Medical Devices User Fees for Fiscal Year 2017 (August 2016)

The Food and Drug Administration (FDA) is introducing new rates for certain medical device submissions for the 2017 fiscal year under the Food, Drug, and Cosmetic (FD&C) Act. Fee updates for the 2017 fiscal year include fees for medical device premarket approval applications and notifications, fees associated with requests for information and supplement submissions, and annual registration and listing fees for establishments which manufacture or distribute medical devices. In some cases, applicants may receive fee waivers and small businesses may pay a reduced fee.

Fee Type Standard Fee Small Business Fee
Premarket Application (PMA) $234,495 $58,624
Premarket Report $234,495 $58,624
Efficacy Supplement $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
510(k) premarket notification submission $4,690 $2,345
30-Day Notice $3,752 $1,876
513(g) Request for Classification Information $3,166 $1,583
Annual Fee for Periodic Reporting (Class III) $8,207 $2,052
Annual Establishment Registration $3,382 $3,382