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.
