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SMG 1410.410

FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY

REGULATORY - MEDICAL DEVICES AND RADIOLOGICAL HEALTH

DETERMINATIONS THAT MEDICAL DEVICES PRESENT
UNREASONABLE RISK OF SUBSTANTIAL HARM

Effective Date: 03/23/2011

[PDF Version]

1. AUTHORITY DELEGATED AND TO WHOM DELEGATED.

The following officials, for medical devices assigned to their respective organizations, are authorized to determine that medical devices present an unreasonable risk of substantial harm to the public health, and to order adequate notification thereof, under Section 518(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360h(a)):

1.  Director and Deputy Directors, Center for Devices and Radiological Health (CDRH); Director and Deputy Directors, Office of Device Evaluation, CDRH; Director and Deputy Directors, Office of Compliance, CDRH; and Director and Deputy Directors, Office of In Vitro Diagnostic Devices Evaluation and Safety, CDRH

2.  Director and Deputy Director, Center for Biologics Evaluation and Research (CBER); and Director and Deputy Director, Office of Compliance and Biologics Quality, CBER

3.  Director and Deputy Directors, Center for Drug Evaluation and Research (CDER); Director, Office of New Drugs, CDER; Director, Office of Pharmaceutical Science, CDER; and Director and Deputy Director, Office of Compliance, 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 March 23, 2011.

STATUS (I, R, C)DATE APPROVEDLOCATION OF CHANGE HISTORYCONTACTAPPROVING OFFICIAL
Initial06/23/2009N/aOC/OO/OM/OMPCommissioner of Food and Drugs
Revision03/23/2011N/aCDRH/OMP/DEMO/AMBMargaret A. Hamburg, M.D., Commissioner of Food and Drugs