The agreement
Agreement in principle 18 March 2026 — FY2027–2032 horizon, $539M user-fee budget, and the reviewer-hiring intent.
Free field guide · PDF
FDA MDUFA VI: User Fee Framework2026 Field Guide
The agreement, the mechanics reset, and the fee structure — with the budgeting practice you need.
- Horizon
- FY27–32
- Agreement
- Mar 2026
- FY27 fees
- $539M
Sourced from verified 2026 publications.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — verified 2026 publications.
The mechanics reset
PreSTAR walkthrough for De Novo, the 'not grantable' second pass, Pre-Sub fee credits, TAP 2.0, and seven codified priorities.
The fee structure
Lower fees for most firms in FY2028 — and the 'America-First' establishment-fee split every manufacturer must watch.
Sources & scope
- baserealitygroup.com, MDUFA VI Just Reset the De Novo and Pre-Sub Mechanics (May 2026).
- mddionline.com, FDA FY 2027 Budget: User Fees Rise, Policy Reforms, Import Rules.
- meddeviceguide.com, FDA 510(k) Fees: MDUFA V User Fee Schedule and Total Cost Breakdown.
This guide is market-access intelligence, not regulatory or legal advice. MDUFA fee schedules, decision goals, and submission mechanics change — professional review is required before business use.
Market Access Strategy Session
FY2027 budgeting on your 2026 roadmap? Start with the full picture.
A Market Access Strategy Session maps your submission strategy — pathway choice, fee planning, and the MDUFA VI mechanics.
Professional review is required before business use.
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