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FDA Announces FY16 User Fee Rates

FDA announced FY16 fee rates and payment procedures for medical device user fees, which apply from 10/1/15 through 9/30/16. Under the user fee system, device companies pay FDA when they register their establishments and list devices with the agency, when they submit an application or a notification to market a new medical device in the U.S. and for certain other submissions. The collected fees are intended to support FDA’s endeavors to conduct efficient, timely and transparent reviews.
 
For FY16, the fee for establishment registration is $3,845, up from $3,646 for FY15. There is no fee reduction for small businesses, but they do qualify for lower user fees on certain application types. (Per FDA, if your business has gross receipts or sales of no more than $100MM for the most recent tax year, you may qualify. If your business has gross sales or receipts of no more than $30MM, you may also qualify for a waiver of the fee for your first premarket approval application, product development protocol, biologics license application or premarket report.)
 
The table below summarizes FY16 rates for all medical device fees, compared to rates for FY15. Fees for 510(k) submissions increased by $210 standard and $105 for a small business; PMA fees increased by $10,493 and $2,623, respectively.
 
Application Fee Type FY 2016 Standard Fee FY 2015 Standard Fee FY 2016 Small Business Fee FY 2015 Small Business Fee

Premarket application
(PMA, PDP or BLA)
 
$261,388 $250,895 $65,347 $62,724

Premarket report 
 
$261,388 $250,895 $65,347 $62,724

Efficacy supplement
(to an approved BLA)
 
$261,388 $250,895 $65,347 $62,724

Panel-track supplement
 
$196,041 $188,171 $49,010 $47,043

180-day supplement
 
$39,208 $37,634 $9,802 $9,409

Real-time supplement
 
$18,297 $17,563 $4,574 $4,391

510(k) premarket
notification submission

 
$5,228 $5,018 $2,614 $2,509

30-day notice
 
$4,182 $4,014 $2,091 $2,007

513(g) request for classification information
 
$3,529 $3,387 $1,765 $1,694

 

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