Medical Device Submission & Filing Fees Are About to Rise Significantly

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

• 510(k): $4,690 (FY17) to $10,566 (FY18) ⟶ $5,876 increase
• 513(g): $3,166 (FY17) to $4,195 (FY18) ⟶ $1,029 increase
• De Novo: $0 (FY17) to $93,220 (FY18) ⟶ $93,220 increase
• 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.

• FY 2017 MDUFA User Fees

• FY 2018 MDUFA User 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.