The two procedures
Direct request vs post-NSE — the §513(f)(2) procedures, the Pre-Sub first move, and what makes the direct route succeed.
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FDA De Novo: Classification2026 Field Guide
The two procedures, the eSTAR mandate, and the 120-day clock — with the classification practice you need.
- Procedures
- 2
- eSTAR mandatory
- Oct 2025
- Classification
- 120 days
Sourced from FDA and verified 2026 publications.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — FDA and verified 2026 publications.
The eSTAR mandate
eSTAR mandatory since 1 October 2025 — the only template, the CDRH Portal route, and the 15-day screening / 180-day correction cadence.
The 120-day clock
FDA must classify by written order within 120 days — the new classification regulation it creates, and the IDx-DR landmark.
Sources & scope
- Federal Register Vol. 91, No. 175 (11 Sep 2026), De Novo classification order.
- fda.gov, De Novo Classification Request.
- intuitionlabs.ai, FDA AI-Enabled Medical Device Authorization Pathways.
This guide is market-access intelligence, not regulatory or legal advice. De Novo practice, guidance, and submission requirements change — professional review is required before business use.
Market Access Strategy Session
De Novo on your 2026 roadmap? Start with the full picture.
A Market Access Strategy Session maps your De Novo strategy — pathway choice, predicate search, and eSTAR readiness.
Professional review is required before business use.
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