Leverage FDA Pre-Submission (Q-Sub) meetings to get early feedback on your medical device. Clarify testing, validate your regulatory strategy, and address potential issues before submission to streamline review, reduce delays, and accelerate approval.
The FDA’s Q-Submission (Q-Sub) program – especially the Pre-Submission meeting – is one of the most valuable tools for medical device companies to get FDA feedback early in the development process. A well-prepared Pre-Sub meeting can validate your regulatory strategy, clarify testing requirements, and head off potential deficiencies in your later submission. This section guides you through effectively preparing for a Q-Submission meeting, covering the planning, submission, and execution of a Pre-Sub so you can maximize the benefit of FDA’s insights.
A Pre-Submission (often called “Pre-Sub”) meeting is a formal request for feedback from the FDA on specific questions or aspects of your device before you submit an IDE, 510(k), De Novo, or PMA application. Importantly, participating in Pre-Subs is voluntary – they are not required by regulations – and FDA’s advice is non-binding. However, FDA strongly encourages sponsors to use Pre-Subs whenever guidance on study design, regulatory pathway, or testing strategy is needed. As the FDA’s 2025 guidance states, the Q-Sub process “allows device sponsors to engage with FDA outside of formal marketing submissions” and has expanded over time to facilitate early discussions throughout device development.
The primary goal of a Pre-Sub meeting is to ask the FDA specific questions that will guide your product development or submission preparations. In return, you receive written and/or meeting feedback that, while not an official decision, can greatly inform your next steps. This can save enormous time and resources – sponsors often adjust study protocols or perform additional tests based on FDA feedback, rather than discovering the need for those changes during the review of the final submission. In fact, using the Pre-Sub process “can save time and conserve resources by… potentially avoiding review deficiencies.” Many companies credit Pre-Sub meetings with helping them get their 510(k) or PMA approved on the first pass, since obvious questions were resolved in advance.
Success hinges on preparation. A Pre-Submission request to FDA is typically a well-structured package that includes:
Ensure the Q-Sub submission is complete and sent via the proper format (currently an eCopy or the newer eSTAR template). Incomplete submissions will not be accepted for review, so use FDA’s checklist to verify all required elements are present. Once submitted, the FDA will perform a quick acceptance review and then begin evaluating your questions.
After submission, what should you expect? Under the Q-Submission program guidelines, FDA intends to provide written feedback to your Pre-Sub questions within 70 days of receiving the request, or at least 5 days before a scheduled meeting – whichever comes first. In practice, this means if you have a meeting set for Day 75, you will get preliminary written responses around Day 70. These preliminary responses are extremely useful: they allow you to prepare more effectively for the meeting by highlighting areas of agreement or remaining concern. If some answers are fully resolved in writing, you can plan to focus the meeting time on the unanswered or unclear points.
FDA usually accommodates one of the sponsor’s proposed meeting dates. Meetings are generally one hour by teleconference (in-person meetings are less common now, but still possible). During the meeting, FDA typically has their review team present (often the lead reviewer, subject matter experts like engineers or medical officers, and possibly branch or division management). The meeting is your chance to clarify FDA’s written feedback, ask follow-up questions, and ensure you understand any advice given. It is not a venue to “pitch” your product or have general discussions outside the scope of your submitted questions. Staying on topic is important due to time limits.
Immediately after the Pre-Sub meeting, it’s wise to have an internal debrief. Compare notes (the FDA will not typically provide official minutes or a transcript). You are required to send meeting minutes to the FDA within 15 days for Q-Sub meetings. This written record should summarize the discussion and any conclusions or action items. FDA will review your minutes and may edit or concur to ensure an accurate record. These finalized minutes become part of the formal file.
Crucially, leverage the FDA’s feedback in your next steps. FDA often provides advice like adjusting a study design, performing an extra test, or clarifying a predicate rationale. Use this input to modify your plans before you make your formal submission. When you eventually submit your 510(k) or other application, reference the Pre-Submission feedback and describe how you addressed it. This shows the FDA that you took their input seriously and helps the reviewers see that their previous concerns have been resolved.
Finally, if new questions arise or significant changes occur after the Pre-Sub, you can always seek additional feedback – for example, by submitting a Pre-Sub supplement (a follow-up Q-Sub on the same topic). FDA encourages ongoing dialog, especially for complex projects. The overarching principle is to avoid going silent: it’s far better to ask FDA and get clarity than to guess and be wrong.
An effective Pre-Submission meeting can be a game-changer in medical device development. By carefully preparing your Q-Sub request, asking the right questions, and actively engaging during the meeting, you gain invaluable insight into FDA’s expectations. This upfront investment pays off with a smoother submission and review – often preventing costly delays or rework. Our regulatory experts have helped numerous clients craft successful Pre-Sub strategies, from formulating targeted questions to leading the meeting dialog. With the right preparation and guidance, your FDA Q-Submission meeting can set the course for a swift and successful device approval.
