Jan. 18, 2024

The U.S. Food and Drug Administration (FDA) posted a new information document to assist mammography facilities subject to the Mammography Quality Standards Act (MQSA) final rule. Amended MQSA regulations take effect Sept. 10.

The FDA document highlights the new requirements in the rule, including breast density reporting, other new requirements imposed by the final rule, and additional items MQSA inspectors will look for during annual inspections. It also describes new requirements for: mammography reports; patient lay summaries; communication of results; medical outcomes audits; equipment; personnel records; medical recordkeeping; transfer of records/release of copies; facility responsibility to self-referred patients and accreditation failures.

The document provides links to subscribe to the MQSA listserv to receive email updates when new information about the topic is posted. Questions can be directed to the MQSA Hotline at MQSAhotline@versatechinc.com or 800-838-7715.


Related ACR News

  • ACR Highlights Imaging Payment Changes in HOPPS Final Rule

    ACR outlines key radiology updates in CMS 2026 HOPPS final rule, including payment changes and quality reporting updates effective Jan. 1.

    Read more
  • ACR Provides Input to FDA on AI Measurement and Evaluation

    ACR submitted comments to FDA on real-world AI device performance, stressing safety, governance, and continuous monitoring.

    Read more
  • Radiology’s Fight Against Prior Authorization Delays

    ACR is leading national efforts to make prior authorization more efficient and clinically appropriate while reducing the administrative burden and supporting national legislation.

    Read more