Mammography Quality Standards Act and Program
On March 10, 2023, the FDA issued the Final Rule to Amend the MQSA Regulations. These updated requirements are to be implemented within 18 months after publication in the Federal Register. As noted in the final rule, the FDA concluded that 18 months was a practical timeframe for facilities to implement these requirements without undue hardship. Facilities are not precluded from including the required breast density notification prior to 18 months; however, facilities subject to MQSA must comply with all the requirements, including the breast density notification, no later than September 10, 2024. The information on this webpage will be updated further when the amended MQSA regulations go into effect.
Update: The guidance “Enforcement Policy for the Quality Standards of the Mammography Quality Standards Act During the COVID-19 Public Health Emergency” has expired. (5/12/2023)
On March 13, 2023, the Food and Drug Administration (FDA) issued a Federal Register Notice, Guidance Documents Related to Coronavirus Disease 2019 (COVID-19), intended to provide clarity to stakeholders regarding the status of COVID-19 guidance documents issued by the FDA during the COVID-19 public health emergency (PHE) declared under section 319 of the Public Health Service Act (PHS Act). On May 11, 2023, the COVID-19 PHE expired. The guidance “Enforcement Policy for the Quality Standards of the Mammography Quality Standards Act During the COVID-19 Public Health Emergency” is one of the FDA-issued guidance documents that expired at the end of the day on May 11, 2023. For information on viewing expired or withdrawn guidances, see Archived Guidances.
Emergency Information
- The latest information on the ransomware attack from the Department of Homeland Security
- Tips for Mammography Facilities Following Natural Disasters or Severe Weather Conditions
What's New
- MQSA National Statistics (10/4/23)
- Mammography Facility Adverse Event and Action Report – August 22, 2023: Phelps Memorial Health Center (8/22/23)
- Mammography Facility Adverse Event and Action Report – April 25, 2023: University Park OBGYN, LLC (4/25/23)
- FDA Updates Mammography Regulations to Require Reporting of Breast Density Information and Enhance Facility Oversight (3/9/23)
- Mammography Facility Adverse Event and Action Report – February 7, 2023: Advanced Women Imaging (2/7/23)
- Mammography Facilities with Revoked MQSA Certificate (Advanced Women Imaging 02-07-23) (2/7/23)
- Updated: Mammography Problems at Advanced Women Imaging in Guttenberg, NJ (2/7/23)
Resources For You
- Digital Accreditation
- Mammography Safety Notification
- Reports (MQSA)
- Policy Guidance Help System
- Contact the MQSA Program