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

FDA fees 2 FDA 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%