FDA Releases Final Guidance For MQSA Regulation Changes Effective Sept. 10

The U.S. Food and Drug Administration (FDA) this week provided notice of final guidance issued by the Center for Devices and Radiological Health, Mammography Quality Standards Act (MQSA) and Regulation Amendments: Small Entity Compliance Guide (SECG). The FDA developed the SECG to explain the actions a small entity must take to comply with the MQSA rule and its implementing regulations.

The March 2023 MQSA rule modernized mammography regulations and specifies that the mammography report given to patients specifies if they have dense or non-dense breast tissue; it includes a prescribed paragraph on the significance of breast density.

The FDA prepared the SECG to help small entities comply with MQSA regulation changes, which take effect Sept. 10.

For more information, contact Katie Grady, American College of Radiology® Government Affairs Director.

Related ACR News

HRSA Breast Cancer Screening for Average Risk Guideline
The U.S. Department of Health and Human Services Health Resources and Services Administration finalized its proposal for the Breast Cancer Screening for Women at Average Risk guideline.
Read more
ACR Comments on Draft HRSA Breast Cancer Screening Recommendations
The American College of Radiology® (ACR®) submitted comments this week on draft recommendations for the Health Resources and Services Administration (HRSA)-supported Women's Preventive Services Guidelines , including for breast cancer screening.
Read more
Navigating Breast Imaging Guidelines
In April 2024, the U.S. Preventive Services Task Force changed the recommendations for imaging of non–BRCA-related breast cancer. The recommendations now state that biennial screening mammography is recommended for women ages 40 to 74, a pattern formerly suggested for women at least 50 years old.
Read more