Yesterday, the Senate approved the Food and Drug Administration Safety and Innovation Act (FDASIA) which provides reauthorization for major components of the Prescription Drug User Fee Act (PDUFA) set to expire at the end of September. An important development not being widely covered, is that the reconciled bill removes language that had been added by the Senate prohibiting the Food and Drug Administration (FDA) from final rulemaking on mobile medical apps and related technologies. As a result, the FDA is now free to issue final rules providing guidance for this rapidly growing industry. FDA draft guidance on mobile medical apps was issued in July of 2011. The legislative move is seen as a positive development for the emerging digital health sector.

Michael Shuster