---
title: Medical Device Submission & Filing Fees Are About to Rise Significantly
description: Learn how much medical device submission fees (MDUFA) will increase in the fiscal year 2018 for 510(k) fees, 513(g) fees, De Novo fees, PMA fees, and more.
---

[Blog | The FDA Group ](https://www.thefdagroup.com/blog)

# [Medical Device Submission & Filing Fees Are About to Rise Significantly](https://www.thefdagroup.com/blog/medical-device-submission-filing-fees-are-about-to-rise-significantly)

 Written by [The FDA Group](https://www.thefdagroup.com/blog/author/the-fda-group) | September 11, 2017

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](https://www.fda.gov/forindustry/userfees/medicaldeviceuserfee/ucm452519.htm)

• [FY 2018 MDUFA User Fees](https://www.registrarcorp.com/fda-publishes-fy-2018-user-fees-for-medical-devices-and-generic-drugs/)

**For any company in the process of preparing and/or submitting a Medical Device submission to FDA, [contact us](https://www.thefdagroup.com/contact) today to ensure you'll be able to make your submission before the new user fees take effect.**

[View full post](https://www.thefdagroup.com/blog/medical-device-submission-filing-fees-are-about-to-rise-significantly)

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