On October 1, 2017, FDA FYI 2018 MDUFA User Fees (Medical Device application filing fees) will see a sharp price increase.
Especially striking is the introduction of fees for De Novo submissions, which will now bring a high price tag.
Here's a summary of just how much more these fees will cost.
Standard Fee Increases
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510(k): $4,690 (FY17) to $10,566 (FY18) ⟶ $5,876 increase
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513(g): $3,166 (FY17) to $4,195 (FY18) ⟶ $1,029 increase
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De Novo: $0 (FY17) to $93,220 (FY18) ⟶ $93,220 increase
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PMA, PDP, PMR, BLA: $234,495 (FY17) to $310,764 (FY18) ⟶ $76,269 increase
See FDA's official MDUFA announcement and compare to last year's statement for details and changes to related Small Business Fees.
For any company in the process of preparing and/or submitting a Medical Device submission to FDA, contact us today to ensure you'll be able to make your submission before the new user fees take effect.