[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR900.25]

[Page 558]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 900--MAMMOGRAPHY--Table of Contents
 
                     Subpart C--States as Certifiers
 
Sec. 900.25  Hearings and appeals.

    (a) Opportunities to challenge final adverse actions taken by FDA 
regarding approval of certification agencies or withdrawal of approval 
of certification agencies shall be communicated through notices of 
opportunity for informal hearings in accordance with part 16 of this 
chapter.
    (b) A facility that has been denied certification is entitled to an 
appeals process from the certification agency. The appeals process shall 
be specified in writing by the certification agency and shall have been 
approved by FDA in accordance with Secs. 900.21 and 900.22.

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