One of the many roadblocks developers face when innovating in the mHealth space is the approval process for clearing new applications with the FDA.

A new rule that was recently introduced, however, aims to streamline that process for certain applications.  The new “Medical Device Data Systems” (MDDS) rule now exempts a portion of smartphone apps and wireless peripherals from the FDA’s pre-review requirements.  Put simply, the new MDDS rule applies to medical devices or software that only collects, stores or transfers patient data.  An example being an app that collects weight or other vital signs from plug-in peripherals and forwards that data to physicians.

Before, devices and software that fell into this category were classified as “Class III,” meaning they were subject to the FDA’s lengthy approval process before being sold.  The new rule now categorizes these units as “Class I,” with no such pre-approval requirements.  This greatly reduces time-to-market for vendors creating such apps.  While the new rule does simplify the process for a portion of mHealth apps, it still excludes more advanced applications that go beyond collecting, storing or transferring patient data, which are becoming more commonplace as the market evolves.

Still, as a silver lining, creating the new rule forced the FDA to dig deeper into the mobile health device and software market, which gave them a better understanding of the problems vendors face while innovating in the space.  This is hopefully a step in the direction of the FDA streamlining the approval process across the board for mHealth applications, which will be a huge step forward in advancing the industry as a whole.