[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: 21CFR5.59]

[Page 53]
 
                        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. 5.59  Approval, disapproval, or withdrawal of approval of applications 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):
    (1) The Director and Deputy Directors, 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 Director, Center for Biologics 
Evaluation and Research (CBER), and the Director and Deputy Director, 
Office of Biological Product Review, 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.

[48 FR 56948, Dec. 27, 1983, as amended at 49 FR 14934, Apr. 16, 1984; 
54 FR 8318, Feb. 28, 1989; 55 FR 47053, Nov. 9, 1990; 62 FR 67272, Dec. 
24, 1997]