Tag Archives: MQSA

FDA Announces New Proposed Rule to Enhance Mammography Services

On March 27, 2019, the FDA announced that it would be proposing new amendments to key regulations regarding mammography facilities that would require these entities “to tell women more about how dense breast tissue can affect their health and increase their cancer risk.”  The proposed changes to mammography facility regulations would be the first issued in more than 20 years.  The FDA believes the change will “expand the information mammography facilities must provide to patients and health care professionals, allowing for more informed medical decision-making.”  In addition, FDA is proposing to modernize quality standards by, for example, expressly authorizing FDA communications with patients and practitioners in the event of quality issues, requiring use of FDA-approved or -cleared digital accessories, and strengthening recordkeeping requirements.  These changes not only enhance regulatory requirements, but likely foreshadow increasing enforcement and communications from FDA with regard to mammography services.

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