“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 as apps that may beaccessories to a medical device. And already in February, FDA published a final guidance deregulating medical device data systems, a category that includes numerous mobile apps. The agency has been busy.
“But one area FDA has yet to clarify is apps that guide the appropriate use of drugs. Many of those apps potentially fit the category of clinical decision support (CDS) software, an area that FDA has been planning guidance since 2011, but so far has not addressed.”