January 18, 2024

FDA Document Outlines MQSA Final Rule Requirements

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.