Weekly Vitals: MDUFA Settled 'In Principle,' Medtech Bills Introduced, and More

Posted by Shana Leonard on February 3, 2012
The heated debate concerning the reauthorization of the Medical Device User Fees that has had the medical device industry on the edge of its seat for more than a year may finally be winding down. FDA announced this week that it had reached an agreement 'in principle' with industry that would allow FDA to collect higher user fees of $595 million over five years in exchange for new goals for time frames for PMA and 510(k) submissions. On the heels of this news, House Democrats introduced a bill that would close a loophole in the 510(k) clearance process associated with safety recalls. Adding to the flurry of activity, a bipartisan bill was also introduced this week that aims to streamline the regulatory pathway for medical devices to promote innovation. Read about these and other medtech highlights from the past week in our roundup below.