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SMG 1410.414

FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY

REGULATORY - MEDICAL DEVICES AND RADIOLOGICAL HEALTH

APPROVAL, DISAPPROVAL, OR WITHDRAWAL OF APPROVAL OF APPLICATIONS AND ENTERING INTO AGREEMENTS FOR INVESTIGATIONAL DEVICE EXEMPTIONS

Effective Date: 04/01/2011

[PDF Version]

1.  AUTHORITIES DELEGATED AND TO WHOM DELEGATED.

A.  For medical devices assigned to their respective organizations, the following officials are authorized to approve, disapprove, or withdraw approval of applications for investigational device exemptions submitted under Section 520(g) of the Federal Food, Drug, and Cosmetic Act (the Act) ( 21 U.S.C. 360j(g)).

1.  Center for Devices and Radiological Health (CDRH):

a.  Director and Deputy Directors, CDRH

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

c.  Director, Program Operations Staff (POS), ODE, CDRH

d.  Chief Investigational Device Exemption Section, ODE, CDRH

e.  Director and Deputy Directors, Office of Compliance (OC), CDRH

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

2.  Center for Biologics Evaluation and Research (CBER):

a.  Director and Deputy Director, CBER

b.  Director and Deputy Director, Office of Blood Research and Review (OBRR), CBER

c.  Director and Deputy Director, Office of Vaccines Research and Review (OVRR), CBER

d.  Director and Deputy Director, Office of Cellular, Tissue and Gene Therapies (OCTGT), CBER

3.  Center for Drug Evaluation and Research (CDER):

a.  Director and Deputy Directors, CDER

b.  Director and Deputy Director, Office of New Drugs (OND), CDER

B.  For medical devices assigned to their respective divisions, the following officials are authorized to approve, disapprove, or withdraw approval of applications for investigational device exemptions submitted under Section 520(g) of the Act (21 U.S.C. 360j(g)):

1.  Division Directors, ODE, CDRH

2.  Division Directors, OC, CDRH

3.  Division Directors, OIVD, CDRH

C.  For medical devices assigned to their respective organizations, the following officials are authorized to enter into written agreements concerning investigational device exemption protocols under Section 520(g)(7) of the Act (21 U.S.C. 360j(g)(7)):

1.  Center for Devices and Radiological Health (CDRH):

a.  Director and Deputy Directors, CDRH

b.  Director and Deputy Directors, ODE, CDRH

c.  Director, Program Operations Staff (POS), ODE, CDRH

d.  Chief, Investigational Device Exemption Section, POS, ODE, CDRH

e.  For medical devices assigned to their respective divisions: Division Directors and Deputy Division Directors, ODE, CDRH

f.  Director and Deputy Directors, OIVD, CDRH, and for devices assigned to their respective Division Directors and Deputy Division Directors, OIVD, CDRH

2.  Center for Biologics Evaluation and Research (CBER):

a.  Director and Deputy Director, CBER

b.  Director and Deputy Director, OBRR, CBER

c.  Director and Deputy Director, OVRR, CBER

d.  Director and Deputy Director, OCTGT, CBER

3.  Center for Drug Evaluation and Research (CDER):

a.  Director and Deputy Directors, CDER

b.  Director and Deputy Director, OND, CDER

D.  For medical devices assigned to their respective organizations, under their jurisdiction, the following officials are authorized to make decisions under 520(g)(7) of the Act (21 U.S.C. 360j(g)(7)) with respect to an agreement on an investigational plan, that a substantial scientific issue essential to determining the safety and effectiveness of the device involved has been identified:

1.  Center for Devices and Radiological Health (CDRH):

a.  Director and Deputy Directors, CDRH

b.  Director and Deputy Directors, ODE, CDRH

c.  Director and Deputy Directors, OIVD, CDRH

2.  Center for Biologics Evaluation and Research (CBER):

a.  Director and Deputy Director, CBER

b.  Director and Deputy Director, OBRR, CBER

c.  Director and Deputy Director, OVRR, CBER

d.  Director and Deputy Director, OCTGT, CBER

3.  Center for Drug Evaluation and Research (CDER):

a.  Director and Deputy Directors, CDER

b.  Director and Deputy Director, OND, CDER

2.  REDELEGATION.

These officials may not further redelegate these authorities.

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
Initial06/23/2011N/aOC/OO/OM/OMPCommissioner of Food and Drugs
Revision04/01/2011N/aCDRH/OMO/DEMO/AMBMargaret A. Hamburg, M.D., Commissioner of Food and Drugs