FDA to Require Breast Density Notification Amongst Other Updates to Mammography Regulations
FDA Law Blog
MARCH 15, 2023
See Government Accountability Office, “ GAO-06-724 Mammography: Current Nationwide Capacity Is Adequate, but Access Problems May Exist in Certain Locations ” (July 2006). A reader may miss a cancerous lesion if the image quality is poor, resulting in a false negative diagnosis, which could delay treatment and result in an avoidable death.
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