[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR5.401]

[Page 76-77]
 
                        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. 5.401  Issuance of Federal Register documents pertaining to 
exemptions from premarket notification.

    (a) The Director and Deputy Directors for Science and for 
Regulations and Policy, Center for Devices and Radiological Health; and 
the Directors

[[Page 77]]

and Deputy Directors, Center for Biologics Evaluation and Research, are 
authorized to make determinations and issue Federal Register notices and 
rules under section 510(m) of the act (21 U.S.C. 360(m)) concerning 
exemptions from premarket notification.
    (b) These officials may not further redelegate this authority.