[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR5.403]

[Page 57]
 
                        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. 5.403  Authorization to use alternative evidence for determination of the effectiveness of medical devices.

    (a) The following officials, for medical devices assigned to their 
respective organizations, may authorize under section 513(a)(3)(B) of 
the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 
360c(a)(3)(B)) the use of valid scientific evidence (other than that 
prescribed by section 513(a)(3)(A) of the act) for determining the 
effectiveness of medical devices for the purposes of sections 513, 514, 
and 515 of the act (21 U.S.C. 360c, 360d, and 360e):
    (1) The Director and Deputy Directors for Science and for 
Regulations and Policy, Center for Devices and Radiological Health 
(CDRH), and the Director and Deputy Directors, Office of Device 
Evaluation, CDRH.
    (2) The Director and Deputy Directors, Center for Biologics 
Evaluation and Research (CBER), and the Directors and Deputy Director, 
Office of Blood Research and Review (OBRR), Office of Vaccines Research 
and Review (OVRR), and Office of Therapeutics Research and Review 
(OTRR), CBER.
    (b) These officials may not further redelegate this authority.