The short answer. In fiscal year 2027 (October 1, 2026 to September 30, 2027) a 510(k) costs $28,653 in FDA user fees, or $7,163 for a small business with an approved Small Business Determination. Add up below what you will pay for a 510(k), De Novo, PMA, 513(g), supplements and the annual establishment registration. The amounts come from the FDA notice in the Federal Register of July 30, 2026.
How this works
- Rates. Each fee is the FY2027 amount published by FDA. You pay the fee for the fiscal year in which you send the submission.
- Small business. A business with gross receipts or sales of $100 million or less, including affiliates, pays reduced fees once FDA approves its Small Business Determination: 25% of the standard fee for most submissions and 50% for 30-day notices and 513(g) requests.
- First PMA. A business with $30 million or less pays no fee for its first PMA, PDP, BLA or premarket report.
- Registration. The annual establishment registration fee has no small business rate. FDA may waive the annual fee, not the initial one, for a business with $1 million or less in gross receipts if paying it is a financial hardship; FDA says the only situation it currently knows that meets this is active bankruptcy.
FDA user fees for FY2027
| Submission | Standard fee | Small business fee |
|---|---|---|
| 510(k) premarket notification | $28,653 | $7,163 |
| De Novo classification request | $191,020 | $47,755 |
| PMA, PDP, PMR, BLA (original) | $636,732 | $159,183 |
| Panel-track supplement | $509,386 | $127,347 |
| 180-day supplement | $95,510 | $23,878 |
| Real-time supplement | $44,571 | $11,143 |
| 30-day notice | $10,188 | $5,094 |
| 513(g) request for classification information | $8,596 | $4,298 |
| Annual fee for periodic reporting (Class III) | $22,286 | $5,572 |
| Annual establishment registration | $13,785 | no reduced rate |
What is not included
- Test labs (electrical safety, EMC, biocompatibility), clinical studies and consultants. These are usually larger than the FDA fee.
- The engineering to get the device ready for a submission. Our cost calculator estimates it by phase.
- Fees outside the US, for example EU notified body fees, and other FDA programs.
What OVA does here, and where our responsibility ends
OVA Solutions is a medical device engineering group working under an ISO 13485:2016 certified quality system: 62 engineers, 220 devices developed, $125 per hour. We design electronics, firmware and mechanics and take a device from concept to design for manufacturing. We are not a regulatory consultancy and not a contract manufacturer: the regulatory strategy and the submission stay with you or your regulatory consultant.
The result is an orientation, not a regulatory opinion. Confirm the pathway and the fees with a regulatory specialist or through a Pre-Submission (Q-Sub) with FDA. The tool runs in your browser. Your answers are not sent to us; with your cookie consent, Google Analytics records only that the tool was used and the category of the result.
Questions
What is the FDA 510(k) fee for FY2027?
The standard fee is $28,653. A small business with an approved Small Business Determination pays $7,163. The FY2027 rates apply to submissions FDA receives from October 1, 2026 to September 30, 2027.
Who counts as a small business for FDA user fees?
A business whose gross receipts or sales, including all affiliates, were $100 million or less in the most recent tax year. It pays reduced fees only after FDA approves its Small Business Determination request.
Is the establishment registration fee reduced for small businesses?
No. The annual establishment registration fee is $13,785 for everyone in FY2027. FDA may waive the annual fee for a business with $1 million or less in gross receipts if paying it is a financial hardship, and says the only case it currently knows that meets this is active bankruptcy.
How much is the De Novo fee?
The standard De Novo fee for FY2027 is $191,020; the small business fee is $47,755.
Does the calculator include the cost of developing the device?
No, only the FDA user fees. The engineering behind a submission is usually much larger; the cost calculator on this site estimates it by phase.
Related pages
Sources
- Federal Register: Medical Device User Fee Rates for Fiscal Year 2027 (2026-15335), July 30, 2026
- FDA: Medical Device User Fee Amendments (MDUFA) fees
- FDA: Medical Device User Fees (payment and incomplete applications)
- FDA: Reduced or Waived Medical Device User Fees, Small Business Determination (SBD) Program, content current as of September 21, 2026
Data as of October 1, 2026. By Lisa Voronkova, CEO of OVA Solutions. Updated on October 22, 2026.