medical software regulation

By MHN Staff 06:52 am February 27, 2015
By Bradley Merrill Thompson Over the last couple years, FDA has clarified the scope of its regulation over mobile health. In the agency’s September 2013 guidance, FDA spelled out its oversight for some of the most common mobile medical apps. Then, last month, in two separate draft guidances FDA explained the limits on its oversight of apps used for general wellness like fitness trackers, as well...