[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: 21CFR900.5]

[Page 524]
 
                        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. 900.5  Evaluation.

    FDA shall evaluate annually the performance of each accreditation 
body. Such evaluation shall include an assessment of the reports of FDA 
or State inspections of facilities accredited by the body as well as any 
additional information deemed relevant by FDA that has been provided by 
the accreditation body or other sources or has been required by FDA as 
part of its oversight initiatives. The evaluation shall include a 
determination of whether there are major deficiencies in the 
accreditation body's performance that, if not corrected, would warrant 
withdrawal of the approval of the accreditation body under the 
provisions of Sec. 900.6.