FDA set the medical device fee structure for FY17 (Oct. 1, 2016 to Sep. 30, 2016)
Activity | Standard Fee | Small Business Fee |
---|---|---|
Establishment Registration | $3,382 | $3,382 |
510(k) | $4,690 | $2,345 |
513(g) | $3,166 | $1,583 |
PMA, PDP, PMR, BLA | $234,495 | $58,624 |
panel-track supplement | $175,871 | $43,968 |
180-day supplement | $35,174 | $8,794 |
real-time supplement | $16,415 | $4,104 |
BLA efficacy supplement | $234,240 | $58,560 |
annual report | $8,207 | $2,052 |
30-day notice | $3,752 | $1,876 |