Federal Law Overview

In March 2023, the U.S. Food and Drug Administration (FDA) finalized a nationwide amendment to the Mammography Quality Standards Act (MQSA). This federal law mandates that, beginning September 10, 2024, all mammography facilities must notify patients in writing about their breast density after a mammogram.

Prior to this federal standard, 38 states and Washington, D.C. had their own laws, leading to inconsistent patient notifications. This amendment ensures consistent federal language for all women in the U.S. Although the intent of the law was to improve patient awareness and promote better education about the risks associated with dense breast tissue, it still leaves significant gaps. The law does not require full clarity on specific risk levels, nor does it mandate a standardized education process across all clinics.

Both imaging providers and physicians have a shared responsibility to help women fully understand what dense tissue means — and how it impacts their screening and risk management.