[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR5.408]

[Page 58]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 5--DELEGATIONS OF AUTHORITY AND ORGANIZATION--Table of Contents
 
  Subpart F--Medical Devices and Radiological Health; Redelegations of 
                                Authority
 
Sec. 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.