President signs new law reauthorizing Medical Device User Fee Act and enacting broad-ranging FDA Safety and Innovation Act
15 August 2012Medical Device Alert
On July 9, 2012, President Obama signed into law the FDA Safety and Innovation Act (FDASIA). The new law implements nearly three dozen provisions relevant to the medical device industry, in addition to reauthorizing the Medical Device User Fee Act (MDUFA III). Reauthorization of MDUFA links higher device user fees with concrete and escalating goals for improving premarket review times, and implements significant changes to how FDA’s performance will be tracked and measured.