[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: 21CFR5.51]

[Page 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. 5.51  Determination of classification of devices.

    (a) The following officials, for devices assigned to their 
respective organizations, are authorized to determine the classification 
of a medical device in commercial distribution prior to May 28, 1976, 
pursuant to section 513(d) of the Federal Food, Drug, and Cosmetic Act 
(the act):
    (1) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH) and the Director and Deputy Directors, Office 
of Device Evaluation, CDRH.
    (2) The Director and Deputy Director, Center for Biologics 
Evaluation and Research (CBER).
    (b) The following officials, for devices assigned to their 
respective organizations, are authorized to determine the classification 
of a medical device first intended for commercial distribution after May 
28, 1976, pursuant to section 513 (f)(1)(A) of the act:
    (1) The Director and Deputy Directors, CDRH, and the Director, 
Deputy Directors, Chief of the Premarket Notification Section, Division 
and Deputy Division Directors, Associate Division Directors, and Branch 
Chiefs, Office of Device Evaluation, CDRH.
    (2) The Director and Deputy Director, CBER.

[55 FR 6974, Feb. 27, 1990, as amended at 60 FR 2014, Jan. 6, 1995; 62 
FR 67271, Dec. 24, 1997]