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SMG 1410.409

FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY

REGULATORY - MEDICAL DEVICES AND RADIOLOGICAL HEALTH

DETERMINATIONS CONCERNING THE TYPE OF VALID SCIENTIFIC EVIDENCE SUBMITTED IN A PREMARKET APPROVAL APPLICATION

Effective Date: 04/01/2011

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1.  AUTHORITY DELEGATED AND TO WHOM DELEGATED.

The following officials are authorized to make determinations under Section 513(a)(3)(D) of the Federal Food, Drug, and Cosmetics Act (21 U.S.C. 360c(a)(3)(D)) concerning the type of valid scientific evidence to be submitted in a premarket approval application that will provide a reasonable assurance that a device is effective under the conditions of use proposed by such person:

1.  Director and Deputy Directors, Center for Devices and Radiological Health (CDRH)

2.  Director and Deputy Directors, Office of Device Evaluation (ODE), CDRH

3.  Director and Deputy Directors, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD), CDRH

4.  Director, Program Operations Staff, ODE, CDRH

5.  For devices assigned to their respective Divisions: Division Directors and Deputy Division Directors, ODE, CDRH

6.  For devices assigned to their respective divisions: Division Directors, Deputy Division Directors, and Associate Division Directors, OIVD, CDRH

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 April 1, 2011.

STATUS (I, R, C)DATE APPROVEDLOCATION OF CHANGE HISTORYCONTACTAPPROVING OFFICIAL
Initial06/23/2009N/aOC/OO/OM/OMPCommissioner of Food and Drugs
Revision04/01/2011N/aCDRH/OMO/DEMO/AMBMargaret A. Hamburg, M.D., Commissioner of Food and Drugs