The FDA will raise med device user fees more than 4% |

The FDA will raise med device user fees more than 4%

FDA fees 2FDA raises medical device user fees more than 4% (MassDevice)

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 $188,171 4.2% $49,010 $47,043 4.2%
180-day supplement $39,208 $37,634 4.2% $9,802 $9,409 4.2%
Real-time supplement $18,297 $17,563 4.2% $4,574 $4,391 4.2%
Annual fee for periodic Class III reporting $9,149 $8,781 4.2% $2,287 $2,195 4.2%
30-day notice $4,182 $4,014 4.2% $2,091 $2,007 4.2%
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