The FDA’s New Breast-Density Notification Requirement: What You Should Know

Breast density is a common issue that many women face, but often go uninformed about. It can impact the accuracy of mammograms and increase the risk of breast cancer. To help address this issue, the U.S. Food and Drug Administration (FDA) announced in March 2023 that it would require mammography providers to notify women about the density of their breasts. Recently, the FDA shared key information about this forthcoming requirement, including the compliance deadline and other new requirements established under last year’s final rule.

First of all, why is breast density important, and why does it impact the accuracy of mammograms? Breast density refers to the ratio of fibrous, glandular tissue to fatty tissue in the breast. Dense breasts have more fibrous and glandular tissue and less fatty tissue, making it harder for mammograms to detect cancer. In addition, women with dense breasts have a higher risk of developing breast cancer. However, many women are not aware of their breast density or how it affects their mammograms.

To address this issue, the FDA’s new requirement mandates that mammography providers notify women about their breast density and provide information about the potential implications of breast density on the accuracy of mammograms. Specifically, mammography reports must include an overall assessment of breast density classified in one of four categories, along with a patient lay summary. Women must also be informed that they have dense breast tissue and that it can make it harder for mammograms to detect cancer.

It’s important to note that the FDA has set a compliance deadline for this requirement. Facilities subject to the Mammography Quality Standards Act (MQSA) will have until Sept. 10, 2024, to come into compliance. This gives providers and facilities time to prepare for the new requirement and makes sure that they are following all the regulations applicable to them under the MQSA.

In addition to the breast-density notification requirement, the FDA has established other new requirements under last year’s final rule. Mammography providers will be subject to an annual “medical outcomes audit” that covers positive predictive value, cancer detection rate, and recall rate for each interval. MQSA inspectors will also look for new items, including communication of exam results.

It’s important to note that facilities that don’t comply with these regulations may face enforcement action from the FDA, whether observed during an annual inspection or determined by other means. As a patient, you have the right to ask your healthcare provider about your breast density and whether you may need additional screening tests beyond mammograms.

Breast density is an important issue that many women face, but often go uninformed about. The FDA’s new breast-density notification requirement aims to provide women with important information about their breast density and how it can impact the accuracy of mammograms. As a patient, it’s important to be aware of this requirement and to talk to your healthcare provider about your breast density and any additional screening tests you may need. By working together, we can improve breast cancer detection and save lives.