With mobile medical apps to track fitness and monitor other vital signs, developers have many questions — and seemingly few answers — on how their products will be regulated.
The FDA has said it would exercise enforcement discretion for mobile medical applications (MMA) that may meet the definition of a “device” under the FD&C, but present only a low risk to patients.
However, for apps that don’t clearly fall within an existing classification, devicemakers may need to contact FDA for advice, said Michele Buenafe, partner for law firm Morgan, Lewis & Bockius, during a recent FDAnews webinar.
The FDA has tried to clear up which apps fall under its regulatory purview via final guidance issued in September 2013. The agency said it would only apply its regulatory hand to “a small subset of mobile apps that may present a risk to patients should they fail to function as intended,” Buenafe said.
The guidance is unique in that it lists various apps the FDA intends to regulate, as well as those it would not. “In other words, FDA is providing guidance by example rather than providing a specific rule to figure out what is or is not regulated,” she said.
Buenafe presented examples of apps that would be regulated, such as a camera to detect skin conditions and those used as surgical cameras. Meanwhile, apps that serve as videoconferencing portals intended for medical use only are subject to enforcement discretion.
Digital health includes not only MMAs but also “clinical decision support software, wearable devices and sensors, telemedicine devices, remote monitoring systems, medical device data systems, medical image storage and communication systems and other health IT products,” she said.
Despite the examples the FDA laid out, the area of clinical decision support software remains in limbo due to the absence of guidance. CDRH head Jeffrey Shuren has said that will be addressed in guidance, and FDA officials have said the agency is working on the document.
In addition, the agency has yet to finalize draft guidance differentiating between medical device and health and fitness technologies, further muddying the waters.