Free FDA meeting-preparation tool · No signupFDA Q-Submission & Pre-Submission Readiness Workpaper
A useful Q-Submission is a decision package, not a list of broad questions. Structure the feedback you need from FDA and identify the evidence, alternatives, and missing context needed to make each question answerable.
Free · no loginStructured outputPaste up to 50,000 charactersCurrent-source checks when useful
Paste your product, proposed pathway, evidence plan, FDA questions, and meeting objectives
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The review structures the decision you need from FDA, researches current public FDA material, and identifies gaps that could prevent useful written feedback or a productive meeting.
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What to paste for a useful review
State the device, intended use, pathway hypothesis, novelty and exact decisions you want from FDA.
Paste draft questions, sponsor positions, predicate comparison, testing plans, available evidence and meeting timing.
- What should I ask FDA in a Pre-Sub?
- Ask focused questions tied to a real decision, give the sponsor position and rationale, and provide enough device and evidence context for FDA to respond.
- Can this select my predicate?
- It can research comparable public records and expose comparison gaps, but final predicate and submission strategy require accountable review.
- Does it create a complete Q-Sub package?
- It creates a readiness workpaper and action list, not a submission-ready controlled document.
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