[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: 21CFR5.50]

[Page 49-50]
 
                        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. 5.50  Notification to petitioners of determinations made on petitions for reclassification of medical devices.

    The following officials, for medical devices assigned to their 
respective organizations, are authorized to notify petitioners of 
determinations made on petitions for reclassification of medical devices 
that are classified in class III (premarket approval) by sections 513(f) 
and 520(l) of the Federal Food, Drug, and Cosmetic Act (the act) and 
denials of petitions for reclassification of medical devices that are 
submitted under

[[Page 50]]

section 513(e) of the act (except for petitions submitted in response to 
Federal Register notices initiating standard-setting under section 
514(b) of the act or premarket approval under section 515(b) 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.
    (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; 54 FR 11866, Mar. 22, 1989; 62 FR 67271, Dec. 
24, 1997]