Today, the final rule to update the mammography regulations that were issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act) goes into effect. The Food and Drug Administration (FDA) issued the final rule on March 10, 2023.
Enforcement of the updated MQSA regulations (2023 MQSA Final Rule) begins today, September 10, 2024.
The MQSA Final Rule established federal standards designed to:
- Categorize Breast Tissue Density:Â Introduce four categories for reporting breast tissue density in mammography reports and two lay-language notification statements to patients.
- Enhance Communication to Patients:Â Aims to improve clarity and understanding of breast density information provided to patients.
- Raise the Bar for Accreditation and Facilities:Â Continue 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.
