New rule directs mammography facilities to tell patients about breast density

Regulatory NewsRegulatory News | 10 March 2023 |  By 

The US Food and Drug Administration (FDA) has issued a final rule intended to ensure patients are better informed about their breast tissue density when undergoing mammography. The rule updates regulations first issued in the 1990s under the Mammography Quality Standards Act to oversee mammography facilities and improve breast cancer testing.
“Today’s action represents the agency’s broader commitment to support innovation to prevent, detect and treat cancer,” said Hilary Marston, FDA’s chief medical officer in a press release on 9 March. “Since 1992, the FDA has worked to ensure patients have access to quality mammography.”
“The impact of the Mammography Quality Standards Act on public health has been significant, including a steep decrease in the number of facilities that do not meet quality standards,” she added. “This means that more women have access to consistent, quality mammography.”
Under the new rule, mammography facilities need to inform patients about the density of their breasts. Research shows about half of women in the US over the age of 40 tend to have high-density breast tissue, which not only makes it harder for mammography tests to detect breast cancer but also puts them at higher risk for contracting the disease. The final rule addresses that issue by providing specific language about how breast tissue density can affect mammography tests and recommends patients with high breast tissue density talk to their healthcare provider about their breast density and risks for breast cancer.
While FDA said that nearly all certified mammography facilities meet quality standards, the final rule gives it the ability to talk to mammographers directly, and if needed the ability to talk to patients and their healthcare providers about mammography facilities that don’t meet quality standards and are not adequately communicating with patients about their breast tissue density. This ability will help ensure the agency can share information that could significantly affect patient care decision, such as the need for additional evaluations or repeat mammograms, FDA said.
“The amendments also help bring the MQSA into the 21st century, including modernizing the regulations by incorporating current science and mammography best practices to improve breast cancer detection and helping empower patients with more information when they are considering important decisions regarding their breast health care,” FDA added.
Mammography facilities have 18 months to comply with the final rule.


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