials may not further redelegate this authority.
3. EFFECTIVE DATE.
The Commissioner of Food and Drugs approved this delegation, via memorandum, on February 17, 2011
|STATUS (I, R, C)||DATE APPROVED||LOCATION OF CHANGE HISTORY||CONTACT||APPROVING OFFICIAL|
|Initial||06/23/2009||N/a||OC/OO/OM/OMP||Commissioner of Food and Drugs|
|Revision||02/17/2011||N/a||CDRH/OMO/DEMO/AMB||Margaret A. Hamburg, M.D., Commissioner of Food and Drugs|