[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR900.23]

[Page 587]
 
                        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. 900.23  Evaluation.

    FDA shall evaluate annually the performance of each certification 
agency. The evaluation shall include the use of performance indicators 
that address the adequacy of program performance in certification, 
inspection, and enforcement activities. FDA will also consider any 
additional information deemed relevant by FDA that has been provided by 
the certification body or other sources or has been required by FDA as 
part of its oversight mandate. The evaluation also shall include a 
review of any changes in the standards or procedures in the areas listed 
in Sec. Sec. 900.21(b) and 900.22 that have taken place since the 
original application or the last evaluation, whichever is most recent. 
The evaluation shall include a determination of whether there are major 
deficiencies in the certification agency's regulations or performance 
that, if not corrected, would warrant withdrawal of the approval of the 
certification agency under the provisions of Sec. 900.24, or minor 
deficiencies that would require corrective action.