The FDA Q-Submission Program: Getting Early Feedback with a Pre-Sub

The FDA Q-Submission Program is a voluntary process that lets device sponsors ask CDRH or CBER for feedback on specific questions before they file a formal submission. The most-used type is the Pre-Submission, commonly called a Pre-Sub, which gives you FDA written feedback on the questions that matter most while your program is still flexible enough to act on the answers. Used well, a Pre-Sub is one of the highest-leverage regulatory tools available, and it is free.

What the Q-Submission Program is

The Q-Submission (Q-Sub) Program is the umbrella framework FDA uses to organize formal, tracked interactions with sponsors that fall outside a marketing application. Each interaction receives a Q number and is handled by the relevant review division. The program is described in FDA guidance titled "Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program." The Pre-Submission is the most common Q-Sub type because it is the vehicle for getting formal, written FDA input before you invest in testing or filing.

What a Pre-Sub is for

A Pre-Sub is appropriate when you want FDA feedback on specific questions and the answers will meaningfully shape your development or regulatory plan. Common uses include:

• Testing plans. Confirming whether a proposed bench, biocompatibility, or software verification approach is likely to support your future submission.
• Predicate and classification strategy. Aligning on regulatory pathway, whether a chosen predicate is appropriate, or whether a De Novo request fits.
• Clinical study design. Getting input on endpoints, sample size rationale, control groups, and acceptance criteria before enrollment.
• IDE readiness. Vetting the significant risk determination and study plan before you submit an Investigational Device Exemption.

Other Q-Sub types, briefly

The program includes several other interaction types beyond the Pre-Sub:

• Submission Issue Request (SIR). Used to discuss how to resolve deficiencies FDA raised on a specific pending submission, such as a 510(k) or PMA hold.
• Study Risk Determination. A request for FDA to determine whether a planned study is significant risk, nonsignificant risk, or exempt.
• Informational Meeting. A one-way briefing to share information with FDA (for example, a novel technology or pipeline update) when you are not asking for feedback or a decision.

The typical process and timelines

You submit a Pre-Sub package through the electronic submission system and indicate whether you want written feedback only or written feedback plus a meeting or teleconference. FDA aims to provide written feedback within roughly 70 to 75 days of receipt, and when a meeting is requested it is generally scheduled around that same window, with FDA sending preliminary written comments in advance. If you accept the written feedback as sufficient, you can proceed without a meeting. Keep in mind these are target timelines, not statutory deadlines, so build schedule margin into your plan.

Writing good questions and building the package

The quality of FDA feedback tracks directly with the quality of your questions. Frame each question so it is specific, decision-oriented, and answerable, and pair it with your own proposed approach and rationale rather than an open-ended "what should we do." Your package should give the reviewer enough context to answer efficiently:

• Device description. Intended use, indications, technology, and principle of operation.
• Regulatory background. Proposed pathway, predicate or classification analysis, and prior interactions.
• Focused questions. A numbered list, each tied to a specific decision and to your proposal for how to address it.
• Supporting detail. Draft test protocols, study synopses, or risk analyses that let FDA respond concretely.

Strategic benefits and limitations

The strategic value of a Pre-Sub is de-risking. Early alignment reduces the odds of a Refuse to Accept (RTA) hold on a 510(k), shortens deficiency cycles on a De Novo or PMA, and prevents expensive rework such as repeating a study that used the wrong endpoint. The main limitation is that Pre-Sub feedback is nonbinding: FDA can revise its position as your submission and the science evolve, though documented agreement carries real practical weight. Do not over-ask either. Bundling too many questions, or questions FDA cannot answer without the full data set, dilutes the value of the interaction. Ask the few questions that will actually change what you do.

Best practices

Time the Pre-Sub for when the answers can still steer decisions, not after protocols are locked. Limit yourself to a handful of high-value questions, state your own recommended approach for each, and keep the package concise and well organized. If you request a meeting, review FDA preliminary comments closely, prepare a focused agenda, and capture agreements in the meeting minutes you submit afterward.

How Sequence Group Can Help

Sequence Group helps device companies decide whether a Pre-Sub is the right move, then frames the questions and builds the package so FDA feedback is clear and actionable. We align your pathway and predicate strategy, draft testing and clinical plans that anticipate reviewer concerns, and prepare you for the meeting so the interaction moves your program forward. If you are planning a 510(k), De Novo, PMA, or IDE and want to reduce regulatory risk before you file, contact us to discuss a Q-Submission strategy.