On December 8, 2017 – nearly a year after President Obama signed into law the 21st Century Cures Act (“Cures Act”) – the Food and Drug Administration (“FDA”) released two new draft guidances that aim to implement section 3060 of the Cures Act, and provide clarity on the Agency’s regulatory approach to software as a medical device.
As explained in a statement by FDA Commissioner Scott Gottlieb, the new draft guidances “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.”
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