This browser is not actively supported anymore. For the best passle experience, we strongly recommend you upgrade your browser.
Welcome to Reed Smith's viewpoints — timely commentary from our lawyers on topics relevant to your business and wider industry. Browse to see the latest news and subscribe to receive updates on topics that matter to you, directly to your mailbox.
| 1 minute read

Expect breast density notification rules soon from FDA

In a letter written last week to U.S. Congresswoman Rosa DeLauro (D-Connecticut), Chair of the House Appropriations Committee, the U.S. Food and Drug Administration (FDA) provided a timeline on the agency's expected rollout of final new breast density notification rules. In 2019, FDA proposed rules that would require screening mammography providers to notify women in reports written in lay language whether they have dense breasts and whether they may need additional screenings to find breast cancer.

The proposed rule would require the "lay summary" to screening patients to include a prescribed paragraph on the significance of breast density. The proposed regulations would also establish four categories for reporting breast tissue density in the mammography report that is provided to the patient’s referring healthcare provider. This is significant because dense breast tissue is known to be one of the factors that increases the chances that a woman will develop breast cancer, and thus is considered to be a risk factor for breast cancer.

Currently, laws are in place in 38 states and the District of Columbia to require some level of breast density notification to patients after having received a mammogram. But not every state with such laws requires mammographers to notify patients of their personal breast density status. If the FDA's rule is promulgated as proposed, every US mammography facility will be required to provide their patients information about their breast density, if applicable.

FDA advised Rep. DeLauro that they are optimistic that the final rule will publish before the end of the 2022 calendar year or by early 2023.

...FDA proposed to modernize and improve the regulations and information, including breast density information, provided by mammography facilities to patients and their healthcare providers.


health care & life sciences, diagnostic radiology, mammography