FY17 Medical Device Fees

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