Back to all Thought Leadership

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

 

Are you in the process of developing a medical device application for submission to the FDA? We can help with any and all of your medical device needs.  To learn more about our medical device consulting capabilities and how we can help you, contact us today.
Agency Alerts Regulatory Sciences



Related Articles

Agency Alerts General Regulatory

August 3, 2016

FDA Medical Device User Fee Rates: Fiscal Year 2017

On Friday, July 29th, FDA announced its 2017 Medical Device User Fee rates and payment procedures, which will take effect on October 1, 2016 and remain in place until September 30, 2017.  These fees...

Read the Full Article
Agency Alerts

August 4, 2015

FDA Medical Device User Fee Rates: Fiscal Year 2016

Starting in 2002, the FDA began implementing "user fees" in which manufacturers of medical devices wishing to obtain approval from the Agency would pay the pre-specified amount in return for the...

Read the Full Article
Agency Alerts

August 8, 2018

FDA Biosimilar User Fee Rates: Fiscal Year 2019

On Tuesday, July 31st, FDA released a notice with updated biosimilar user fee rates for fiscal year 2019. The base revenue for FY 2019 is $40,214,000, not adjusted for inflation or operating...

Read the Full Article