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
|
