Pre-Sub Question Tester
Test draft Q-Submission questions against FDA guidance before the meeting request goes in.
Zero-Transmission Regulatory Privacy Architecture
Pre-Submission questions disclose your unannounced device strategy, pipeline timing, and regulatory vulnerabilities. This tool runs 100% locally in your browser memory. Nothing you paste or type leaves your machine. No server calls, no telemetry on text, no persistence.
Why Pre-Submission Questions Fail: Appendix 2 Deconstructed
The Q-Submission Program (FDA-2018-D-1774) is the most powerful mechanism for de-risking interventional and diagnostic medical device development. However, FDA reviewers frequently remark that meetings produce limited value because applicants submit questions that reviewers are prohibited or unable to answer.
1. The Ultimate Determination Trap
Reviewers cannot grant marketing clearance, find substantial equivalence (SE), or declare a device safe and effective during a Pre-Sub. Asking "Will this test protocol prove substantial equivalence?" forces FDA to issue a pro-forma refusal: "A determination of substantial equivalence cannot be made until a complete 510(k) is submitted and reviewed." Instead, ask whether FDA agrees that the selected test methods and acceptance criteria adequately address the specific mechanism-of-action risk.
2. The Unstated Position Flaw
An open-ended question such as "What animal model should we use?" or "How many fatigue cycles are required?" invites the most conservative, burden-heavy recommendation FDA can make. Under the Least Burdensome Provisions (Section 513(a)(3)(D)), you must propose your position first with engineering and standard rationale (e.g., ISO 10993 or ASTM F2077), then ask: "Does FDA agree with this proposed rationale? If not, what specific concerns exist?"
3. Multi-Part Question Cascades
Combining multiple complex questions under sub-letters (e.g., 1a, 1b, 1c, 1d) circumvents the guidance's recommended 10-question ceiling and leads to superficial responses. Reviewers allocate fixed preparation time; three deeply justified, anchored questions yield significantly higher strategic clarity than fifteen fragmented queries.
Questions we get
Why does FDA reject or refuse to answer certain Pre-Sub questions?
FDA will not answer questions asking for an ultimate regulatory determination (such as whether a device is substantially equivalent or safe and effective), questions asking FDA to design your study or test protocol, or open-ended questions lacking a proposed applicant position. Pre-Subs exist to provide feedback on specific proposed plans, not to make marketing decisions or ghostwrite device development.
What is the recommended limit on questions in a Q-Submission?
FDA guidance (Section II.A) explicitly recommends no more than 7 to 10 questions, including sub-questions, focused on no more than 3 to 4 substantial topic areas. Exceeding these thresholds causes review fatigue and increases the risk that FDA cannot address your core priorities during the meeting.
What distinguishes a "Guidance" finding from a "Craft" finding in this tool?
A "Guidance" finding directly cites an explicit principle or worked example from FDA's Q-Submission guidance document (FDA-2018-D-1774, Appendix 1 or Appendix 2). A "Craft" finding reflects seasoned RA/QA industry practice and empirical review experience; it is our professional opinion, and FDA guidance does not formally mandate it.
Does this tool transmit or store my questions?
No. The evaluation engine runs entirely in client-side JavaScript within your browser session. Zero data is transmitted, cached on a server, or logged to analytics.
Does a Pre-Submission assure 510(k) clearance or PMA approval?
No. Feedback received in a Pre-Sub is non-binding on both FDA and the applicant, though it is formally documented in meeting minutes. FDA cannot determine substantial equivalence or approve a device until the full marketing submission is formally reviewed.
Limited intake
Preparing a Complex Q-Sub or Formal FDA Submission?
Our regulatory engineering alliance provides independent Pre-Sub reviews, DHF gap analysis, and 510(k) eSTAR compilation.