[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR900.7]

[Page 525]
 
                        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 A--Accreditation
 
Sec. 900.7  Hearings.

    (a) Opportunities to challenge final adverse actions taken by FDA 
regarding approval or reapproval of accreditation bodies, withdrawal of 
approval of accreditation bodies, or rejection of a proposed fee for 
accreditation 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 accreditation is entitled to an 
appeals process from the accreditation body. The appeals process shall 
be specified in writing by the accreditation body and shall have been 
approved by FDA in accordance with Sec. 900.3(d) or Sec. 900.4(a)(8).
    (c) A facility that cannot achieve satisfactory resolution of an 
adverse accreditation decision through the accreditation body's appeals 
process may appeal to FDA for reconsideration in accordance with 
Sec. 900.15.