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.