FDA raises medical device user fees more than 4%

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: Application type Fee for FY16 Fee for FY15 Percentage increase Small business fee FY16 Small business fee FY15 Percentage increase 510(k) premarket notification submission $5,228 $5,018 4.2% $2,614 $2,509 4.2% 513(g) request for classification information $3,529 $3,387 4.2% $1,765 $1,694 4.2% PMA, PDP, PMR, BLA $261,388 $250,895 4.2% $65,347 $62,724 4.2% Panel-track supplement $196,041 $188,17...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news