The U.S. Food and Drug Administration (FDA) is proposing to amend its regulations governing mammography to include breast density reporting, the agency stated in the Federal Register.
The FDA is proposing to add a breast density reporting amendment to the Mammography Quality Standards Act (MQSA), which would mean that women would receive standardized nationwide notification about their breast tissue density after their mammograms. The FDA said it would consider the proposed rule in December 2013.
In addition to breast density notification, the amendments would update MQSA regulations to address changes in mammography technology and processes that have occurred since the regulations were last published in 1997.











![A normal mammogram confirmed by three-year radiologic follow-up illustrates reader-marked regions of interest (ROIs) during (A) unaided (round 1) and (B) artificial intelligence (AI)–assisted (round 2) reading. Each colored dot represents an ROI for recall by a human reader. Readers could mark more than one ROI per case, represented by multiple dots of the same color. During AI-assisted reading, the AI system displayed three visible prompts: two with suspicion of malignancy scores of 35% (left mediolateral oblique [L MLO] and craniocaudal [L CC]) and one with a suspicion of malignancy score of 10% (right craniocaudal [R CC]), shown as polygonal overlays. Without AI, six of 10 readers (60%) marked a false-positive ROI. With AI assistance, this fell to two of 10 (20%). R MLO = right mediolateral oblique.](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/07/2026-07-14-radiology-mammogram-ai-auto-bias.H0bYO8QlWs.jpg?auto=format%2Ccompress&fit=crop&h=112&q=70&w=112)






