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 FDA's promise of faster approval times. These fees are amended and announced for each fiscal year (October 1 - September 30 of each year) and in order to avoid a delay in the review of your application, must be paid at or before submittal. In addition, there are ways to qualify for a reduced fee, such as a reduced small business fee, The Weinberg Group can help address this.
FDA recently released their medical device user fee rates for fiscal year 2016, which are as follows:
Application Type |
Standard Fee for FY2016 |
Small Business Fee for FY2016 |
Premarket Application (PMA, BLA, PDP) | $261,388 |
$65,347 |
Premarket Report (for a reprocessed single-use device) | $261,388 |
$65,347 |
Panel-Track PMA Supplement | $196,041 |
$49,010 |
BLA Efficacy Supplement | $261,388 |
$65,347 |
180-Day Notice | $39,208 |
$9,802 |
Real-Time PMA Supplement | $18,297 |
$4,574 |
Premarket Notification (510(k)) | $5,228 |
$2,614 |
30-Day Notice | $4,182 |
$2,091 |
513(g) Request for Classification Information | $3,529 |
$1,765 |
Annual Fee for Periodic Reporting on a Class III Device | $9,149 |
$2,287 |
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...
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...
August 7, 2015
In order to expedite the review process of biosimilar biological products, FDA is authorized to assess and collect fees from sponsors. The fees are collected for various activities related to...