[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: 21CFR5.57]

[Page 52]
 
                        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. 5.57  Temporary suspension of a medical device application.

    The following officials for medical devices assigned to their 
respective organizations are authorized under section 515(e) of the 
Federal Food, Drug, and Cosmetic Act, to determine that there is 
reasonable probability that continuation of the distribution of a device 
under an approved application would cause serious adverse health 
consequences or death, and upon making such a determination, to issue an 
order to temporarily suspend the approval of an application:
    (a) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH).
    (b) The Director and Deputy Director, Office of Compliance, CDRH.
    (c) The Director and Deputy Directors, Office of Device Evaluation, 
CDRH.
    (d) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER); the Directors of the Offices of Drug 
Evaluation I, II, III, IV, and V, Office of Review Management, CDER; the 
Director and Deputy Director, Office of Generic Drugs, Office of 
Pharmaceutical Science, CDER; and the Director and Deputy Director, 
Office of Compliance, CDER.
    (e) The Director and Deputy Director, Center for Biologics 
Evaluation and Research (CBER), and the Director and Deputy Director, 
Office of Compliance, CBER.

[56 FR 51170, Oct. 10, 1991, as amended at 57 FR 40317, Sept. 3, 1992; 
62 FR 2556, Jan. 17, 1997; 62 FR 67272, Dec. 24, 1997]