FDA Proposes Updates to Mammography Standards for First Time in 20 Years

In an effort to enable healthcare providers and patients to make more informed medical decisions, the FDA has proposed amendments to key policies to modernize breast cancer screening and improve mammography services.¹

For the first time in 20 years, the agency’s proposal would modify regulations that were issued under the Mammography Quality Standards Act (MQSA) of 1992, which was passed by Congress and enforced by the FDA to help ensure the delivery of high-quality mammography services.

“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, like the increased use of 3-D digital screening tools and the need for more uniform breast density reporting,” said FDA commissioner Scott Gottlieb, MD. “Today’s proposed rule would help to ensure patients continue to benefit from advances in new tools and robust oversight of this field.”

The proposed changes were drafted to accomplish the following: improve patient understanding of the relationship between breast density and breast cancer risk, to provide physicians with more detailed information to improve mammogram assessments, and to provide the FDA with the ability to better enforce the MQSA regulations and actively address violations.

Prior research has shown that breast density surpasses all other known risk factors for developing breast cancer, including having a personal history of benign lesions or a family history of the disease.²Breast density can occasionally reduce the sensitivity of images, making mammograms difficult to interpret. To improve understanding of these challenges, the FDA has suggested that the MQSA include specific language to explain how breast density can impact the accuracy of these tests. The agency also proposed to include a recommendation that patients with high breast density have a conversation with their provider to learn more about how breast density correlates with cancer risk.

“Given that more than half of women over the age of 40 in the United States 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,” said FDA principal deputy commissioner Amy Abernethy, MD, PhD.

To improve the assessment of mammograms, the FDA has proposed to codify 3 additional categories. Notably, “known biopsy proven malignancy” was included among the suggested categories as a way to help physicians identify those who are undergoing mammographic evaluation for therapy for a cancer that has already been previously identified.

Beyond this, the proposed amendments also call for distribution of additional detailed information regarding mammogram facilities to both patients and providers, as a way to help the post-exam process run smoother.

Other notable policy changes that the agency suggested, but are not limited to:

• The FDA should be provided with the ability to directly contact patients and providers if a mammogram failed to meet quality standards and to inform them of the possibility that they may need to go for another test at a different certified facility;
• To modernize quality standards, facilities should only use digital accessory components that have received regulatory approval or clearance for mammography;
• Bolstered requirements for record-keeping are needed to improve access to and transfer of mammography records and to reduce loss of information;

“While the majority of certified mammography facilities are dedicated to providing high levels of patient care, today’s proposed regulations would enhance the FDA’s ability to communicate directly, if needed, with patients and their healthcare professionals in cases where facilities did not meet our quality standards and are not adequately communicating with patients about their facilities’ deficiencies,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health.

The FDA has shared the proposed amendments online for public comment for 90 days post-publication.

References:

1. FDA Advances Landmark Policy Changes to Modernize Mammography Services and Improve Their Quality. FDA. Published March 27, 2019. https://bit.ly/2HHXqx4. Accessed March 27, 2019.
2. Engmann NJ, Golmakani MK, Miglioretti DL, et al. Population-attributable risk proportion of clinical risk factors for breast cancer.JAMA Oncol. 2017;3(9):1228-1236. doi: 10.1001/jamaoncol.2016.6326.