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.

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