Which pathway fits your device
Class I, II, III — and the decision tree: predicate with substantial equivalence means 510(k), novel low-to-moderate risk means De Novo, high-risk means PMA.
Free field guide · PDF
FDA Medical Device Approval2026 Field Guide
What manufacturers need to know before entering the US market — the 510(k), De Novo, and PMA pathways, FY2026 fees, and how the review clock really runs.
- 510(k) decision goal
- 90 days
- FY2026 510(k) fee
- $26,067
- 510(k)s cleared / yr
- ~3,200
Sourced from MDUFA V fee schedules and 2026 regulatory analyses.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — MDUFA V schedules and 2026 regulatory analyses.
What it costs in FY2026
FY2026 MDUFA V fees: $26,067 standard 510(k) ($6,517 small business), $11,423 annual establishment registration — plus what the fee doesn't cover.
How the clock really runs
90 FDA days is not 90 calendar days, eSTAR is mandatory, and since February 2026 the QMSR incorporates ISO 13485 — what actually moves the timeline.
Sources & scope
- MedDeviceGuide, FDA 510(k) fees: MDUFA V user fee schedule (FY2026).
- Base Reality Group, the FDA review clock and MDUFA commitments — July 2026.
- IntuitionLabs, FDA 510(k) premarket notification process overview.
- CitrusBits, SaMD FDA approval essentials for 2026 and beyond.
This guide is market-access intelligence, not legal or regulatory advice. FDA fees and timelines change — professional review is required before business use.
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