Tag Archives: Artificial Intelligence (AI)

FDA Outlines Proposed Framework for Regulating Artificial Intelligence Software

In a recent post on the Covington Digital Health blog, we analyze FDA’s recently-released proposed regulatory approach for medical devices that use artificial intelligence (AI) and machine learning (ML), which we refer to here as the “AI Framework.” The AI Framework does not establish new requirements or an official policy, but rather was released by FDA … Continue Reading

Gottlieb Sees “Vast Potential” Ahead for Digital Health

Advancing digital health technologies is one of FDA’s strategic priorities for 2018.  FDA’s Center for Devices and Radiological Health (CDRH) has traditionally taken a leading role in establishing FDA’s regulatory policies toward digital health technologies, and recent FDA announcements on digital health indicate that CDRH will continue efforts to develop new agency approaches toward digital … Continue Reading
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