June 13, 2019

MQSA Proposed Rule Changes

The Food and Drug Administration (FDA) is proposing to update mammography regulations issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act. The proposal is aimed at modernizing regulations to improve the delivery of mammography services by:

  • Strengthening the communication of healthcare information
  • Allowing for more informed decision making by patients and providers
  • Helping to ensure the availability of qualified mammography personnel
  • Bolstering the medical outcomes audit to provide feedback to improve mammography interpretations
  • Modernizing technological aspects of the standards
  • Adding additional tools to address facility compliance issues

Among other updates, the FDA is proposing changes to:

  • Dense breast imaging
  • Rules for handling personnel records
  • Equipment updates
  • Accreditation requirements

Proposed Effective Date

The FDA proposes that any final rule that may issued based on this proposal become effective 18 months after the date of publication of the final rule in the Federal Register. Facilities need time to become familiar with new requirements and to add breast density reporting to their reporting systems.

Review Comments

The ACR Government Relations Department and the leaders of our various breast imaging committees/commissions have reviewed the proposed rule and will submit comments about how the changes could impact patients, providers and hospitals. You can review all comments on the proposed changes or submit your own by June 26, 2019.