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Mammography Quality Standards Act (MQSA) and MQSA Program

MQSA graphic - 4 circles with photos of mammography patients and devices

UPDATES:

On September 10, 2024, the FDA updated Important Information: Final Rule to Amend the Mammography Quality Standards Act (MQSA), as facilities are now subject to all applicable MQSA requirements, including those in the 2023 MQSA Final Rule.

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

The FDA's Mammography Program is part of the Center for Devices and Radiological Health (CDRH) OHT8: Office of Radiological Health.

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What are the Key Features of MQSA?

Mammography facilities must:

  • Be MQSA certified as providing quality mammography services.
  • Be accredited by a federally approved private nonprofit or State accreditation body. If additional States become approved, the FDA will make the appropriate announcement.
  • Undergo periodic review of its clinical images (21 CFR 900.4(c))
  • Have an annual survey conducted by a medical physicist or under the direct supervision of a medical physicist (21 CFR 900.4(e) and 900.12(e)(10)), 
  • Continue to meet federally developed quality standards, including those for personnel qualifications, equipment, radiation dose, quality assurance programs, and recordkeeping and reporting (21 CFR 900.4(b) and 21 CFR 900.12).  
  • Be inspected at least annually by a certified MQSA inspector (42 U.S.C. 263b(g)(1)(E)).

FDA-approved accreditation bodies must:

  • Review a mammography facility's equipment, personnel (interpreting physicians, radiologic technologists, and medical physicists), clinical image quality, and practices. 
  • Accredit the facility if its review establishes that the mammography facility meets the federal quality standards established under the MQSA and its implementing regulations. (21 CFR 900.4).

Who Must Meet MQSA Requirements?

  • All mammography facilities must comply with these requirements, except those under the Department of Veterans Affairs.
  • Accreditation bodies (State or private nonprofit organizations)
  • State certification agencies
  • The following personnel:
    • Radiologic 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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