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# FDA Requires More Mammography Reporting
- URL: https://www.fdaweb.com/fda-requires-more-mammography-reporting/
- Published: 2023-03-09T12:00:00.000Z
- Updated: 2026-09-14T18:18:37.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5153939

FDA has updated its mammography regulations to require mammography facilities to notify patients about the density of their breasts. An agency [notice](https://www.fda.gov/news-events/press-announcements/fda-updates-mammography-regulations-require-reporting-breast-density-information-and-enhance?ref=fdaweb.com) says the update also strengthens the agency’s oversight and enforcement of facilities and enables FDA to help doctors better categorize and assess mammograms.

The notice says advising patients about breast density is important because dense breast tissue can make cancers more difficult to detect on a mammogram. Dense breasts also have been cited as a risk factor for developing breast cancer, it says. About half of the women over age 40 in the U.S. have dense breast tissue, FDA says.

“Today’s amendments, which are required to be implemented within 18 months, enhance FDA’s oversight of mammography facilities, including in the key areas of enforcement and patient communication,” the notice concludes. “While nearly all certified mammography facilities continue to meet quality standards, today’s updates, among other things, enhance FDA’s ability to communicate directly, if needed, with patients and their healthcare providers in cases where a facility did not meet quality standards and is not adequately communicating with patients about its deficiencies. This is intended to help ensure important information that could affect decisions about patient care, such as the potential need for further evaluation or a repeat mammogram, is communicated as completely as possible.”