A Breast Density Reporting amendment to the Mammography Quality Standards Act (MQSA) is scheduled to be issued as a Notice of Proposed Rulemaking in December 2013.
According to the abstract: “FDA is proposing to amend its regulations governing mammography. The amendments would update the regulations issued under the Mammography Quality Standards Act of 1992 (MQSA). The FDA is taking this action to address changes in mammography technology and mammography processes, such as breast density reporting, that have occurred since the regulations were published in 1997.”
The FDA’s consideration of a regulatory amendment to address breast density reporting could mean standardized nationwide notification in the “lay” letter women receive after their mammograms. Currently twelve states have enacted Breast Density Inform laws—about 40% of American women live in states with mandatory notification. The 12 individually authored laws yield inconsistent state-to-state density notification. Breast Density Inform grassroots advocates have sought a single standard through federal regulation or legislation.
