January 20, 2015
Bradley Merrill Thompson
At the end of last week the FDA posted two draft guidance documents related to digital health. One focused on clarifying the line (PDF) between a general wellness device or app and a regulated medical device. The other intended to help clarify when an "accessory" device (PDF) to a regulated medical device, like a companion smartphone app, for example, would also fall...
May 25, 2013
By Bradley Merrill Thompson
As MobiHealthNews reported earlier, this week FDA sent an enforcement letter to the developer of a urinalysis app. This might sound weird, but I believe that’s good news for the mobile health industry.
Full disclosure, I may have played a part in FDA’s decision to send that letter. Over the last several months, I’ve had four occasions to talk about the app publicly,...