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SMG 1410.408

FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY

REGULATORY - MEDICAL DEVICES AND RADIOLOGICAL HEALTH

APPROVAL, DISAPPROVAL, OR WITHDRAWAL OF APPROVAL OF PRODUCT DEVELOPMENT PROTOCOLS AND APPLICATIONS FOR PREMARKET APPROVAL, AND HUMANITARIAN DEVICE EXEMPTIONS FOR MEDICAL DEVICES

Effective Date: 03/23/2011

[PDF Version]

1.  AUTHORITIES DELEGATED AND TO WHOM DELEGATED.

A.  The following officials, for medical devices assigned to their respective organizations, are authorized to approve, disapprove, declare as complete or incomplete, or revoke product development protocols for medical devices submitted under Section 515(f) of the Federal Food, Drug and Cosmetic Act (the Act) (21 U.S.C. 360e(f)):

1.  Director and Deputy Directors, Center for Devices and Radiological Health (CDRH); Director and Deputy Directors, Office of Device Evaluation (ODE), CDRH; Director, Program Operations Staff, ODE, CDRH; Division Directors, ODE, CDRH; Director and Deputy Directors, Office of Compliance (OC), CDRH; Division Directors, OC, CDRH; Director and Deputy Directors, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD), CDRH; Division Directors, OIVD, CDRH; and Director and Deputy Directors, Office of Surveillance and Biometrics (OSB), CDRH

2.  Director and Deputy Director, Center for Biologics Evaluation and Research (CBER); Director and Deputy Director, Office of Blood Research and Review (OBRR), CBER; Director and Deputy Director, Office of Vaccines Research and Review (OVRR), CBER; and Director and Deputy Director, Office of Cellular, Tissue and Gene Therapies (OCTGT), CBER

B.  The following officials, for medical devices assigned to their respective organizations, are authorized to approve, disapprove, or withdraw approval of applications for premarket approval for medical devices submitted under Sections 515 and 520(l) of the Act (21 U.S.C. 360e and 360j(l)):

1.  The Director and Deputy Directors, CDRH; Director and Deputy Directors, ODE, CDRH; Director, Program Operations Staff (POS), ODE, CDRH; Division Directors, ODE, CDRH; Director and Deputy Director, OC, CDRH; Division Directors, OC, CDRH; Director and Deputy Directors, OIVD, CDRH; Division Directors, OIVD, CDRH; Director and Deputy Directors, OSB, CDRH; and Division Directors, OSB, CDRH

2.  Director and Deputy Director, CBER; Director and Deputy Director, OBRR, CBER; Director and Deputy Director, OVRR, CBER; and Director and Deputy Director, OCTGT, CBER

C.  The following officials, for medical devices assigned to their respective organizations, are authorized to approve, disapprove, or withdraw approval of supplemental premarket applications:

1.  Director, POS, ODE, CDRH; Chief, Premarket Approval Section, POS, ODE, CDRH; Division Directors, ODE, CDRH; Director and Deputy Directors, OC, CDRH; Division Directors, OC, CDRH; Director and Deputy Directors, OIVD, CDRH; Division Directors, OIVD, CDRH; Director and Deputy Directors, OSB, CDRH; and Division Directors, OSB, CDRH

2.  Director and Deputy Director, CBER; Director and Deputy Director, OBRR, CBER; Director and Deputy Director, OVRR, CBER; and Director and Deputy Director, OCTGT, CBER

D.  For medical devices assigned to their organization, the following officials are authorized to issue notices to announce the approval, disapproval, or withdrawal of approval of a device, and to make publicly available a detailed summary of the information on which the decision was based, under Sections 515(d), (e), and (g) and 520(h)(1) of the Act (21 U.S.C. (d), (e), and (g) and 360j(h)(1)):

1.  Director and Deputy Directors, CDRH

2.  Director and Deputy Director, CBER; Director and Deputy Director, OBRR, CBER; Director and Deputy Director, OVRR, CBER; and Director and Deputy Director, OCTGT, CBER

E.  The following officials, for medical devices assigned to their respective organizations, are authorized to approve, disapprove, or withdraw approval of applications for humanitarian device exemption (HDE) use devices for medical devices submitted under Sections 520(m) of the Act (21 U.S.C. 360j(m)):

1.  Director and Deputy Directors, CDRH; Director and Deputy Directors, ODE, CDRH; Director, Program Operations Staff, ODE, CDRH; Division Directors, ODE, CDRH; Director and Deputy Directors, OC, CDRH; Division Directors, OC, CDRH; Director and Deputy Directors, OIVD, CDRH; and Division Directors, OIVD, CDRH

F.  The following officials, for medical devices assigned to their respective organizations, are authorized to approve, disapprove, or withdraw approval of supplemental HDE applications:

1.  Director and Deputy Directors, CDRH; Director, Program Operations Staff (POS), ODE, CDRH; Division Directors, ODE, CDRH; Chief, Investigational Device Exemption, POS, ODE, CDRH; Division Directors, ODE, CDRH; Director and Deputy Directors, OC, CDRH; Division Directors, OC, CDRH; Director and Deputy Directors, OIVD, CDRH; and Division Directors, OIVD, CDRH

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 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/OMO/DEMO/AMBMargaret A. Hamburg, M.D., Commissioner of Food and Drugs