Cahir MedTech · Free video walkthrough
How CDRH Reviewers Actually Read Your Question Matrix
In about 4 minutes, explore how to frame focused Pre-Submission questions — so you can seek feedback that informs your test plan.
- What makes a question specific, bounded and answerable
- Weak vs. strong rewrites for testing, clinical and AI/ML questions
- Red flags that lead to vague or non-committal feedback
Illustrative educational walkthrough, not an FDA meeting recording or FDA-endorsed training. On-screen captions with background music; no narration.
The 5-question reviewer checklist
- Is the question specific — one topic, one decision FDA can address?
- Does it state your proposed approach rather than asking what FDA wants?
- Is the rationale and supporting data summarized and clearly referenced?
- Is the scope bounded to this device, indication and test plan?
- Have you prioritized a manageable number of topics for focused feedback?
Frequently asked questions
What is a question matrix in an FDA Pre-Submission?
It is the organized list of specific questions a sponsor asks FDA in a Pre-Submission, each paired with the sponsor's proposed approach and supporting rationale. FDA's Q-Submission Program guidance asks sponsors to frame specific questions so the review team can give focused written feedback.
How many questions should a Pre-Submission include?
FDA's Q-Submission guidance recommends keeping the request to a manageable number of topics so the review team can address each one meaningfully. Grouping related issues and prioritizing the decisions that affect your test plan works better than a long list.
Why do open-ended questions get weak FDA feedback?
Asking what FDA wants gives the reviewer nothing to agree or disagree with. A question that proposes a specific method, sample size or endpoint, with a rationale, lets FDA confirm it or say what is missing — which is the feedback you can actually plan around.
Is the walkthrough video free?
Yes. Anyone can play the walkthrough without registering. An optional work-email form provides a free one-page companion summary PDF. The FDA Q-Sub Master Pack is a separate one-time purchase.
Source: FDA — Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program