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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 FFDCA (the Act) (21 U.S.C. 360e(f)):
1. The Director and Deputy Director, Center for Devices and Radiological Health (CDRH), the Director and Deputy Directors, Office of Device Evaluation (ODE), CDRH, the Director Program Operations Staff, ODE, CDRH, Division Directors, ODE, CDRH, and the Director and Deputy Director, Office of Compliance, (OC), CDRH, Director and Deputy Director, Office of Diagnostic Evaluation and Safety (OIVD), CDRH, and the Division Directors, OIVD, CDRH., and the Director and Deputy Director, Office of Surveillance and Biometrics (OSB), CDRH.
2. The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER), and the Director 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 (CTGT), CBER.
B.1. 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)):
a. The Director and Deputy Director, CDRH, the Director and Deputy Directors, ODE, CDRH, the Director, Program Operations Staff, ODE, CDRH, the Division Directors, ODE, CDRH, the Director and Deputy Director, OC, CDRH and the Division Directors, OC, CDRH, Director and Deputy Director, OIVD, CDRH, and the Division Directors, OIVD, CDRH, the Director and Deputy Director, OSB, CDRH, and the Division Directors, OSB, CDRH.
b. The Director and Deputy Directors, CBER, and the Directors and Deputy Directors, OBRR, OVRR, and OCTGT, CBER.
2. For medical devices assigned to their respective organizations, the Director, Program Operations Staff (POS), ODE, CDRH, the Chief, Premarket Approval Section, POS, ODE, CDRH, the Division Directors, ODE, CDRH, Director and Deputy Director, OC, CDRH, Division Directors, OC, CDRH, and the Division Directors, OIVD, CDRH, the Director and Deputy Director, OSB, CDRH, and the Division Directors, OSB, CDRH, are authorized to approve, disapprove, or withdraw approval of supplemental premarket applications.
C. The Director and Deputy Director, CDRH, for medical devices assigned to their organization, 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)).
D.1. 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)):
a. The Director and Deputy Director, CDRH, the Director and Deputy Directors, ODE, CDRH, the Director, Program Operations Staff, ODE, CDRH, the Division Directors, ODE, CDRH, the Director and Deputy Director, OC, CDRH and the Division Directors, OC, CDRH.
2. For medical devices assigned to their respective organizations, the Director, Program Operations Staff, ODE, CDRH, the Chief, Investigational Device Exemption Section, POS, ODE, CDRH, the Division Directors, ODE, CDRH, the Director and Deputy Director, Office of Compliance, CDRH and the Division Directors, OC, CDRH are authorized to approve, disapprove, or withdraw approval of supplemental HDE applications.
2. REDELEGATION.
These officials may not further redelegate these authorities.
3. EFFECTIVE DATE.
This delegation was signed by the Commissioner on August 24, 2007.