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Mammography Quality Standards Act and Program

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On March 10, 2023, the FDA issued the Final Rule to Amend the MQSA Regulations. These updated requirements are to be implemented by mammography facilities within 18 months after publication in the Federal Register. Facilities are not prohibited from including the required breast density notification prior to 18 months; however, facilities subject to the MQSA must comply with all the requirements, including the breast density notification, no later than September 10, 2024.

On January 12, 2024, the Division of Mammography Quality Standards posted "Important Information: Final Rule to Amend the Mammography Quality Standards Act (MQSA)" to assist facilities in preparing for annual MQSA inspections and to provide additional information regarding the rule amendments. The information on this webpage will be updated as additional information becomes available.

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