§ 5.408 - Determinations concerning the type of valid scientific evidence submitted in a premarket approval application.

(a) The following officials are authorized to make determinations under section 513(a)(3)(D) of the act (21 U.S.C. 360c(a)(3)(D)) concerning the type of valid scientific evidence to be submitted in a premarket approval application that will provide a reasonable assurance that a device is effective under the conditions of use proposed by such person:

(i) The Director and Deputy Directors for Science and for Regulations and Policy, CDRH.

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

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

(iv) For devices assigned to their respective Divisions: the Division Directors and Deputy Division Directors, ODE, CDRH.

(b) These officials may may not further redelegate this authority.