A Pre-Submission is the one point in the process where you can put a specific, open question in front of FDA before you’ve committed months of testing to an assumption. It is optional, it is not binding, and it is one of the most underused tools available to a small regulatory team. Used well, it turns a guess into a documented answer. Used badly, it produces a meeting transcript nobody can act on.
What a Pre-Sub actually is
FDA’s Q-Submission Program covers several request types — Pre-Submissions, Submission Issue Requests, Study Risk Determinations among them — but the Pre-Sub is the one most teams reach for first, because it’s built for early strategy questions: is this the right predicate family, is this test method going to be acceptable, does this labeling claim need clinical data behind it. You send a written package; FDA responds in writing, and for most Pre-Subs you can request a meeting to discuss the response in person or by teleconference.
Preliminary written feedback typically arrives before the meeting itself, which changes what the meeting is for. It is not the first time FDA sees your questions — it’s the chance to clarify an answer that was too brief, or to press on a point where the written response left room to interpret it two ways.
Building the package
- Device description
- Enough detail that a reviewer who has never seen your device can picture how it works and what it contacts. Underspecify here and every later answer gets hedged around the gap.
- Proposed intended use
- Stated the way you intend to claim it on labeling, not a looser internal description. FDA answers the claim you wrote, not the one you meant.
- Proposed regulatory pathway
- Your working theory — candidate predicate, or the performance data you’re planning to generate. You’re not asking FDA to invent your strategy; you’re asking them to react to yours.
- Specific questions
- The actual product of the whole package. Each one should be answerable in a sentence or two. “Is our overall approach acceptable?” is not a question a reviewer can answer usefully.
- Rewrite every question until it can be answered in a sentence or two — not “is this acceptable,” but the specific test, standard, or comparison you need confirmed.
- Include background data only where it changes the answer to a question. A Pre-Sub is not the place to preview your entire file.
- Confirm internally, before you send it, who owns acting on the feedback. An answer nobody follows up on becomes a deficiency later with your name already attached to having asked.
What to expect at the meeting — and after it
Bring the people who will actually act on the answers, not just the people who wrote the questions. If a question is about a test method, the person designing that test should be in the room. Treat anything said in the meeting as useful color, not as the documented outcome — the meeting minutes FDA issues afterward are the record that matters, and they’re what you cite later if a reviewer questions a decision you made based on the feedback. This is a different moment in the process from the interactive review that happens once a file is already in-house — a Pre-Sub happens before you submit, when the goal is still to shape the plan rather than defend a decision already made.
Where teams go wrong
Asking FDA to approve the whole plan
A Pre-Sub isn’t a pre-review of your future submission, and reviewers won’t treat it as one. Bring the two or three questions where a wrong guess is genuinely expensive, and leave the rest for the file itself.
Treating a verbal comment as a commitment
Something said informally in the meeting is not the record. If it matters, ask for it to be reflected in the written minutes before the meeting ends — don’t assume it will be there automatically.
Under-preparing the package
A rushed Pre-Sub gets a shallow answer, because the reviewer can only respond to what’s on the page. If it isn’t ready for the same scrutiny as your eventual 510(k) file, it isn’t ready to send.
Sources & further reading
- FDA — Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program fda.gov
- Regulatory Academy — Building the 510(k): eSTAR, screening, and the testing burden regulatoryacademy.com
- Regulatory Academy — Working with an FDA reviewer during a submission regulatoryacademy.com
This essay is provided for general educational purposes and reflects the regulatory landscape as of its publication date. It is not legal, regulatory, or career advice.
