[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: 21CFR5.406]

[Page 57-58]
 
                        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. 5.406  Notification to sponsors of deficiencies in petitions for reclassification of medical devices.

    (a) The following officials, for medical devices assigned to their 
respective organizations, are authorized to notify sponsors of 
deficiencies in petitions for reclassification of medical devices 
submitted under sections 513(f) and 520(l) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360c(f) and 360j(l)):
    (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 Directors, Office of Device 
Evaluation, CDRH.
    (2) The Director and Deputy Directors, Center for Biologics 
Evaluation and Research (CBER), and the Directors and Deputy Directors 
of the Office of Blood Research and Review, Office of Vaccines Research 
and Review, and Office of Therapeutics Research and Review, CBER.

[[Page 58]]

    (b) These officials may not further redelegate this authority.