This browser is not actively supported anymore. For the best passle experience, we strongly recommend you upgrade your browser.
| less than a minute read

FDA and the Future of Digital Health

New guidance just out from FDA on its approach to the regulation of digital health.  For companies pursuing opportunities where healthcare, tech, and life sciences intersect, this remains an area to watch.

Today, we’re announcing three new guidances – two draft and one final – that address, in part, important provisions of the 21st Century Cures Act (“Cures Act”), that offer additional clarity about where the FDA sees its role in digital health, and importantly, where we don’t see a need for FDA involvement. We’ve taken the instructions Congress gave us under the Cures Act and are building on these provisions to make sure that we’re adopting the full spirit of the goals we were entrusted with by Congress.

Tags

life science, medical devices, technology, health it, digital health

Tweets on this subject

Latest Insights

post featured image