Free tool · FY2025 fee schedule
Cost Calculator
FDA user fee plus realistic ranges for regulatory consulting, testing, and clinical work. Numbers update annually each October when FDA publishes new fees.
510(k) Premarket Notification · Standard
FDA user fee
$24K
MDUFA V FY2025 fee
Regulatory consulting
$40K - $120K
Regulatory authoring + QMS support
Testing
$50K - $200K
Bench, biocompatibility, EMC, sterility
Clinical
$0 - $0
Most 510(k)s do not require clinical data
Total estimated cost
$114K to $344K
Excludes internal headcount, post-market surveillance, manufacturing scale-up, and inventory. Numbers vary widely by device complexity and team experience.
Compass narrows the range
Your real numbers, not industry averages.
Inside Compass, the calculator pulls your historical consulting rates, your typical testing burden, and your trial design assumptions. The range tightens by 60-80% for sponsors with at least one prior submission on the platform.
Try the sandboxSource: FDA "FY 2025 MDUFA V Fee Schedule" (October 2024). Industry ranges from public consulting market data.
More free tools