In observance of Breast Cancer Awareness Month, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) would like to acknowledge your important work in promoting public health.
As a reminder, the FDA issued a final rule on March 10, 2023, that amended the Mammography Quality Standards Act (MQSA) implementing regulations (“2023 MQSA Final Rule”). The new requirements of the 2023 MQSA Final Rule that amended federal standards to incorporate current science and mammography best practices are now in effect. Some highlights of the mammography requirements include:
- Categorizing Breast Tissue Density:Â Introducing four categories for reporting breast tissue density in mammography reports and two lay-language notification statements to patients.
- Enhancing Communication to Patients:Â Aiming to improve clarity and understanding of breast density information provided to patients.
- Raising the Bar for Accreditation and Facilities:Â Continuing to update the quality standards for accreditation bodies, certifying agencies, and mammography facilities.
The MQSA and its implementing regulations do not include clinical practice guidelines. The interpretation of the imaging findings remains the responsibility of the qualified interpreting physician.
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To assist mammography facilities in complying with the new regulations, the FDA developed the Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide, which includes a Q&A on facilities’ responsibilities. The guide replaces the Policy Guidance Help System, which was discontinued with the onset of the new regulations.
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