FDA issues proposed changes in mammography rules

Newly proposed Food and Drug Administration amendments to regulations on mammography aim to give more information to patients and improve quality standards.

The changes—the first involving mammography facilities in more than 20 years—are a result of the agency’s push to modernize mammography services, intending to modernize breast cancer screening and to empower patients by giving them more information.

In addition to sharing more information on imaging studies for patients—most significantly, breast density reporting—the agency’s proposed rule, issued on Wednesday, would seek to extend oversight of technological advances in mammography, such as digital breast tomosynthesis and other 3-D screening tools.

“As part of our overall commitment to protecting the health of women, we’re proposing new policies to modernize our oversight of mammography services, by capitalizing on a number of important advances in mammography,“ says FDA Commissioner Scott Gottlieb, MD. “We’re committed to making sure patients have access to high-quality mammography. Today’s proposed rule would help to ensure patients continue to benefit from advances in new tools and robust oversight of this field.”

The FDA’s proposal would amend regulations issued under the Mammography Quality Standards Act of 1992 (MQSA), which Congress passed to ensure quality mammography for early breast cancer detection. The MQSA authorizes FDA oversight over mammography facilities, including their accreditation, certification, annual inspections and enforcement of standards to help ensure mammography facilities provide quality care.

The proposed amendments include a requirement to add breast density information to the mammography lay summary letter provided to patients and to the medical report provided to their referring healthcare professionals. Mammograms of dense breasts—breasts with a higher proportion of fibroglandular tissue compared to fatty tissue—can be difficult to interpret because the dense tissue can obscure signs of breast cancer and lower the sensitivity of the image. Dense breasts have also been identified as a risk factor for developing breast cancer.



“Given that more than half of women over the age of 40 in the U.S. have dense breasts, helping to ensure patient access to information about the impact that breast density and other factors can have on the risk for developing breast cancer is an important part of a comprehensive breast health strategy,” says FDA Principal Deputy Commissioner Amy Abernethy, MD.

The proposed amendments also seek to enhance information provided to healthcare professionals by proposing to codify three additional categories for the assessments of mammograms, including adding a category entitled “known biopsy proven malignancy,” which would help identify those cases where cancer being mammographically evaluated for therapy are already known and identified. In addition, under the proposed regulations, both healthcare professionals and patients would receive more detailed identifying information about the mammography facility to aid in post-exam communications.

Among other changes, the rule would strengthen record-keeping requirements to minimize information loss and improve access to and transfer of patient mammography records.

The proposed rule is available here for public comment for 90 days from publication.