After a long wait, the FDA issued a final rule that adds details on breast density reporting to the Mammography Quality Standards Act. The rule takes effect in September 2024 and should go a long way toward clarifying the issue of breast density for patients.
Breast tissue density is a risk factor for cancer, and dense breast tissue can make it more difficult for radiologists to identify tumors on conventional x-ray mammography. This shortcoming is often not communicated to women who receive “normal” mammograms, but later find out that a cancer was missed.
Prodded by a strong patient advocacy movement, individual states have been passing laws requiring women to be notified of their density status, creating a patchwork of regulation across the U.S.
The FDA in 2018 agreed to set a national standard by rolling breast density reporting into an update of the MQSA. But the long wait has frustrated many in the breast density advocacy movement.
There are several major components to the new rule, which:
- Requires breast imaging facilities to provide patients with a summary of the mammography report written in lay terms that identifies whether patients have dense or non-dense breast tissue.
- Instructs facilities to include a section in the mammography report explaining the significance of breast density.
- Establishes four categories for reporting breast tissue density in the mammography report.
- Sets the specific language to be used for reporting density.
The new rules provide much-needed national consistency in breast density reporting, and will replace the patchwork of state regulation that has developed over the years. Developers of breast density software may also benefit from the new federal rules, as they simplify the number of regulations that need to be tracked.
The Takeaway
Better late than never. While the FDA should have signed off on this years ago, now that the rules are issued the breast imaging community can move ahead with integrating them into clinical practice. The new rules should also help density reporting software developers by setting a national standard rather than a patchwork of state regulation.
