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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.

Welcome to the FDA's Mammography Program within the FDA’s Center for Devices and Radiological Health. The Division of Mammography Quality Standards is part of OHT8: Office of Radiological Health.

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The Mammography Quality Standards Act (MQSA) became law on Oct. 27, 1992. Congress enacted the MQSA to ensure that all people have access to quality mammography for the detection of breast cancer in its earliest, most treatable stages.

What are the Key Features of MQSA?

  • To operate lawfully, a mammography facility must be MQSA certified as providing quality mammography services.
  • For a facility to be certified, it must be accredited by a federally approved private nonprofit or State accreditation body. The FDA has approved the American College of Radiology (ACR) and the States of Arkansas and Texas as accreditation bodies. If additional States become approved, the FDA will make the appropriate announcement.
  • To be accredited, the facility must apply to an FDA-approved accreditation body; undergo periodic review of its clinical images; have an annual survey by a medical physicist; and meet federally developed quality standards for personnel qualifications, equipment, radiation dose, quality assurance programs, and recordkeeping and reporting.
  • The facility must also undergo an annual inspection conducted by federally trained and certified Federal or State personnel. 

Who Must Meet MQSA Requirements?

  • All mammography facilities that perform mammography.  (Exceptions are facilities that are under the Department of Veterans Affairs, which has developed its own mammography quality program similar to MQSA.) Requirements cover personnel, equipment, radiation dose, quality assurance programs, and recordkeeping and reporting.
  • Accreditation bodies (State or private nonprofit organizations).
  • State certification agencies
  • The following personnel:
    • Radiology technologists who perform mammographic procedures
    • Physicians who interpret mammographic images
    • Medical physicists who survey mammography equipment

What's New

General Information for Facilities Affected by Ransomware Attacks or Natural Disasters

Resources For Mammography Facilities

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