[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR5.49]

[Page 49]
 
                        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 B--Redelegations of Authority from the Commissioner of Food and 
                                  Drugs
 
Sec. 5.49  Authorization to use alternative evidence for determination of the effectiveness of medical devices.

    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) 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:
    (a) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH), and the Director and Deputy Directors, 
Office of Device Evaluation, CDRH.
    (b) The Director and Deputy Director, Center for Biologics 
Evaluation and Research (CBER), and the Director and Deputy Director, 
Office of Biological Product Review, CBER.

[48 FR 56947, Dec. 27, 1983, as amended at 49 FR 14933, Apr. 16, 1984; 
54 FR 8317, Feb. 28, 1989; 62 FR 67271, Dec. 24, 1997]