The FDA is raising the user fees medical device makers pay for the safety watchdog to review its products by more than 4%.
The user fees for fiscal 2016, which begins Oct. 1, 2015 are going up 4.2% over the fiscal 2015 fees for both small businesses making less that $100 million annually and for their larger brethren, the FDA’s Center for Devices & Radiological Health said today.
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. The agency cut the fees by -2.9% for fiscal 2015, having raised them by 4.2% for FY2014.
The fiscal 2016 rates would see PMA applications cost $ for large companies (up from $250,895), with small-business PMAs running $ (up from $62,724). Applications for 510(k) clearances would cost $ (up from $5,018) for large firms and $ (up from $2,509) for small businesses. The new fees are slated to generate an estimated $137.7 million for the FDA, according to the Federal Register.
Here’s how this year’s changes break down: