The short answer. A De Novo request costs $191,020 in FDA fees for FY2027 ($47,755 for a qualified small business). FDA’s goal is a decision within 150 FDA days for 90% of requests received in FY2027, but counting the time the company spends answering questions, recent requests took 248 to 278 calendar days on average to reach a decision. FDA grants roughly 30 to 47 De Novo requests a year, and only 40% to 56% of the requests it decides end in a grant.
Fee
| FY2027 | FY2026 | |
|---|---|---|
| Standard fee | $191,020 | $173,782 |
| Small business fee | $47,755 | $43,446 |
Small business status requires gross receipts of $100 million or less and an approved request on Form FDA 3602N; see FDA medical device user fees for FY2027 for the process.
FDA’s review goal
Under MDUFA V the goal started at a decision within 150 FDA days for 70% of requests and stepped up because FDA met the earlier targets: 80% for FY2026 and 90% for FY2027. The draft MDUFA VI letter keeps 150 FDA days for 90% from FY2028 to FY2032.
What actually happened
| Measure (CDRH, by year of receipt) | FY2023 | FY2024 | FY2025 (open) | FY2026 (open) |
|---|---|---|---|---|
| Requests received | 96 | 78 | 68 | 48 |
| Refused at acceptance or failed screening, first cycle | 30.1% | 14.3% | 10.6% | 6.5% |
| Decided within 150 FDA days | 94.0% | 98.6% | 92.0% | 100% (3 of 3) |
| Average FDA days | 131 | 121 | 132 | 98 |
| Average company days | 139 | 126 | 146 | 12 |
| Average total days to decision | 270 | 248 | 278 | 110 |
| Granted / declined / withdrawn / deleted | 37 / 18 / 17 / 11 | 29 / 18 / 13 / 12 | 28 / 7 / 5 / 10 | 1 / 1 / 1 / 0 |
| Grant rate among decided requests | 44.6% | 40.3% | 56.0% |
| Year | De Novo requests granted |
|---|---|
| 2021 | 30 |
| 2022 | 23 |
| 2023 | 47 |
| 2024 | 47 |
| 2025 | 27 |
| January to September 2026 | 26 |
Acceptance review and eSTAR
- FDA completes the acceptance review within 15 calendar days; if it does not, the request is accepted for substantive review automatically. If FDA refuses to accept, you have 180 days to send a complete response or the request is considered withdrawn.
- Since October 1, 2025, De Novo requests must be submitted as an eSTAR. FDA runs a technical screening within 15 calendar days of receipt.
- As the table shows, first-cycle refusals fell from 30% of requests received in FY2023 to 7% in FY2026.
What the numbers mean for a De Novo plan
The FDA review itself is fairly predictable; the variable is the company’s time to answer questions, which on average is as long as FDA’s. Budget eight to nine months from submission to decision, not five. In engineering terms, the requests that move fastest arrive with the risk analysis, performance testing and special controls proposal already complete. If your device might fit a 510(k) with a suitable predicate, compare both paths early: the De Novo fee alone is almost seven times the 510(k) fee, and see 510(k) review times in 2026.
Sources
- Federal Register: Medical Device User Fee Rates for Fiscal Year 2027
- FDA: MDUFA fees, current as of October 1, 2026
- FDA: MDUFA Performance Goals and Procedures, FY2023 to FY2027
- FDA: MDUFA V quarterly performance report, actions through June 30, 2026
- FDA guidance: Acceptance Review for De Novo Classification Requests (October 2021)
- FDA guidance: Electronic Submission Template for De Novo Requests (August 2024)
- FDA De Novo database
- FDA: draft MDUFA VI commitment letter (July 7, 2026)
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.