Mammography Quality Standards Act (MQSA) and MQSA Program

Tips for Mammography Facilities Following Natural Disasters or Severe Weather Conditions

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.

The FDA also issued the Small Entity Compliance Guide to assist facilities in complying with the MQSA and its implementing regulations.

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.

Subscribe to receive CDRH's Mammography email alerts and highlights as they become available.

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.
  • Apply to an FDA-approved accreditation body. 
• 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

• MQSA National Statistics (12/6/2024)
• "Approved Alternative Standard #25 – Issuing a Report with the Assessment “Incomplete: Need additional imaging evaluation” in Follow-Up to an Initial Report with the Assessment “Incomplete: Need prior mammograms for comparison.” (11/7/2024)
• Mammography Facility Adverse Event and Action Report - March 5, 2024: Desert Imaging Services (3/5/2024)
• Mammography Facility Adverse Event and Action Report - March 5, 2024: Farmbrook Radiology (3/5/2024)
• Mammography Facility Adverse Event and Action Report - March 5, 2024: Stockdale Radiology (3/5/2024)
• Important Information: Final Rule to Amend the Mammography Quality Standards Act (MQSA) (1/12/2024)
• Governmental Entity (GE) 2024 Audit announcement (12/20/2023)
• Mammography Facility Adverse Event and Action Report - August 22, 2023: Phelps Memorial Health Center (8/22/2023)
• Mammography Facility Adverse Event and Action Report - April 25, 2023: University Park OBGYN, LLC (4/25/2023)
• FDA Updates Mammography Regulations to Require Reporting of Breast Density Information and Enhance Facility Oversight (3/9/2023)
• Mammography Facility Adverse Event and Action Report - February 7, 2023: Advanced Women Imaging (2/7/2023)
• Mammography Facilities with Revoked MQSA Certificate (Advanced Women Imaging 02-07-23) (2/7/2023)

General Information for Facilities Affected by Ransomware Attacks or Natural Disasters

• The latest information on the ransomware attack from the Department of Homeland Security
• Tips for Mammography Facilities Following Natural Disasters or Severe Weather Conditions

Resources For Mammography Facilities

• Small Entity Compliance Guide 
• Contact the MQSA Program
• Appeal Options Available to Mammography Facilities Concerning Adverse Accreditation Decisions, Suspension/Revocation of Certificates, or Patient and Physician Notification Orders
• Center for Devices and Radiological Health (CDRH) Appeals Process
• Display Devices for Diagnostic Radiology
• Notification Protocols When a Facility Moves a Mammography Unit