900.12(j)(1)(2): Additional mammography review and patient notification.
(1) If FDA believes that mammography quality at a facility has been compromised and may present a serious risk to human health, the facility shall provide clinical images and other relevant information, as specified by FDA, for review by the accreditation body or other entity designated by FDA. This additional mammography review will help the agency to determine whether the facility is in compliance with this section and, if not, whether there is a need to notify affected patients, their physicians, or the public that the reliability, clarity, and accuracy of interpretation of mammograms has been compromised.
(2) If FDA determines that the quality of mammography performed by a facility, whether or not certified under Sec. 900.11, was so inconsistent with the quality standards established in this section as to present a significant risk to individual or public health, FDA may require such facility to notify patients who received mammograms at such facility, and their referring physicians, of the deficiencies presenting such risk, the potential harm resulting, appropriate remedial measures, and such other relevant information as FDA may require. Such notification will occur within a timeframe and in a manner specified by FDA.
- How are additional mammography reviews (AMR) different from the reviews that are performed for accreditation, reaccreditation, or random clinical image review?
- Who can perform an AMR?
- Where is an AMR performed?
- Will the facility be responsible for patient/physician notification that may result following the AMR?