The FDA is cutting the user fees paid by medical device companies for the watchdog agency’s review by some 3% across the board for fiscal 2015. The FDA’s Center for Devices and Radiological Health (CDRH) said in July that it proposes to cut the fees for both small businesses making less that $100 million annually and for their larger brethren.
The cuts are slated to cover applications for 510(k) clearance, the more stringent pre-market approval process and a raft of other applications to the FDA. Last year in 2013, the FDA raised the user fee rates by 4.2%. The fiscal 2015 rates would see PMA applications cost $250,895 for large companies (down from $258,520), with small-business PMAs running $62,724 (down from $64,630). Applications for 510(k) clearances would cost $5,018 (down from $5,170) for large firms and $2,509 (down from $2,585) for small businesses. Set to go into effect October 1, 2015, the new fees would generate an estimated $131.2 million for the FDA, according to the Federal Register.
REFERENCE: Mass Device; 30 JUL 2014; Brad Perrillo