The mandatory templates
nIVD and IVD eSTAR v7.1, PreSTAR v3.1 — mandatory for 510(k)s since Oct 2023 and De Novos since Oct 2025, unless exempted.
Free field guide · PDF
FDA eSTAR: Electronic Submissions2026 Field Guide
The mandatory templates, the completeness checks, and the PMA expansion — with the submission practice you need.
- Current template
- v7.1
- Mandatory since
- 2023 / 2025
- PMA draft guidance
- 18 Sep 2026
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 completeness checks
'eSTAR Complete' kills the RTA review for completeness — smart auto-fill, integrated forms, and the portal size limits.
The PMA expansion
The Sep 18, 2026 draft guidance would make eSTAR mandatory for five PMA submission types — with a 60-day comment window.
Sources & scope
- fda.gov, eSTAR Program.
- insider.thefdagroup.com, Draft Guidance Breakdown: FDA Proposes Making eSTAR Mandatory for Certain PMA Submission Types (Sep 2026).
- medium.com/@verusip, Understanding FDA eSTAR (Nov 2025).
This guide is market-access intelligence, not regulatory or legal advice. eSTAR versions, guidance, and reviewer practice change — professional review is required before business use.
Market Access Strategy Session
eSTAR on your 2026 roadmap? Start with the full picture.
A Market Access Strategy Session maps your submission route — template selection, completeness readiness, and the PMA expansion.
Professional review is required before business use.
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