[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR5.409]

[Page 58-59]
 
                        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 F--Medical Devices and Radiological Health; Redelegations of 
                                Authority
 
Sec. 5.409  Determinations that medical devices present unreasonable risk of substantial harm.

    (a) The following officials, for medical devices assigned to their 
respective organizations, are authorized to determine that medical 
devices present an unreasonable risk of substantial harm to the public 
health, and to order adequate notification thereof, under section 518(a) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360h(a)):
    (1) The Director and Deputy Directors for Science and for 
Regulations and Policy, Center for Devices and Radiological Health 
(CDRH), and the Director and Deputy Director, Office of Compliance, 
CDRH.

[[Page 59]]

    (2) The Director and Deputy Directors, Center for Biologics 
Evaluation and Research (CBER), and the Director and Deputy Director, 
Office of Compliance and Biologics Quality, CBER.
    (3) The Director, the Deputy Director, and the Directors, Office of 
Review Management and Pharmaceutical Science, Center for Drug Evaluation 
and Research (CDER); and the Director and Deputy Director, Office of 
Compliance, CDER.
    (b) These officials may not further redelegate this authority.