Service
Pre-Submission
Fix the pathway and the test plan before you spend on evidence.
What this covers
A Pre-Submission is the point where you ask FDA the questions that decide your budget. Which classification applies. Whether a predicate exists or the device needs De Novo or PMA. Which bench tests, which animal model, and what a first-in-human study has to look like.
We start with the pathway. That means reading the device against the classification regulations, the product codes, and the review division's published decisions, then writing down where it lands and why. If the answer is uncertain, the Pre-Submission is where that uncertainty goes.
We then write the package: device description, intended use, the proposed testing with its rationale, and a short list of specific questions framed so FDA can agree or redirect. We prepare you for the meeting, attend it with you, and draft the minutes.
When you need it
Before an Early Feasibility Study, FDA expects a Pre-Submission. Before a pivotal trial, it is where the endpoints and the statistical plan are agreed. Before a marketing submission, it is where a contested test method gets settled while it is still cheap to change.
What you receive
- Written pathway assessmentClassification, pathway, predicate or reference devices, and the evidence FDA will expect.
- The Q-Submission packageComplete and ready to file, with questions FDA can answer directly.
- Meeting preparation and attendanceA briefing on the review team, a rehearsal, and the meeting itself.
- Draft minutesAs sponsor you must submit meeting minutes within 15 calendar days. We draft them the same day.
- A record of agreementsWhat FDA accepted, what it questioned, and what changes in your plan as a result.
What we need from you
- Device description and design statusDrawings, materials, and what is still changing.
- Draft intended useThe indication and the patient population you want to claim.
- Any testing to dateBench, animal, or prior human experience, in whatever form it exists.
- The questions you are stuck onWhere the team disagrees, or where the answer decides the budget.
Tell us where your program is.
We reply within 12 hours. You get a written scope and estimate before any work starts.