Navigating the FDA approval process for medical devices involves more than technical documentation and testing—it involves significant regulatory costs that manufacturers must plan for early.
Whether you’re submitting a 510(k), Premarket Approval (PMA), or a De Novo request, understanding the latest FDA user fees is essential to budgeting your product development and launch.
This guide breaks down the 2025 Medical Device User Fee Amendments (MDUFA) costs and what you can expect to pay—plus tips for aligning cybersecurity documentation with your submission to avoid costly delays.
What Are FDA User Fees for Medical Devices?
Under the MDUFA program, the FDA collects fees for processing medical device submissions. These fees support review activities, help shorten timelines, and apply to most types of regulatory submissions.
User fees are updated annually and must be paid at the time of submission unless you qualify as a small business (more on that below).
2025 FDA Medical Device User Fees at a Glance
Based on the current FDA MDUFA Fee Schedule, here are the key device submission fees for fiscal year 2025 (Oct 1, 2024 – Sept 30, 2025):
What’s the Difference in Submission Types?
510(k) – Substantial Equivalence
Used for most Class II devices. You must show your device is “substantially equivalent” to a legally marketed predicate device.
- Lower fee
- Most common pathway
- Cybersecurity is increasingly scrutinized here (especially for connected devices)
PMA – Premarket Approval
Used for Class III or high-risk devices. Requires extensive data, including clinical trial results.
- Highest fee due to complexity
- Strong emphasis on cybersecurity risk management, SBOMs, and software validation
De Novo
For novel devices with no predicate but deemed low or moderate risk.
- Mid-range fee
- Often requires a tailored cybersecurity approach since no predicate exists
How to Qualify for Small Business Fee Reductions
You can apply for small business status if:
- You have gross receipts under $100 million
- You submit a Small Business Qualification Request (Form FDA 3602)
If approved, your submission fees can be reduced by up to 75%, a major cost advantage for startups and early-stage innovators.
Don’t Overlook Cybersecurity Costs in FDA Submissions
User fees are only part of the total cost. If your device includes:
- Wireless communication
- Cloud integration
- Mobile apps
- Third-party software
…you’ll also need to include comprehensive cybersecurity documentation, which is now a formal part of FDA’s premarket review under the 2023 Cybersecurity Guidance.
At Blue Goat Cyber, we specialize in:
- Premarket cybersecurity testing and documentation
- SBOM creation and risk assessment
- Support for 510(k), PMA, and De Novo submissions
Pro Tip: Invest in Cybersecurity Early to Avoid Rework
Many companies submit before their cybersecurity artifacts are ready—resulting in RTA (Refuse to Accept) letters, rework, or even resubmission fees.
By integrating cybersecurity into your submission prep, you reduce your total cost of submission and avoid unnecessary delays.
Need Help Preparing for Your FDA Submission?
Blue Goat Cyber helps medical device manufacturers:
- Prepare cybersecurity documentation for FDA 510(k), PMA, or De Novo
- Conduct penetration tests and SBOM reviews
- Align with FDA cybersecurity guidance—without guesswork
👉 Schedule a free consultation today and get submission-ready with confidence.
