So far the FDA has reviewed a total of approximately one hundred mobile health apps since these apps started becoming available – and yet hundreds of new health apps appear on the market every month. As reported in our previous blog entries (see April 2014, and September and October 2013), the FDA is regulating health information technology with as light a touch as possible, in line with the FDASIA Health IT Report draft released in April 2014. This means that for now the FDA regulates only applications that fall under its “medical device software” definition – that is software intended for medical devices, or software that transforms a smartphone into a medical device. All other health-related software is considered lower risk or no risk and is currently not subject to pre-market regulation. Industry observers are, however, concerned that the sheer volume of new health apps coming to market is so great that the FDA may not be in a position to monitor much less regulate the new products adequately. Many apps, currently exempt from pre-market regulation, actually fall into a category between the low risk and higher risk definitions and may not be receiving sufficient oversight, observers worry. Lawmakers have called for Congress to establish a department within the FDA to focus specifically on mobile applications.
See PBS Newshour article at “FDA regulation can’t keep pace with new mobile health apps”