Radiation-Emitting Products

Standards for Certification Agencies

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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, 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.

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Page Last Updated: 08/11/2014
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