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 & Radiological Health said today 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 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, the new fees would generate an estimated $131.2 million for the FDA, according to the Federal Register.
Here’s a comparison of the new user fee schedule for fiscal 2014 with the user fee rates for this fiscal year:
Application type | Fee for FY2014 | Fee for FY2015 | Percentage increase | Small business fee FY2014 | Small business fee FY2015 | Percentage increase |
510(k) | $5,170 | $5,018 | -2.9% | $2,585 | $2,509 | -2.9% |
513(g) | $3,490 | $3,387 | -3.0% | $1,745 | $1,694 | -2.9% |
PMA, PDP, PMR, BLA | $258,520 | $250,895 | -2.9% | $64,630 | $62,724 | -2.9% |
panel-track supplement | $193,890 | $188,171 | -3.0% | $48,473 | $47,043 | -3.0% |
180-day supplement | $38,778 | $37,634 | -3.0% | $9,695 | $9,409 | -3.0% |
Real-time supplement | $18,096 | $17,563 | -3.0% | $4,524 | $4,391 | -2.9% |
Annual report | $9,048 | $8,781 | -3.0% | $2,262 | $2,195 | -3.0% |
30-day notice | $4,136 | $4,014 | -3.0% | $2,068 | $2,007 | -3.0% |