How Do I Request a Pre-Submission Meeting With FDA and What Goes in the Package?

FDA's Q-Submission Program, described in the agency's guidance "Requests for Feedback and Meetings for Medical Device Submissions," gives sponsors a formal channel to get FDA's position on a regulatory strategy, a testing plan, or a predicate comparison before committing to a full submission. Used well, a Pre-Sub turns open questions into agreed positions. Used poorly, with vague questions or an incomplete package, it produces feedback too general to rely on.

What a Pre-Submission Is, and When to Use One

A Pre-Sub is not a preliminary review of the device; FDA does not clear or approve anything at this stage. It is a structured opportunity to ask specific questions and receive FDA's written position, either through a written response alone or a meeting followed by written minutes. Use one when a predicate comparison is genuinely uncertain, when a novel technology has no established testing standard, when a clinical study design needs FDA agreement before enrollment begins, or when a classification pathway itself is ambiguous enough that a 513(g) alone will not resolve it. Skip a Pre-Sub when the device follows a well established predicate and testing pattern with no open questions worth FDA's formal position; in that case, a Pre-Sub adds 70 or more days without resolving genuine uncertainty.

What Goes in the Pre-Submission Package

FDA's guidance describes a standard package structure, and an incomplete package is the most common reason a Pre-Sub request is placed on hold before the clock even starts. A complete package includes:

• Cover letter. Identifies the device, the submission type anticipated, and states plainly that this is a Pre-Submission request under the Q-Submission Program.
• Device description. Technology, intended use, indications for use, and how the device functions, detailed enough for FDA reviewers to evaluate the specific questions asked.
• Proposed indications for use. The exact indications the sponsor intends to pursue, since FDA's feedback is tied to this specific scope.
• Regulatory history. Prior FDA interactions on this device or a predecessor, including any previous Pre-Subs, so reviewers have full context.
• Proposed testing or clinical plan. The specific nonclinical and, where relevant, clinical testing the sponsor proposes, since most Pre-Sub questions concern whether this plan will support the intended submission.
• Specific questions. A numbered list of discrete questions FDA is asked to answer, the single most important element of the package.

How to Write Questions FDA Can Actually Answer

FDA's own guidance is explicit that vague, open-ended questions receive vague, open-ended answers. A question like "Is our regulatory strategy appropriate?" invites a noncommittal response. A question like "Does FDA agree that Predicate X supports a substantial equivalence claim for Indication Y, given Difference Z in technological characteristics?" invites a specific, usable answer. Each question should state the sponsor's own proposed position and ask FDA to agree, disagree, or clarify, rather than asking FDA to generate the position from nothing.

The 70 to 75 Day Window and Meeting Format

Once FDA accepts a Pre-Sub request as complete, the agency targets a response within 70 to 75 calendar days, the clock running from acceptance, not from the original submission date if the package required correction first. FDA may respond in writing alone for narrower questions, or schedule a meeting, typically by teleconference, for questions that benefit from discussion. When a meeting is scheduled, FDA provides written preliminary feedback in advance, and the meeting itself focuses on clarifying that feedback rather than introducing new material; sponsors who arrive expecting to present a full case, rather than to discuss FDA's preliminary answers, often find the meeting time runs out before their own questions are revisited.

What to Do With FDA's Written Feedback

FDA's written feedback, whether delivered alone or as meeting minutes, becomes the agreed starting position for the eventual submission. Any later deviation from that feedback needs its own explanation and justification in the submission itself, since FDA reviewers checking the final package against the Pre-Sub record will treat an unexplained departure as a new, unresolved question rather than settled ground. Treat the feedback as a commitment the sponsor is making to FDA, not just information FDA is giving the sponsor.

ADB's regulatory team drafts the full Pre-Submission request letter and briefing package, including the specific question set, as part of the Pre-Sub Strategy and Briefing Package service.

Frequently Asked Questions

How long does FDA take to respond to a Pre-Submission request?

FDA targets written feedback or a meeting within 70 to 75 calendar days of accepting the Pre-Submission request, measured from the date FDA confirms the request is complete, not the date it was first submitted.

Is a Pre-Submission meeting mandatory before a 510(k) or PMA?

No. A Pre-Submission is voluntary. It is strongly advisable when the device is novel, the predicate comparison is uncertain, or the testing plan involves judgment calls FDA could reasonably disagree with, since confirming the approach before submission avoids an Additional Information cycle after the fact.

What should I do with FDA's written feedback after a Pre-Sub?

Treat it as the agreed starting position for the eventual submission. Any deviation from the feedback in the final submission should be explained and justified, since FDA reviewers checking the submission against the Pre-Sub minutes will flag an unexplained departure as a new, unresolved question.