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2026 FDA 510(k) Budget Planner

A two-page worksheet for organizing your 510(k) submission budget — FY2026 FDA fee figures, typical third-party cost categories, and a blank column to track quotes as you get them. Enter your email below and the download link appears immediately.

What's Inside

FY2026 FDA establishment registration fee, sourced from FDA's published fee schedule
Where to find FDA's current 510(k) (MDUFA) user fee — updated every October
Typical third-party cost categories: bench testing, biocompatibility, software/cybersecurity documentation, sterilization validation, and more
ADB's published flat-fee tiers for reference
A blank worksheet column to record your own vendor and consulting quotes

The download link is not secret — this form exists so we can occasionally follow up with useful FDA regulatory resources, not to restrict access.

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Flat-fee review of your device documentation against FDA's 510(k) content expectations.

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Understand FDA's review clock and what drives real-world timeline variance.

2026 FDA 510(k) Budget Planner

What's Inside

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