March 28, 2019

FDA Proposes Substantial Changes for MQSA Regulations

The U.S. Food and Drug Administration, in a recently-published Notice of Proposed Rulemaking, has proposed a series of amendments to regulations issued under the Mammography Quality Standards Act of 1992 (MQSA).

The proposed regulatory changes, which the FDA says will improve the quality of mammography services for millions of Americans, were summarized in a March 27, 2019 news release.

Among the proposed changes:

  • Mandatory breast density disclosure, including specified language that would explain how breast density can influence mammography accuracy and recommend a consultation between patient and provider to discuss how breast density relates to breast cancer risk and their individual situation
  • Specification of the information to be collected or evaluated during the required mammography medical outcomes audit to include positive predictive value, cancer detection rate and recall rate
  • Requirements related to the release of patient records, including specified timeframes and a requirement that transferred mammograms be in the mammographic modality in which they were produced and not produced by copying or digitizing hardcopy originals
  • Possible direct communications from the FDA to patients and providers when a mammography facility does not meet MQSA quality standards
  • A requirement that only digital accessory components specifically FDA-approved or cleared for mammography may be used, and
  • New record-keeping requirements to minimize information loss and to improve access to and transfer of patient mammography record

"Screening technology, breast imaging practices and our knowledge of breast cancer biology have advanced over the years. It is understandable that the FDA would revisit these regulations,” said Dana Smetherman, MD, chair of the American College of Radiology Breast Imaging Commission. “While breast density reporting requirements would be new at the federal level, many states now have breast density notification requirements. Radiologists are complying with those laws. The inclusion of breast density information in mammography reports to patients’ referring physicians has been in place for many years - based on the American College of Radiology BI-RADS classification system. The ACR supports providing patients and their doctors with accurate, actionable information to better diagnose and treat those in our care. We look forward to working with FDA through the details of this process to ensure that any updates to FDA regulation improve patient care and efficiency of care provided.”

Questions about the proposals may be directed to Gloria Romanelli, Senior Director Government Relations at