FDAnews Device Daily Bulletin

Lack of FDA Guidance Is Barrier to Promising mHealth App Market

Aug. 23, 2013
By the end of 2017, revenues from mHealth products will rise by 61 percent to $26 billion, according to a new analysis by Research2Guidance. But lack of final FDA guidance on mHealth apps is keeping devicemakers from realizing the full potential of this segment, the report says. App publishers surveyed for the report listed “missing regulations” as the main market barrier.
Devices & Diagnostics Letter