FDA Medical Device User Fee Rates: Fiscal Year 2019

August 14, 2018

On Monday, July 30th, FDA released the medical device user fee rates for fiscal year 2019. The total FY 2019 revenue amount, prior to adjustments, is $190,654,875. Medical device user fee rates are updated each fiscal year and must be paid at or before the time of submittal to avoid delays in the review process.

Medical device user fee rates are split up into two categories based on the size of the business submitting the application. The updated rates for FY 2019 are as follows:

Application Type Standard Fee for FY 2019 Small Business Fee for FY 2019
Premarket Application (PMA, BLA, PDP) $322,147 $80,537
Premarket Report $322,147 $80,537
Efficacy Supplement $322,147 $80,537
Panel-track Supplement $241,610 $60,403
De Novo Classification Request $96,644 $24,161
180-Day Supplement $48,322 $12,081
Real-time Supplement $22,550 $5,638
510(k) Premarket Notification Submission $10,953 $2,738
30-Day Notice $5,154 $2,577
513(g) Request for Classification Information $4,349 $2,175
Annual Fee for Periodic Reporting (Class III Device) $11,275 $2,819
Annual Establishment Registration Fee $4,884 $4,884

 

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