Some mHealth tech to be exempted from FDA clearance process

The FDA has issued a guidance document detailing the agency’s plans not to require premarket submissions for several Class I and II medical devices and mobile health applications. Among the innovations that will be exempted from FDA oversight are those that don’t present risks to users, such as hearing aids, fitness and wellness applications as well as tools that could turn cellphones into stethoscopes or thermometers. A copy of the guidance can be found here.

Posted in Apps, Technology