Mammography Quality Standards Act and Program

The FDA issued a Small Entity Compliance Guide to help small entities understand, in plain language, a rule issued on March 10, 2023, amending the Mammography Quality Standards Act (MQSA) and its implementing regulations (“2023 MQSA Rule”). The information contained in the SECG is also intended to replace the Policy Guidance Help System, which will be discontinued on September 10, 2024.

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 before 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

  • MQSA National Statistics (9/3/2024)
  • 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)
  • MQSA National Statistics (7/5/2023)
  • 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)
  • Updated: Mammography Problems at Advanced Women Imaging in Guttenberg, NJ (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

  • Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide
  • Policy Guidance Help System (available until September 10, 2024)
  • 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