Friday, August 1, 2014

FDA Announces Medical Device User fee for FY 2015

                 
The annual establishment registration fee must be paid between October 1, 2014 and December 31, 2014. For FY15, the registration fee for each establishment is $3,646 

                                     FY15 User Fees (in U.S. Dollars)

application type
standard fee
small business fee
510(k)
$5,018
$2,509
513(g)
$3,387
$1,694
PMA, PDP, PMR, BLA
$250,895
$62,724
panel-track supplement
$188,171
$47,043
180-day supplement
$37,634
$9,409
real-time supplement
$17,563
$4,391
BLA efficacy supplement
$250,895
$62,724
annual report
$8,781
$2,195
30-day notice
$4,014
$2,007