FDA Issues a Proposed Rule Amending Mammography Regulations

Today, the U.S. Food and Drug Administration issued a proposed rule to amend its regulations governing mammography. The amendments, if finalized, would update the regulations implementing the Mammography Quality Standards Act of 1992 (MQSA). The FDA is taking this action to address changes in mammography technology and mammography processes since the regulations were published in 1997.

The proposed rule would update mammography reporting requirements to patients and health care providers to include, among other things, notification of breast density, enhanced mammography facility identification information, and additional assessment categories. These actions are intended to facilitate better communications between mammography facilities, health care providers and patients; facilitate the retrieval of mammography images; and help ensure that health care providers and patients are obtaining adequate information to make informed medical decisions.

Comments to this proposed rule should be submitted either electronically or in writing no later than 90 days after date of publication in the Federal Register.

Center for Devices and Radiological Health

Food and Drug Administration