An FDA Pre-Sub meeting is a voluntary Q-Submission interaction that gives medical device sponsors non-binding written feedback before a marketing submission. Submitting a well-structured package with focused questions can save 6 to 18 months of development time, and the FDA targets a written response within 75 days of receipt. That window's value depends almost entirely on how the request package is prepared. Sponsors who treat the Pre-Sub as a formality, submitting vague questions or incomplete context, get hedged answers that move nothing forward. This guide covers how to prepare a focused package and write questions that produce specific, actionable answers.
What Is an FDA Pre-Sub Meeting and Why Does It Matter?
The Pre-Submission program is a formal channel through which medical device and combination product sponsors can request written feedback from the FDA before filing a 510(k), PMA, De Novo, or IDE application. The agency reviews the package, consults internally, and issues a written response. Sponsors may also request a meeting to discuss that response directly with the review team.
The program is voluntary. No regulation requires a sponsor to file a Pre-Sub before submitting a marketing application. The practical case for using it is strong, though: early clarity on testing requirements, regulatory classification, and clinical study design can prevent sponsors from generating 6 to 18 months of data the agency will not accept.
The Q-Submission program covers several distinct interaction types, and choosing the right one matters.
Pre-Submission (Pre-Sub) is the most commonly used format. It allows sponsors to ask broad questions about regulatory strategy, bench testing protocols, clinical study design, and software documentation requirements. The FDA provides formal written feedback and, when requested, schedules a meeting with the relevant review division. Feedback is advisory; it is not legally binding on the agency.
Study Risk Determination (SRD) is a narrower format with a faster turnaround. Sponsors use it to ask a single focused question: does the FDA consider the planned clinical study to be significant risk, nonsignificant risk, or exempt? That determination controls whether the sponsor needs a full Investigational Device Exemption (IDE) application or only Institutional Review Board (IRB) oversight. Because the SRD's scope is limited, the FDA can process it more quickly than a full Pre-Sub.
Other Q-Sub types include the Submission Issue Request (SIR), used to resolve a specific deficiency in a pending submission, and informational meetings, which allow sponsors to brief the agency on a technology without asking formal questions.
Most early-stage sponsors preparing for a first-in-human (FIH) study or an IDE application will use the Pre-Sub as their primary tool. The SRD is a useful complement when the risk classification of a planned study is genuinely uncertain. Knowing which format fits your situation before drafting a single question saves time and shapes the entire preparation process.
The FDA's pre-submission guidance, published and updated by the Center for Devices and Radiological Health (CDRH), describes the program's procedures, content expectations, and response commitments in detail. That document is the authoritative reference; this guide translates its requirements into a practical preparation sequence.
How Does the FDA Pre-Sub Meeting Timeline Work?
The FDA targets scheduling a Pre-Sub meeting within 75 days of receipt and typically confirms the meeting date within 15 days of receiving the request. That 75-day window is a target, not a contractual guarantee. Review division workloads, submission volume, and the complexity of the questions submitted can all affect the actual timeline.
For planning purposes, treat 75 days as the expected minimum from submission to meeting. Add time for internal preparation, package assembly, and any back-and-forth with the FDA's document receipt staff, and the realistic horizon from decision to meeting is closer to three to four months.
The sequence runs as follows. The sponsor submits the Pre-Sub package through the FDA Q-Submission portal. The agency acknowledges receipt and assigns a tracking number. Within approximately 15 days of receipt, the review division confirms a meeting date within the 75-day target window, which is the same target cited above. The FDA then prepares its written response, which the sponsor receives before the meeting so there is time to review it and prepare follow-up discussion points. The meeting itself, which can be held online, by teleconference, or in person, typically runs 60 to 90 minutes.
For an online FDA Pre-Sub meeting, the FDA uses its standard teleconference infrastructure. Sponsors do not need to travel to Silver Spring. The agency has conducted the majority of Pre-Sub meetings virtually since 2020, and that format is now standard practice.
If the FDA does not hold a meeting within the target window, sponsors can follow up through the review division's project manager. The agency's written response still carries value even without a live meeting, and sponsors should plan to act on the written feedback regardless of whether a meeting occurs.
One practical implication: if your IDE application or 510(k) submission has a hard internal deadline, work backward from that date. A Pre-Sub submitted too late to receive a response before your submission window closes provides limited benefit. Build the Pre-Sub into your development calendar at least five to six months before your planned marketing or IDE submission date.
Step-by-Step: How to Prepare Your FDA Pre-Sub Package
A complete Pre-Sub package gives the FDA enough context to answer your questions accurately and enough specificity to make those answers actionable. The steps below follow the order in which sponsors should build the package, from device description through final formatting.
-
Describe the device's mechanism of action and current development status. Start with a concise summary of what the device does, how it works, and where it stands in development. Include the intended use, the target patient population, and the current prototype or design iteration. This section orients the review team before they reach your questions [S5].
-
Detail the regulatory history and proposed classification pathway. State the device's proposed product code, predicate device (if applicable), and the regulatory pathway you intend to pursue: 510(k), De Novo, PMA, or IDE. If the device has any prior FDA interaction history, summarize it here [S4].
-
Draft a numbered list of specific questions focused on no more than four major topics. Each question should be answerable on its own, without requiring the reviewer to infer context from elsewhere in the package. Group related questions under a topic heading. Limit the total question count to the range the FDA finds workable, and keep each question to a single issue. Compound questions ("Is our bench testing adequate, and if not, what additional testing would you recommend?") are harder for reviewers to answer cleanly and often produce partial responses [S3].
-
Include draft protocols and bench testing data to provide context. If you are asking about the adequacy of a test protocol, include the draft protocol. If you are asking whether your bench data supports a particular claim, include the data. The FDA cannot evaluate what it cannot see. Attaching supporting data does not commit you to that protocol; it gives the agency something concrete to respond to rather than answering in hypotheticals [S2].
-
Propose at least three potential meeting dates 60 to 75 days in the future. This step is administrative but affects scheduling. Offering a range of dates in the correct window prevents delays caused by the FDA having to request alternatives. Place the proposed dates in the cover letter or the meeting request section of the package, clearly labeled [S1].
-
Package the submission using the eCopy format or the eSTAR electronic template. The FDA accepts Pre-Sub packages in eCopy format, which follows CDRH's electronic submission guidance. Some sponsors also use the eSTAR electronic template, an interactive tool that guides users through the data and documentation fields required for FDA submissions and helps ensure the package meets acceptance criteria. The eSTAR template is appropriate for Pre-Submissions and marketing submissions such as 510(k)s, but it is not required for all Pre-Sub packages. Confirm the current format requirements in the FDA's pre-submission guidance before finalizing the package. Submit through the FDA Q-Submission portal, which is the agency's standard electronic gateway for Q-Sub interactions [S6].
A package built in this sequence gives the review team a clear picture of the device, a defined regulatory context, and a focused set of questions they can answer with specificity. The goal is not to impress the FDA with documentation volume. It is to make their job easy enough that the written response addresses exactly what you need to know.
How Do You Write FDA Pre-Sub Meeting Questions That Get Useful Answers?
The quality of the FDA's written response depends directly on the quality of the questions you submit. Vague or overly broad questions produce hedged answers that leave sponsors no better informed than before the submission.
The FDA suggests limiting a Pre-Sub request to no more than four major topics and a maximum of 7 to 10 questions total. That constraint is not arbitrary. Reviewers across multiple FDA divisions coordinate to prepare a single written response, and a package with 20 questions spread across six topics forces that coordination to break down. The result is a response that addresses some questions thoroughly and others only in passing. Staying within the suggested range keeps the review team focused and increases the likelihood that every question receives a substantive answer.
Topic scoping comes before question drafting. Before writing a single question, identify the four decisions in your development program that carry the most regulatory risk. Common candidates include: the adequacy of your bench testing protocol for a specific performance claim, the clinical study design and patient population for an IDE application, the predicate device strategy for a 510(k), and the software documentation requirements for a device with a software component. Once those four topics are fixed, every question should map to one of them. Questions that fall outside the four topics get cut or saved for a subsequent Pre-Sub.
Phrasing determines whether a question is answerable. The FDA cannot respond usefully to a question that asks for a general opinion. Compare these two versions:
Unproductive: "Does the FDA have any concerns with our device?"
Productive: "Does the proposed bench testing protocol in Attachment B, specifically the fatigue testing methodology described in Section 3.2, meet the performance testing requirements for a Class II cardiovascular device under product code DQO?"
The first version gives the reviewer nothing to anchor a response to. The second names a specific document, a specific section, a specific product code, and a specific regulatory standard. The reviewer can either confirm adequacy, identify gaps, or recommend an alternative standard. All three outcomes are actionable.
A few additional practices improve question quality. First, write each question so it stands alone. The reviewer should not need to read three paragraphs of background text to understand what is being asked. Second, avoid compound questions. If you need answers to two related issues, write two separate questions. Third, where your question involves a protocol or dataset, reference the attachment by name and section number in the question itself. That cross-reference prevents the reviewer from answering in hypotheticals.
Questions about clinical study design benefit from one additional element: state the study population, the primary endpoint, and the follow-up duration in the question body, not just in the attached protocol. Reviewers who can see the key parameters without leaving the question page tend to give more precise answers about what the FDA will and will not accept.
One category of question to avoid entirely is the approval-seeking question. Asking "Will the FDA clear our device if we complete this testing?" is not something the Pre-Sub program can answer. The program provides non-binding feedback on strategy and methodology. It does not pre-authorize a submission outcome. Framing questions around what the agency will accept, rather than what it will guarantee, keeps the interaction within the program's actual scope.
What Should You Do Before, During, and After the FDA Pre-Sub Meeting?
The written response the FDA sends before the meeting is the core deliverable of the Pre-Sub process. The meeting itself is an opportunity to clarify that response, not a substitute for it.
**Before the meeting, ** read the written response carefully and identify any answer that is conditional, incomplete, or uses language that could be read more than one way. Prepare a short list of clarifying questions for each ambiguous point. Share the response with your regulatory counsel, your principal investigator if a clinical study is involved, and any engineering leads whose work is directly addressed. The meeting runs 60 to 90 minutes, and that time goes quickly. Arriving without a prepared agenda wastes it.
Also confirm the logistics. An online FDA Pre-Sub meeting uses the agency's standard teleconference platform. The FDA project manager assigned to your submission will send connection details in advance. Test the connection before the meeting day. Designate one person on your team as the primary speaker for each topic area so the discussion does not stall on internal coordination during the call.
**During the meeting, ** take verbatim notes or record the session with the FDA's permission. The written response is the official record, but the meeting discussion often adds context that the written document does not capture. Note any point where an FDA reviewer qualifies or expands on the written answer. If the FDA raises a concern that was not addressed in your questions, ask whether it can be addressed in a follow-up Q-Sub rather than trying to resolve it on the spot.
Do not treat the meeting as a negotiation. The FDA's feedback is non-binding, and the agency is not in a position to commit to a clearance or approval outcome during a Pre-Sub discussion. The goal is clarity, not agreement.
**After the meeting, ** update your development plan to reflect the FDA's written answers and any clarifications from the discussion. Document which questions received clear answers, which received conditional answers, and which remain open. Open items should drive the agenda for any follow-up Pre-Sub or SRD. If the FDA's response contradicts an assumption that was built into your testing plan or clinical protocol, revise those documents before proceeding. Acting on feedback promptly is what keeps the development program on track and prevents the rework that stalls submissions.
Pre-Sub Question and Package Checklist
Use this checklist to audit your Pre-Sub package before submission. A package that clears every item gives the FDA the context it needs to provide specific, actionable written feedback.
Device description and development status
- Concise description of the device's mechanism of action and intended use
- Current development stage (concept, prototype, bench-tested, etc.)
- Target patient population and clinical indication
- Investigational device disclaimer included where applicable
Regulatory history and pathway
- Proposed product code and device classification
- Intended regulatory pathway: 510(k), De Novo, PMA, or IDE
- Summary of any prior FDA interactions, submissions, or correspondence
- Predicate device identified (for 510(k) submissions)
Questions
- No more than four major topic areas, with a total of 7 to 10 questions across them
- Total question count within the 7 to 10 question range
- Each question is numbered and maps to a single topic
- Each question is self-contained and does not require surrounding context to interpret
- No compound questions (one issue per question)
- Supporting attachments referenced by name and section number within each relevant question
- No approval-seeking questions that fall outside the Pre-Sub program's scope
Supporting documentation
- Draft bench testing protocols attached for any question about testing adequacy
- Relevant bench data included where the question concerns data sufficiency
- Draft clinical protocol attached if questions address study design or patient population
Meeting request and logistics
- At least three proposed meeting dates, each 60 to 75 days from the planned submission date
- Preferred meeting format stated (online teleconference is standard)
- Primary contact name and information included
Package format
- Submission formatted as an eCopy or using the eSTAR electronic template per current CDRH guidance
- Cover letter includes the Q-Sub request type (Pre-Sub, SRD, or other) and a brief statement of the program's purpose
- Package submitted through the FDA Q-Submission portal
When Does It Make Sense to Use a CRO for FDA Pre-Sub and IDE Pathway Alignment?
Sponsors with in-house regulatory affairs staff experienced in CDRH submissions can often manage Pre-Sub preparation internally. The process is documented, the format is defined, and the FDA's pre-submission guidance spells out what the agency expects. If your team has prepared Pre-Subs before and understands how to scope questions for a specific review division, the internal route is reasonable.
The case for outside support is stronger when the device is novel, the regulatory pathway is genuinely uncertain, or the sponsor is simultaneously managing IDE pathway planning alongside the Pre-Sub. A first-in-human study adds clinical protocol development, study risk determination, and site selection to the workload at the same time the Pre-Sub package is being built. Running those workstreams in parallel without dedicated regulatory and clinical operations experience is where programs lose months, not days.
bioaccess® drafts Pre-Sub questions aligned with the IDE strategy and structures the supporting documentation to produce answers the development team can act on. That coordination matters most when the Pre-Sub questions directly affect the clinical protocol, which is common in FIH programs where bench data and early clinical design are developed together.
bioaccess® is a Miami-headquartered CRO serving MedTech, biopharma, and radiopharma sponsors. Its FIH-12™ program covers FDA Pre-Sub and IDE/IND pathway alignment as part of a nine-workstream, 12-month engagement that runs from initial regulatory strategy through delivery of a submission-ready clinical evidence package. For sponsors who need Pre-Sub preparation integrated with protocol development and site activation, that end-to-end structure removes the coordination burden from an internal team that may not yet have the bandwidth to carry it.
If your team does not have the regulatory depth or bandwidth to prepare a focused Pre-Sub package while advancing the rest of the development program, contact bioaccess® to discuss your pathway and what a structured Pre-Sub and IDE engagement would cover.
Prices and plan limits verified as of October 2026.
FAQs
What is the difference between a Pre-Sub and a Q-Submission?
A Q-Submission is the umbrella program the FDA uses for all pre-submission interactions, including Pre-Subs, Study Risk Determinations, Submission Issue Requests, and informational meetings. A Pre-Submission, or Pre-Sub, is one specific type of Q-Sub. When sponsors say they are filing a Pre-Sub, they mean a Q-Submission request for formal written feedback and, optionally, a meeting with the relevant FDA review division before filing a marketing or IDE application.
Is a Pre-Sub meeting required before submitting a 510(k) or PMA?
No. The Pre-Submission program is voluntary. No regulation requires a sponsor to file a Pre-Sub before submitting a 510(k), PMA, De Novo, or IDE application. Sponsors choose to use it because early written feedback on testing requirements, regulatory classification, and clinical study design can prevent costly rework later in the development program.
Can a Pre-Sub meeting be held virtually or online?
Yes. The FDA has conducted the majority of Pre-Sub meetings by teleconference since 2020, and virtual meetings are now standard practice. Sponsors do not need to travel to the FDA's Silver Spring campus. The agency's project manager assigned to the submission sends connection details in advance. Sponsors should confirm the format preference in the meeting request section of the Pre-Sub package.
What happens if the FDA does not respond within 75 days?
The 75-day window is a target, not a contractual guarantee. If the FDA has not confirmed a meeting date or provided a written response within that window, the sponsor can follow up through the review division's assigned project manager. The written response remains the primary deliverable even if a meeting is delayed, and sponsors should plan to act on it regardless of whether the live meeting occurs on schedule.
How many questions can you ask in a single Pre-Sub request?
Keeping the question list to four major topics and a focused set of questions per topic is the single most effective way to get complete written answers. Questions that fall outside the four core topics are better saved for a follow-up Pre-Sub rather than added to the current package.
Conclusion
An FDA Pre-Sub meeting gives sponsors non-binding written feedback that can redirect a development program before months of work are committed to a path the agency will not accept. The 75-day response target is a planning asset, but only if the package that triggers it is specific and focused enough to produce answers the team can act on.
Start by identifying the four regulatory decisions in your program that carry the most risk, then build every question around those topics. Assemble the supporting documentation before you draft the questions, not after. If your team is also managing IDE pathway planning or clinical protocol development at the same time, consider whether outside regulatory and clinical operations support would protect more development time than it costs.
Leave a Reply