Free FDA submission workpaper · No signupAI 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.
Free · no loginStructured outputPaste up to 50,000 charactersCurrent-source checks when useful
Paste your device profile and submission-content index
Try an example
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 publish this pasted text or generated workpaper. It is processed for this review and sent to our AI provider. Avoid patient-identifying information and confidential material you are not authorized to share.
About this agent
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.
- 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.
- 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.
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