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 (in U.S. Dollars). All establishments are required to pay the establishment registration fee.
2105FY15 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 |