[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR900.13]

[Page 551-552]
 
                        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 B--Quality Standards and Certification
 
Sec. 900.13  Revocation of accreditation and revocation of accreditation body approval.

    (a) FDA action following revocation of accreditation. If a 
facility's accreditation is revoked by an accreditation body, the agency 
may conduct an investigation into the reasons for the revocation. 
Following such investigation, the agency may determine that the 
facility's certificate shall no longer be in effect or the agency may 
take whatever other action or combination of actions will best protect 
the public health, including the establishment and implementation of a 
corrective plan of action that will permit the certificate to continue 
in effect while the facility seeks reaccreditation. A facility whose 
certificate is no longer in effect because it has lost its accreditation 
may not practice mammography.
    (b) Withdrawal of FDA approval of an accreditation body. (1) If FDA 
withdraws approval of an accreditation body under Sec. 900.6, the 
certificates of facilities previously accredited by such body shall 
remain in effect for up to 1 year from the date of the withdrawal of 
approval, unless FDA determines, in order to protect human health or 
because the accreditation body fraudulently accredited facilities, that 
the certificates of some or all of the facilities should be revoked or 
suspended or that a shorter time period should be established for the 
certificates to remain in effect.

[[Page 552]]

    (2) After 1 year from the date of withdrawal of approval of an 
accreditation body, or within any shorter period of time established by 
the agency, the affected facilities must obtain accreditation from 
another accreditation body, or from another entity designated by FDA.