The short answer. FDA’s goal is a decision on 95% of 510(k)s within 90 FDA days, and it meets it: 97.9% of submissions received in FY2025 were decided on time. But FDA days stop counting while the company answers questions. Counting everything, a 510(k) received in FY2025 took on average 141 calendar days to a decision (76 FDA days plus 66 days of the company’s own time). The median cleared 510(k) in calendar 2025 took 126 days from receipt to clearance: 142 days for a traditional 510(k), 30 days for a Special 510(k).
FDA’s goals for 510(k) review (MDUFA V, FY2023 to FY2027)
| Step | Goal |
|---|---|
| Acceptance review or eSTAR technical screening | Within 15 calendar days of receipt |
| Substantive Interaction (first questions or no questions) | Within 60 calendar days for 95% of submissions |
| MDUFA decision | Within 90 FDA days for 95% of submissions |
| Written feedback if no decision | By day 100 of FDA time |
| Average total time to decision (FDA plus company time) | 112 calendar days for submissions received in FY2025 to FY2027 (128 in FY2023, 124 in FY2024) |
What actually happened: FDA performance data
| Measure (CDRH, by year of receipt) | FY2023 | FY2024 | FY2025 | FY2026 (open) |
|---|---|---|---|---|
| 510(k)s received | 3,857 | 3,554 | 3,966 | 2,781 |
| Refused at acceptance or failed screening, first cycle | 20.5% | 5.4% | 7.2% | 8.7% |
| Decided within 90 FDA days (goal 95%) | 99.3% | 98.8% | 97.9% | 97.6% |
| Average FDA days to decision | 75 | 75 | 76 | 67 |
| Average company days (answering questions) | 66 | 69 | 66 | 19 |
| Average total days to decision | 141 | 144 | 141 | 87 |
| 80th percentile total days | 238 | 243 | 237 | 126 |
| Average review cycles | 1.67 | 1.69 | 1.69 | 1.46 |
| Substantially equivalent decisions | 95.5% | 95.3% | 95.8% | 98.7% |
The official shared goal for average total time to decision was met for FY2023 (127 days against 128) and missed for FY2024 (139 days against 124), according to FDA’s FY2025 report to Congress. That official figure trims the slowest and fastest 2% and includes third-party and CBER files, so it differs slightly from the table above.
Calendar days from submission to clearance
| Period | Cleared 510(k)s | Median days | Average days |
|---|---|---|---|
| Calendar 2024 | 3,082 | 129 | 159 |
| Calendar 2025 | 3,198 | 126 | 146 |
| Calendar 2025, traditional 510(k) | 2,655 | 142 | |
| Calendar 2025, Special 510(k) | 481 | 30 | |
| FY2026 (October 2025 to September 2026) | 3,277 | 131 | 151 |
Where the time goes
- Days 1 to 15: screening. Since October 1, 2023, every 510(k) must be an eSTAR. Instead of the old Refuse to Accept checklist, FDA runs a technical screening within 15 days. A failed screening puts the file on hold; you have 180 days to send a complete replacement.
- By day 60: Substantive Interaction. In about two out of three files this is an Additional Information request (66% for the FY2025 cohort, 68% for FY2024, calculated from FDA’s annual report counts). The FDA clock stops until you answer, and you have 180 days.
- Decision. After your response FDA has the rest of its 90 FDA days. Most files need one or two review cycles (1.69 on average).
The company’s own time is the part you control. On average it is almost as long as FDA’s review: 66 days out of 141. From the engineering side the usual causes are testing that was not finished before submission (electrical safety and EMC to IEC 60601, biocompatibility to ISO 10993, software documentation to IEC 62304), and a weak comparison to the predicate. A test report you still have to order adds weeks, because labs book in advance.
Third-party review
An FDA-accredited third-party reviewer can review eligible 510(k)s; FDA then decides within 30 days of receiving the recommendation, and FDA charges no user fee (the reviewer charges its own). It is used for a small share of files: 67 accepted in FY2025.
| Third-party review | FY2023 | FY2024 | FY2025 | FY2026 (open) |
|---|---|---|---|---|
| Submissions | 77 | 68 | 67 | 63 |
| FDA decision within 30 days | 87% | 84% | 71% | 93% |
| Median days from third-party receipt to decision | 109 | 126 | 116 | 76 |
What changes after 2027
The draft MDUFA VI commitment letter for FY2028 to FY2032 (July 7, 2026) keeps the goal of 95% of 510(k) decisions within 90 FDA days and restarts the average total time goal at 128 days in FY2028, falling to 112 days by FY2032. It is a draft until Congress reauthorizes the user fee program.
Sources
- FDA: MDUFA Performance Goals and Procedures, Fiscal Years 2023 Through 2027
- FDA: Quarterly Update on Medical Device Performance Goals, MDUFA V, actions through June 30, 2026
- FDA: MDUFA Performance Report to Congress, FY2025
- FDA: MDUFA Performance Report to Congress, FY2024
- FDA guidance: Electronic Submission Template for Medical Device 510(k) Submissions (October 2023)
- FDA guidance: Refuse to Accept Policy for 510(k)s (April 2022)
- FDA: 510(k) Third Party Review Program
- FDA: Third Party Review Organization Performance Report, FY2026 Q3
- openFDA: device 510(k) endpoint (data updated September 28, 2026)
- FDA: draft MDUFA VI commitment letter (July 7, 2026)
- FDA: list of MDUFA performance reports
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.