FDA updates mammography regulations to report on breast density, enhance oversight

The FDA updated mammography regulations to require facilities to inform patients about their breast density, improve oversight and enforcement of facilities and aid physicians to better categorize and assess mammograms.

“Today’s action represents the agency’s broader commitment to support innovation to prevent, detect and treat cancer,” Hilary Marston, MD, MPH, chief medical officer of the FDA, said in a press release. “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. This means that more women have access to consistent, quality mammography.”

The Mammography Quality Standards Act allows the FDA oversight over mammography facilities including accreditation, certification, annual inspections and enforcement of standards to aid in ensuring these facilities provide quality care.

In updates to these mammography regulations, the FDA will now require facilities to provide information regarding breast density to their patients, as dense breast tissue can be a risk factor for breast cancer development and can cause more difficulty in detecting cancers on mammograms. These updates provide specific language to explain how breast density can impact mammography accuracy and recommend that patients with dense breasts speak with their health care provider.

Another key update to these regulations will enhance the FDA’s oversight of mammography facilities and enhance the FDA’s ability to communicate directly with patients and their health care providers if a facility does not meet quality standards. These changes will help ensure important information that could impact patient care is well communicated with patients and health care providers.

These updates incorporate current science and mammography best practices and will be implemented within 18 months.

“We remain committed to advancing efforts to improve the health of women and strengthen the fight against breast cancer,” Marston said.