Under the new Generic Drug User Fee Amendments of 2017 (GDUFA II) and Medical Device User Fee Amendments of 2017 (MDUFA IV), the US Food and Drug Administration (FDA) will collect significantly higher user fees for some applications than in recent years though how the fees are calculated has been restructured under the two new agreements.
For instance, device companies submitting 510(k) applications, which are for devices equivalent to ones already marketed, fees will more than double, from $4,690 in 2017 to $10,542 in 2018.
Similarly, applications to market generic drugs, known as abbreviated new drug applications (ANDAs), will see fee increases of more than $100,000, from $70,480 in 2017 to $171,823 in 2018.
The fees were set based on negotiations between industry and FDA as part of a new five-year reauthorization of the FDA user fee programs signed into law earlier this month.
FDA issued notices for both the MDUFA IV and GDUFA II fee rates for FY 2018 on Monday. The rates apply from 1 October 2017 through 30 September 2018.
“To avoid delay in the review of your application, you should pay the application fee before or at the time you submit your application to FDA,” the agency said.
The fee rate for each type of device application submission to FDA is set at a specified percentage of the standard fee for medical devices.
For instance, the base fee for a premarket application (including a premarket approval application (PMA), a product development protocol (PDP) or a biologics license application (BLA)) received by FDA during FY 2018 is $310,764, which is almost $80,000 more than the fee for such applications in FY 2017, though that figure has fluctuated in recent years.
And the annual fee for establishment registration is $4,624 in 2018, which is about $1,000 more than the fee from 2017 and other recent prior years. FDA also notes that the establishment registration fee is not eligible for a reduced small business fee.
There is also a new fee, established under MDUFA IV that did not exist in prior years for de novo classification requests, which will run companies $93,017, while small businesses will have to pay $23,254.
FDA on Monday also issued a 39-page guidance for device companies in determining how to qualify and be certified as a small business in FY 2018. "This is defined as having gross receipts or sales of no more than $100 million for the most recent tax year," the guidance says.
But in contrast to the spike in ANDA fees and other device fees for FY 2018, other generic drug fees, such as those for domestic and foreign active pharmaceutical ingredient and finished dosage form facilities, saw only modest increases or slight decreases (domestic FDF facilities will pay $211,087 in FY 2018, but paid $258,646 in 2017).
In addition, new fees were established under GDUFA II for domestic and foreign contract manufacturing organizations, which in FY 2018 must pay $70,362 and $85,362, respectively.
Medical Device User Fee Rates for Fiscal Year 2018
Generic Drug User Fee Rates for Fiscal Year 2018