The regulatory status of medical apps, i.e mobile medical software, has been in limbo for some time now while observers have been watching the FDA for clues as to what role it will play. Clearly, some apps do play a role in guiding physicians in making diagnoses or making treatment decisions. Others simply provide information that would otherwise be available in textbooks or online.
What the FDA will consider a medical device or not has been an important topic, with many clues that it will consider its provenance broadly, as we have reported previously. As of now, only a few medical apps have been granted FDA approval, including AirStrip and MobileMIM.
According to the medical device consulting firm Emergo, the FDA said conclusively that they will be starting regulatory review of medical apps starting in 2011 at the recent FDA townhall meeting on March 10:
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.
The regulatory guidelines on mobile medical applications will be offered “later this year”. The statement was attributed to Jeffery Shuren, MD the director of the FDA’s Center for Devices and Radiological Health (CDRH) who led the Town Hall meeting, one a series of meetings held throughout the country to “to engage in a dialogue about issues that are of importance to the public.”
Obviously, this will lead many medical app developers to assess how their products will be be affected and whether their software is classified as a medical device. iMedicalApps will continue to observe this important issue closely.