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 |
View full FDA notice, published to the Federal Register on Monday, August 3, here.
We can help you get your medical device through FDA, taking the least costly route with the greatest likelihood of approval. We use extensive scientific knowledge in concert with regulatory expertise to do this, allowing us to focus on getting you the desired approval from the Agency. For more information on how we can work with you to achieve a positive outcome at FDA, contact us today.