FDA Medical Device User Fee Rates: Fiscal Year 2017

August 3, 2016

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 have decreased significantly compared to the Agency's 2016 rates, and are lower than they have been in the past few years.  Furthermore, FDA also notes that there are ways to qualify for reduced fees, such as a reduced small business fee.  However, in order to pay this reduced fee, you must qualify as a small business before making your submission to FDA.  Contact us if you think you may qualify, The Weinberg Group can help you address this.

In its notice, FDA states that “the FD&C Act specifies the base fee for a premarket application for each year from FY 2013 through FY 2017; the base fee for a premarket application received by FDA during FY 2017 is $268,443. From this starting point, this document establishes FY 2017 fee rates for other types of submissions, and for periodic reporting, by applying criteria specified in the FD&C Act.”

The following are FDA’s medical device user fee rates for fiscal year 2017:

Application Type FY 2017 Standard Fee FY 2017 Small Business Fee
Premarket Application (PMA, BLA, PDP) $234,495 $58,624
Premarket Report $234,495 $58,624
Efficacy Supplement (to an approved 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
510(k) Premarket Notification Supplement $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 on a Class III Device $8,207 $2,052
Annual Fee for Establishment Registration $3,382 $3,382


We can help you get your medical device through the FDA, taking the least costly route with the greatest likelihood of approval.  For more information on how we can work with you to achieve a positive outcome at FDA, contact us today.


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...

August 14, 2018

FDA Medical Device User Fee Rates: Fiscal Year 2019

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...

September 29, 2023

Navigating FDA User Fee Updates for Fiscal Year 2023

As the U.S. Government begins its fiscal year on October 1, it signifies the annual revisions in FDA User Fees, which have an impact on applications and facilities associated with Prescription Drugs...