FDA Pre-Submissions (Q-Subs): Program Overview, Expected Feedback, and Common Team Mistakes

For device sponsors, the Pre-Submission meeting is one of the few opportunities to receive documented FDA feedback before committing resources to a pivotal study or a marketing application. How a team structures that interaction—and whether the questions posed are specific enough to generate actionable responses—often determines whether the exchange advances the program or simply consumes a review cycle.

The analysis below covers how the Q-Submission program is structured, what types of feedback and timelines sponsors should expect, and the recurring preparation and drafting errors that reduce the utility of the interaction, drawing on FDA's May 2025 final guidance and the March 2024 draft that preceded it.

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FDA Pre-Submissions (Q-Subs): what they are, what feedback you get, and where teams go wrong

The Pre-Submission is the single most useful interaction most device teams will ever have with FDA, and also the one most often wasted. Used well, it converts an open regulatory question into documented Agency feedback before a company commits budget to a pivotal study or a marketing application. Used poorly, it burns a review cycle and returns feedback too vague to act on. This overview explains what a Pre-Sub is within the broader Q-Submission (Q-Sub) framework, the feedback and timelines a sponsor can expect, and the recurring mistakes that reduce the value of the interaction, drawn from FDA's guidance "Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program" (final guidance issued May 2025, and the March 2024 draft that preceded it).

What the Q-Submission program is

The Q-Submission (Q-Sub) program is FDA's mechanism for tracking interactions in which a submitter requests feedback and/or a meeting with the Agency outside of an IDE, IND, marketing submission, Accessory Classification Request, or CW submission 822. It is voluntary, it is used at multiple points across device development and premarket preparation, and it creates a documented record of the exchange between the sponsor and the review division 822.

The Q-Sub is an umbrella, not a single product. The types tracked under it include 101115172024:

  • Pre-Submission (Pre-Sub) 1124
  • Submission Issue Request (SIR) 10
  • Informational Meeting 2022
  • Study Risk Determination Request 2734
  • PMA Day 100 Meeting 2728
  • Interactions tied to the Breakthrough Devices Program (including Breakthrough Device Designation Requests) and the Safer Technologies Program (STeP) 1517
  • Accessory Classification Requests, Early Collaboration Meetings under FDAMA (agreement and determination meetings), and Combination Product Agreement Meetings (CPAM) 151720
  • Other interactions with no dedicated Q-Sub type, which FDA may track using the Informational Meeting mechanism 1720

What a Pre-Submission actually is

A Pre-Sub is a formal, written request for FDA feedback in advance of an intended submission 1124. The Agency delivers that feedback either as formal written feedback only, or as written feedback followed by a meeting 411. Its purpose is narrow and specific: to obtain FDA input on defined questions that will guide product development and submission preparation 1124.

Equally important is what a Pre-Sub is not. FDA is explicit that it is not a pre-review of an intended submission, and not a pre-review of the data you plan to include in that submission 1124. That single distinction explains most of the friction teams experience.

A Pre-Sub is appropriate when FDA feedback on specific questions would help guide development or submission preparation for a planned IDE, IND, CW, Accessory Classification Request, or a marketing submission such as a PMA, HDE, De Novo request, 510(k), Dual, or BLA 1124. FDA recommends keeping any single Pre-Sub targeted and focused, with clear questions and enough background to support meaningful feedback, and it advises no more than three to four substantial topics per submission 1823. When a question is better suited to informal communication, FDA suggests contacting the review division or OPEQ Submission Support to find the right pathway rather than defaulting to a Pre-Sub 2224.

The feedback sponsors receive, and the timelines

For an accepted Pre-Sub, FDA commits to providing written feedback by 70 days after receipt, or 5 days before a scheduled meeting, whichever is sooner 3031. If the sponsor requested a meeting, it is held on a mutually agreed date, generally around day 70 to 75 3031. In the guidance's own table, the Pre-Sub is described as a "meeting with written feedback provided in advance" 3031.

Two properties of that feedback are essential to understand:

  • It is nonbinding. The guidance carries the standard "Contains Nonbinding Recommendations" label, and FDA is clear that Pre-Sub feedback does not obligate the sponsor to resolve every issue in a later submission, does not guarantee a favorable future decision, and does not prevent FDA from raising additional questions when the full submission is reviewed or when new information emerges 447. If a sponsor later chooses a different approach than the one discussed, the subsequent submission should explain why 47.
  • It can expire in practice. If more than a year has passed since FDA gave feedback on significant study-design topics and the study has not started, FDA recommends the sponsor confirm the advice still applies; a new Pre-Sub may be warranted 10.

If a sponsor's questions are fully answered in the written feedback, the sponsor may cancel the meeting 13330.

The meeting-minutes process

For a Pre-Sub meeting, the submitter, not FDA, drafts the meeting minutes and submits them to FDA for review within 15 days of the meeting; the sponsor should assign a team member to take minutes during the meeting 5759. FDA reviews the draft. If FDA has no edits, the minutes become final; if FDA revises them, it returns a revised version, which becomes final absent a disagreement 571659. Minutes should summarize discussion, agreements, resolutions, and action items rather than serve as a transcript 5716.

Meeting logistics

FDA's practical expectations for the meeting itself include submitting draft slides electronically at least 2 days before the meeting so staff can review them, keeping meetings to roughly 1 hour, and coordinating any external attendees the sponsor wants to include 58605. FDA notes that a virtual meeting is typically the most efficient format and the easiest to schedule promptly 58. New information provided too late for FDA to review will generally not be addressed at the meeting 5860.

What teams get wrong

The failure modes below come directly from FDA's own descriptions of ineffective or out-of-scope requests.

Too many questions and too many topics. FDA states that the most effective Pre-Subs typically contain no more than 7 to 10 questions across no more than four substantial topics; beyond that, feedback becomes less productive and dependent questions become hard for FDA to answer clearly 43. When a Pre-Sub is overloaded, FDA may tell the sponsor to prioritize certain topics and defer the rest to later Pre-Subs 1823.

Treating it as a data pre-review. Requests for a pre-review of data are not appropriate for a Pre-Sub 43. This is the most common category error: sponsors submit datasets hoping for an advance verdict, which is outside the Pre-Sub's purpose 112443.

Asking FDA to design the study. FDA does not design or prepare study plans for sponsors due to resource constraints 43. If a sponsor wants feedback on a protocol, it must supply a proposed protocol outline with a rationale for the approach; without directed questions about that protocol, FDA's feedback tends to be too general to be useful 43.

Using a Pre-Sub for classification questions. Requests about a device's classification and the regulatory requirements that apply to it are not within Pre-Sub scope; those belong in a 513(g) Request for Information 45.

Asking questions out of sequence (premature questions). Where the answer to one question depends on another, FDA warns it can be premature to ask about performance testing before intended use and the regulatory pathway are settled, or to ask about a clinical protocol before the indications for use and the supporting non-clinical data are defined 45. If the device is still evolving and technological changes are expected, questions about performance testing may be premature 45. FDA's recommendation is to bring the highest-priority topics first and submit additional topics later 45.

Vague or unfocused questions. FDA focuses its review on the specific questions asked and may not comment on topics outside their scope even if the material is in the package 10. Questions that are broad or general, rather than clear and specific, produce correspondingly general feedback 1038.

Thin background. A Pre-Sub needs enough context for FDA to respond: a device description, proposed intended use / indications for use, prior submissions, and, where relevant, proposed protocols with rationale 38. FDA can decline to accept a Pre-Sub, or place it on hold at acceptance review or technical screening, when the request does not qualify as a Pre-Sub or the package is incomplete; the sponsor then responds with an amendment and the clock restarts 32.

Misreading how binding the feedback is. Teams over-rely on Pre-Sub feedback as a guarantee. It is not: FDA may raise new questions at the time of the full submission or when new information appears, and a favorable Pre-Sub does not assure a favorable decision later 47.

Sequencing Pre-Subs across a program

FDA expects sponsors to use Pre-Subs strategically over the life of a development program rather than as a single event. When more than one Q-Sub is anticipated for the same device, the initial Q-Sub should include an overview of the expected submissions and general timeframes, and FDA generally recommends only one Q-Sub at a time for a given device, completing feedback on one before starting the next where dependencies exist 6162. Additional information or new questions tied to an existing Q-Sub are submitted as a supplement, which at CDRH is tracked by appending "/S" and a sequential number to the original Q-Sub number (for example, Q180001/S001) 6162.

The practical takeaway

A Pre-Sub rewards discipline. The teams that get the most from it walk in with a defined intended use and pathway, three to four tightly scoped topics, no more than roughly ten specific questions, a proposed protocol with rationale where data collection is at issue, and enough background for the reviewer to answer without guessing. The teams that get the least treat it as a data audit, ask FDA to design the trial, stack a dozen loosely related questions, or ask performance-testing questions before the fundamentals are settled. The feedback is genuinely valuable, but it is advisory, time-limited in practice, and only as good as the questions it is built to answer.