[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: 21CFR5.400]

[Page 76]
 
                        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. 5.400  Issuance of Federal Register documents to recognize or to 


withdraw recognition of a standard to meet premarket submission 
requirements.

    (a) The Director and Deputy Directors for Science and for 
Regulations and Policy, Center for Devices and Radiological Health; and 
the Director and Deputy Directors, Center for Biologics Evaluation and 
Research, are authorized to issue Federal Register documents under 
section 514(c) of the Federal Food, Drug, and Cosmetic Act (the act) (21 
U.S.C. 360d(c)) recognizing or withdrawing recognition of a standard for 
which a person may submit a declaration of conformity in order to meet a 
premarket submission requirement.
    (b) These officials may not further redelegate this authority.