FDA Voice Blog: Fostering Medical Innovation – A Plan for Digital Health Devices

"FDA will soon be putting forward a broad initiative that is focused on fostering new innovation across our medical product centers," according to Scott Gottlieb, M.D. Commissioner of the U.S. Food and Drug Administration. "I will have more to say on many elements of this initiative soon. However, today I want to focus on one critical aspect of this innovation initiative: A new Digital Health Innovation Plan that is focused on fostering innovation at the intersection of medicine and digital health technology. This plan will include a novel, post-market approach to how we intend to regulate these digital medical devices."
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