The short answer. For FDA 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 qualified small business. A De Novo request costs $191,020 ($47,755 small business), an original PMA $636,732 ($159,183), and every establishment pays a $13,785 annual registration fee with no small business discount. Submission fees rose about 9.9% over FY2026; the registration fee rose 20.7%.
| Submission | FY2027 standard | FY2027 small business | FY2026 standard | FY2026 small business |
|---|---|---|---|---|
| 510(k) premarket notification | $28,653 | $7,163 | $26,067 | $6,517 |
| De Novo classification request | $191,020 | $47,755 | $173,782 | $43,446 |
| PMA, PDP, PMR, BLA (original) | $636,732 | $159,183 | $579,272 | $144,818 |
| Panel-track supplement | $509,386 | $127,347 | $463,418 | $115,855 |
| 180-day supplement | $95,510 | $23,878 | $86,891 | $21,723 |
| Real-time supplement | $44,571 | $11,143 | $40,549 | $10,137 |
| 30-day notice | $10,188 | $5,094 | $9,268 | $4,634 |
| 513(g) request for classification information | $8,596 | $4,298 | $7,820 | $3,910 |
| Annual fee for periodic reporting (Class III) | $22,286 | $5,572 | $20,275 | $5,069 |
| Annual establishment registration | $13,785 | no reduced rate | $11,423 | no reduced rate |
The fee that applies is the one in force on the later of two dates: the day FDA receives the submission or the day the U.S. Treasury recognizes the payment. A 510(k) sent through an FDA-accredited third-party reviewer has no FDA user fee (FDA third-party review program).
Why the registration fee jumped 20.7%
The FY2027 notice adds a performance improvement adjustment of $63,542,885 to registration fees only. FDA earned it because it met two MDUFA goals: the FY2025 Pre-Submission written feedback goal and the FY2024 De Novo decision goal. The statutory base amounts for FY2027 are $470,000 for a premarket application and $8,465 for registration; inflation and other adjustments bring them to the published rates.
Small business rates and who qualifies
| Gross receipts or sales (most recent tax year, including affiliates) | What you get |
|---|---|
| $100 million or less | Reduced fees: 25% of the standard fee for most submissions, 50% for 30-day notices and 513(g) requests |
| $30 million or less | The fee for your first PMA, PDP, BLA or premarket report is waived |
| $1 million or less | The annual registration fee may be waived for financial hardship (not the initial registration); apply between August 2 and November 1 |
How to get small business status for FY2027
- Submit a Small Business Request on Form FDA 3602N through the CDRH Portal. Paper or mailed requests are not accepted. Foreign firms submit a certification from their national taxing authority instead of a U.S. tax return.
- FY2027 requests are accepted from August 2, 2026 through August 1, 2027. FDA aims to decide within 60 calendar days, so apply at least 60 days before you pay a fee.
- Pay the reduced fee only after you receive your SBD number. FDA does not refund the difference if you paid the standard fee first.
- Status lasts one fiscal year: FY2026 status expired on September 30, 2026, and must be renewed each year.
What these fees mean for a development budget
FDA fees are a small part of a device program next to engineering and testing, but they are fixed and due at submission, so plan them with the timeline. A Class II device going through 510(k) typically carries one 510(k) fee plus the yearly registration once you list the device. A novel low to moderate risk device going De Novo pays almost seven times the 510(k) fee. For the engineering side of the budget, see what medical device development costs and our page on 510(k) review times in 2026.
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, current as of October 1, 2026
- Federal Register: Medical Device User Fee Rates for Fiscal Year 2026 (2025-14412), July 30, 2025
- FDA: Reduced or Waived Medical Device User Fees, Small Business Determination (SBD) Program
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, offices in New York, Florida, the United Kingdom, Estonia and Ukraine. 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.
More from OVA: what medical device development costs, how to choose a development firm, answers from Lisa Voronkova, our quality system.
Updated on October 8, 2026.