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 |