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SMG 1410.404

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

[PDF Version]

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

2. REDELEGATION.

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 APPROVEDLOCATION OF CHANGE HISTORYCONTACTAPPROVING OFFICIAL
Initial06/23/2009N/aOC/OO/OM/OMPCommissioner of Food and Drugs
Revision02/17/2011N/aCDRH/OMO/DEMO/AMBMargaret A. Hamburg, M.D., Commissioner of Food and Drugs