§ 5.413 - Approval, disapproval, or withdrawal of approval of applications and entering into agreements for investigational device exemptions.

(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 Directors for Science and for Regulations and Policy, Center for Devices and Radiological Health (CDRH), the Director and Deputy Directors, Office of Device Evaluation, CDRH, and the Director and Deputy Director, Office of Compliance, 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 Therapeutics Research and Review (OTRR), CBER.

(b) For medical devices assigned to their respective divisions, the Division Directors, Office of Device Evaluation, 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) 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 Directors for Science and for Regulations and Policy, CDRH.

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

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

(4) The Chief, Investigational Device Exemption Section, 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 Directors, CBER, and the Director and Deputy Directors of the OBRR, OVRR, and OTRR, CBER.

(d) 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 Directors, CBER, and the Director and Deputy Directors of the OBRR, OVRR, and OTRR, CBER, 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.

(e) These officials may not further redelegate these authorities.