Does this replace the FDA eSTAR template?
No. Always download and use the current official eSTAR from FDA. This tool helps prepare and review the evidence that will support its responses and attachments.
Free FDA submission workpaper · No signup
AI FDA eSTAR Submission Readiness Review
Paste your proposed pathway, device description, indications, predicate strategy and attachment index. The agent builds a submission workpaper showing what appears ready, partial, missing or still dependent on current FDA confirmation.
Paste up to 50,000 charactersEvidence-first agent workflowBranded A4 report
Map submission evidence
The agent separates supplied facts, documents, assumptions and unknowns.
Find missing and partial sections
Every finding stays tied to the evidence you actually supplied.
Prepare an attachment worklist
Turn the result into a practical worklist and save it as a branded PDF.
Review your FDA eSTAR submission readiness
Include the proposed submission type, product code, indications, device description, predicate strategy, testing, software, labeling, and attachment status. Use the current official FDA eSTAR separately.
Separate documents with headings when possible. Do not paste patient-identifying information.0 / 50,000
Privacy: Pure Global does not save this pasted text or the generated report. The text is sent to our AI provider for this one-time analysis. Avoid confidential information you are not authorized to share.
DJ Fang
MedTech Regulatory Expert
Need help confirming a classification or planning your registration?
What to paste for a useful review
State the submission type and known product code, then include the intended use, device features, variants and predicate or De Novo strategy.
Paste an attachment index with report status and conclusions. Do not upload the eSTAR dynamic PDF; use the current official file separately.
Continue your regulatory workflow
Move from this workpaper into the next connected review. Pasted evidence stays on this page and is never placed in a link.
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Frequently asked questions
Can it choose my predicate?
It can review the logic and completeness of a predicate comparison you paste, but it cannot establish substantial equivalence or make the FDA decision.
Which submissions can use eSTAR?
FDA publishes the current mandatory and voluntary uses on the official eSTAR Program page. Confirm the latest submission-specific instructions there.
Does Pure Global save my submission?
Pure Global does not save the pasted text or report. Avoid content you are not authorized to send to the AI provider.