Last month, Mobile MIM became the first diagnostic radiology application to be approved by the Food and Drug Administration. The news traveled fast through the mobile health community because, so far, the FDA hasn't provided manufacturers with official guidance regarding such products.
But change could be on the horizon. Stewart Eisenhart, who covers medical device regulatory affairs for Emergo Group, writes in MassDevice today:
According to information provided by FDA officers at the town hall, software validation will be required for mobile medical applications. Whether such devices would have to go through 510(k) or pre-market approval processes, or be ruled 510(k)-exempt - has not yet been determined, they said.
As mobile application and medical device technologies will only converge at a steadier rate going forward, the FDA's pending guidance on this industry-changing trend should prove highly influential in both how manufacturers devise mobile capabilities and how other regulators develop their own approaches to such devices.