2016 FDA Medical Device User Fee Rates

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 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

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.

View full FDA notice, published to the Federal Register on Monday, August 3, here.