[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR900.24]

[Page 566-567]
 
                        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. 900.24  Withdrawal of approval.

    If FDA determines, through the evaluation activities of Sec. 900.23, 
or through other means, that a certification agency is not in 
substantial compliance with this subpart, FDA may initiate the following 
actions:
    (a) Major deficiencies. If, after providing notice and opportunity 
for corrective action, FDA determines that a certification agency has 
demonstrated willful disregard for public health, has committed fraud, 
has failed to provide adequate resources for the program, has submitted 
material false statements to the agency, has failed to achieve the MQSA 
goals of quality mammography and access, or has performed or failed to 
perform a delegated function in a manner that may cause serious risk to 
human health, FDA may withdraw its approval of that certification 
agency. The certification agency shall notify, within a time period and 
in a manner approved by FDA, all facilities certified or seeking 
certification by it that it has been required to correct major 
deficiencies.
    (1) FDA shall notify the certification agency of FDA's action and 
the grounds on which the approval was withdrawn.
    (2) A certification agency that has lost its approval shall notify 
facilities certified or seeking certification by it, as well as the 
appropriate accreditation bodies with jurisdiction in the State, that 
its approval has been withdrawn. Such notification shall be made within 
a timeframe and in a manner approved by FDA.
    (b) Minor deficiencies. If FDA determines that a certification 
agency has demonstrated deficiencies in performing certification 
functions and responsibilities that are less serious or more limited 
than the deficiencies in paragraph (a) of this section, including 
failure to follow the certification agency's own procedures and policies 
as approved by FDA, FDA shall notify the certification agency that it 
has a specified period of time to take particular corrective measures as 
directed by FDA or to submit to FDA for approval the certification 
agency's own plan of corrective action addressing the minor 
deficiencies. If the approved corrective actions are not being 
implemented satisfactorily or within the established schedule, FDA may 
place the agency on probationary status for a period of time determined 
by FDA, or may withdraw approval of the certification agency.
    (1) If FDA places a certification agency on probationary status, the 
certification agency shall notify all facilities

[[Page 567]]

certified or seeking certification by it of its probationary status 
within a time period and in a manner approved by FDA.
    (2) Probationary status shall remain in effect until such time as 
the certification agency can demonstrate to the satisfaction of FDA that 
it has successfully implemented or is implementing the corrective action 
plan within the established schedule, and that the corrective actions 
have substantially eliminated all identified problems, or
    (3) If FDA determines that a certification agency that has been 
placed on probationary status is not implementing corrective actions 
satisfactorily or within the established schedule, FDA may withdraw 
approval of the certification agency. The certification agency shall 
notify all facilities certified or seeking certification by it, as well 
as the appropriate accreditation bodies with jurisdiction in the State, 
of its loss of FDA approval, within a timeframe and in a manner approved 
by FDA.
    (c) Transfer of records. A certification agency that has its 
approval withdrawn shall transfer facility records and other related 
information as required by FDA to a location and according to a schedule 
approved by FDA.