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FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY

REGULATORY - MEDICAL DEVICES AND RADIOLOGICAL HEALTH

1410.414 - APPROVAL, DISAPPROVAL, OR WITHDRAWAL OF APPROVAL OF APPLICATIONS AND ENTERING INTO AGREEMENTS FOR INVESTIGATIONAL DEVICE EXEMPTIONS

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. The Director and Deputy Director, Center for Devices and Radiological Health (CDRH), (CDRH), the Director and Deputy Directors, Office of Device Evaluation, CDRH, the Director, Program Operations Staff (POS), ODE, CDRH, the Chief Investigational Device Exemption Section, ODE, CDRH, the Director and Deputy Directors for Science and for Regulations and Policy, the Director and Deputy Director, Office of Compliance, CDRH, and the Director and Deputy Director, Office of In Vitro Diagnostic Devices Evaluation and Safety (OIVD), CDRH.

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

3. The Director and Deputy Director, Center for Drug Evaluation and Research (CDER), and the Director and Deputy Director, Office of New Drugs, CDER.

B. For medical devices assigned to their respective divisions, the Division Directors, ODE, CDRH, and the Division Directors, OIVD, CDRH, 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(y)).

C. For devices within their jurisdiction,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. The Director and Deputy Director, CDRH.

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

3. The Director, Program Operations Staff (POS), ODE, CDRH.

4. The Chief, Investigational Device Exemption Section, POS, ODE, CDRH.

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

6. The Director and Deputy Director, OIVD, CDRH, and for devices assigned to their respective divisions, Division Directors and Deputy Division Directors, OIVD, CDRH.

7. The Director and Deputy Directors, CBER, and the Director and Deputy Directors of the OBRR, OVRR, and OCTGT, CBER.

8. The Director and Deputy Director, CDER, and the Director and Deputy Director, Office of New Drugs, CDER.

D. For devices under their jurisdiction, the Director and Deputy Directors for Science and for Regulations and Policy, CDRH and the Director and Deputy Directors, ODE, CDRH, the Director and Deputy Director, OIVD, CDRH, the Director and Deputy Directors, CBER, the Director and Deputy Directors of the OBRR, OVRR, and OCTGT, CBER, the Director and Deputy Director, CDER, and the Director and Deputy Director, Office of New Drugs, CDER, are authorized to make decisions under section 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.

2. REDELEGATION.

These officials may not further redelegate these authorities.

3. EFFECTIVE DATE.

This delegation was signed by the Commissioner on June 27, 2003.

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