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.
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FDA 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.
Clarify FDA decisions
Start with the product facts and evidence you actually have.
Research relevant public evidence
Separate supplied evidence, public sources, and assumptions.
Strengthen questions and package
Download a branded workpaper with gaps and next actions.
Build an FDA Q-Submission readiness workpaper
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.
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.
DJ Fang
MedTech Regulatory Expert
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How to get a useful workpaper
- 1State the device, intended use, pathway hypothesis, novelty and exact decisions you want from FDA.
- 2Paste draft questions, sponsor positions, predicate comparison, testing plans, available evidence and meeting timing.
Continue from this workpaper
Carry the same product context into a related search, evidence review, or planning task.
FDA Q-Submission & Pre-Submission Readiness Workpaper FAQ
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.
Can I use it before testing is complete?
Yes. State what is planned, underway and complete so the workpaper can identify which assumptions and protocols need FDA feedback.