FDA to Require Breast Density Notification Amongst Other Updates to Mammography Regulations
FDA Law Blog
MARCH 15, 2023
By Véronique Li, Senior Medical Device Regulation Expert — Earlier this month, FDA published a final rule to update the mammography regulations, issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act). It authorized FDA oversight over mammography facilities.
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