[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: 21CFR900.22]

[Page 586-587]
 
                        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. 900.22  Standards for certification agencies.

    The certification agency shall accept the following responsibilities 
in order to ensure quality mammography at the facilities it certifies 
and shall perform these responsibilities in a manner that ensures the 
integrity and impartiality of the certification agency's actions:
    (a) Conflict of interest. The certification agency shall establish 
and implement measures that FDA has approved in accordance with Sec. 
900.21(b) to reduce the possibility of conflict of interest or facility 
bias on the part of individuals acting on the certification agency's 
behalf.
    (b) Certification and inspection responsibilities. Mammography 
facilities shall be certified and inspected in accordance with statutory 
and regulatory requirements that are at least as stringent as those of 
MQSA and this part.
    (c) Compliance with quality standards. The scope, timeliness, 
disposition, and technical accuracy of completed inspections and related 
enforcement activities shall ensure compliance with facility quality 
standards required under Sec. 900.12.
    (d) Enforcement actions. (1) There shall be appropriate criteria and 
processes for the suspension and revocation of certificates.
    (2) There shall be prompt investigation of and appropriate 
enforcement action for facilities performing mammography without 
certificates.
    (e) Appeals. There shall be processes for facilities to appeal 
inspection findings, enforcement actions, and adverse certification 
decision or adverse accreditation decisions after exhausting appeals to 
the accreditation body.
    (f) Additional mammography review. There shall be a process for the 
certification agency to request additional mammography review from 
accreditation bodies for issues related to mammography image quality and 
clinical practice. The certification agency should request additional 
mammography review only when it believes that mammography quality at a 
facility has been compromised and may present a serious risk to human 
health.
    (g) Patient notification. There shall be processes for the 
certification agency to conduct, or cause to be conducted,

[[Page 587]]

patient notifications should the certification agency determine that 
mammography quality has been compromised to such an extent that it may 
present a serious risk to human health.
    (h) Electronic data transmission. There shall be processes to ensure 
the timeliness and accuracy of electronic transmission of inspection 
data and facility certification status information in a format and 
timeframe determined by FDA.
    (i) Changes to standards. A certification agency shall obtain FDA 
authorization for any changes it proposes to make in any standard that 
FDA has previously accepted under Sec. 900.21 before requiring 
facilities to comply with the changes as a condition of obtaining or 
maintaining certification.