[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: 21CFR900.6]

[Page 544-545]
 
                        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. 900.6  Withdrawal of approval.

    If FDA determines, through the evaluation activities of Sec. 900.5, 
or through other means, that an accreditation body is not in substantial 
compliance with this subpart, FDA may initiate the following actions:
    (a) Major deficiencies. If FDA determines that an accreditation body 
has failed to perform a major accreditation function satisfactorily, has 
demonstrated willful disregard for public health, has violated the code 
of conduct, has committed fraud, or has submitted material false 
statements to the agency, FDA may withdraw its approval of that 
accreditation body.
    (1) FDA shall notify the accreditation body of the agency's action 
and the grounds on which the approval was withdrawn.
    (2) An accreditation body that has lost its approval shall notify 
facilities accredited or seeking accreditation by it that its approval 
has been withdrawn. Such notification shall be made within a time period 
and in a manner approved by FDA.

[[Page 545]]

    (b) Minor deficiencies. If FDA determines that an accreditation body 
has demonstrated deficiencies in performing accreditation functions and 
responsibilities that are less serious or more limited than the 
deficiencies in paragraph (a) of this section, FDA shall notify the body 
that it has a specified period of time to take particular corrective 
measures directed by FDA or to submit to FDA for approval the body's own 
plan of corrective action addressing the minor deficiencies. FDA may 
place the body on probationary status for a period of time determined by 
FDA, or may withdraw approval of the body as an accreditation body if 
corrective action is not taken.
    (1) If FDA places an accreditation body on probationary status, the 
body shall notify all facilities accredited or seeking accreditation 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 body 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.
    (3) If FDA determines that an accreditation body that has been 
placed on probationary status is not implementing corrective actions 
satisfactorily or within the established schedule, FDA may withdraw 
approval of the accreditation body. The accreditation body shall notify 
all facilities accredited or seeking accreditation by it of its loss of 
FDA approval, within a time period and in a manner approved by FDA.
    (c) Reapplication by accreditation bodies that have had their 
approval withdrawn. (1) A former accreditation body that has had its 
approval withdrawn may submit a new application for approval if the body 
can provide information to FDA to establish that the problems that were 
grounds for withdrawal of approval have been resolved.
    (2) If FDA determines that the new application demonstrates that the 
body satisfactorily has addressed the causes of its previous 
unacceptable performance, FDA may reinstate approval of the 
accreditation body.
    (3) FDA may request additional information or establish additional 
conditions that must be met by a former accreditation body before FDA 
approves the reapplication.
    (4) FDA may refuse to accept an application from a former 
accreditation body whose approval was withdrawn because of fraud or 
willful disregard of public health.