A good FDA Q-Sub strategy comes down to four decisions. Which interaction type fits your question. When in development you file. How tightly you frame your questions. How you document the feedback for your later submission. Get those right and a Q-Sub gives you written FDA input before you spend months on the wrong pathway, the wrong testing plan or the wrong evidence.
We work with healthcare SaaS and digital health companies, and the pattern is consistent. Founders treat the Pre-Sub as a formality or as a pre-review of their application. It is neither. It is a structured way to ask FDA specific questions and get an answer you can build on.
TL;DR
- The Q-Submission program is FDA's voluntary channel for feedback and meetings on device submissions. FDA's guidance covers four interaction types, and the Pre-Submission is the one most startups need.
- Target FDA's 70-day written feedback window when you plan your timeline, and file one Q-Sub at a time for a given device.
- Ask a small number of numbered, specific, answerable questions. Do not ask FDA to design your study or classify your product.
- Feedback is non-binding but durable, as long as your final submission matches what you described. Reference the Q-Sub in your cover letter.
- For software, settle early whether your product is a regulated device at all. That decision shapes every question you ask.
Table of Contents
- What a Q-Sub is and who can use it
- Choosing the right Q-Sub type
- What a Pre-Sub is not for
- When to file in your development timeline
- Software, SaMD and the device question
- How to build the request
- Running the meeting
- Using the feedback
- Common mistakes we see
- Our perspective
- Work with The StartUp MD
- FAQ
- Sources
What a Q-Sub is and who can use it
The Q-Submission program gives sponsors a way to request FDA interaction tied to device submissions. According to the FDA guidance issued in May 2025, that includes written feedback or a meeting related to IDE applications, PMAs, HDEs, De Novo requests, 510(k)s, CLIA Waiver by Applications, Dual submissions, Accessory Classification Requests, and certain INDs and BLAs submitted to CBER.
Two features matter for a startup budget. The program is voluntary, and FDA does not charge a user fee for it. Feedback can come as a written response, a teleconference or an in-person meeting. FDA also keeps the existence of a Q-Sub confidential, within the limits of the FD&C Act, its disclosure regulations and FOIA, per the 2025 guidance.
That confidentiality helps when you are in the middle of a financing. You can ask hard questions about your pathway without publishing your plans.
Choosing the right Q-Sub type
The 2025 final guidance describes four interaction types: Pre-Submissions, Submission Issue Requests, Study Risk Determinations and Informational Meetings. Most early-stage teams will use the first and, occasionally, the last.
| Type | What it is for | Typical use |
|---|---|---|
| Pre-Submission | Formal written feedback on specific questions, with a meeting if you choose | Pathway, testing, clinical evidence and software documentation questions before you file |
| Submission Issue Request | Feedback after FDA has placed an application on hold | Resolving a hold letter on an active submission |
| Study Risk Determination | FDA's determination on the risk of a planned study | Deciding whether a study needs an IDE |
| Informational Meeting | Sharing information with FDA without expecting feedback | Introducing a new technology or company roadmap |
Pre-Submission: the workhorse
A Pre-Sub is a formal written request for FDA feedback. It is appropriate when FDA's answers to specific questions would guide development or submission preparation. It is not a pre-review of your intended submission or of data you plan to include.
That last point trips up a lot of teams. If you send a near-final package and ask "is this acceptable?", you are asking for a review FDA does not provide in this channel. Ask instead about the decision points that shape the package.
Informational Meeting: useful, but know what you get
An Informational Meeting lets you share information with FDA without expecting feedback. FDA staff generally listen and are not prepared to give feedback. It can make sense for a novel AI-enabled product where reviewers would benefit from background before a formal question arrives. If you need an answer you can plan around, file a Pre-Sub.
Submission Issue Request and Study Risk Determination
A Submission Issue Request applies after an FDA hold letter. If you send it more than 60 days after the letter, FDA aims to respond within 70 days as resources permit. Study Risk Determinations come back as a formal letter, with a 90-day timeframe listed in FDA's table. Neither is a first step for a company still choosing its pathway.
What a Pre-Sub is not for
FDA's own program materials say a Pre-Sub is not meant for:
- General information requests or questions
- Asking FDA to design your study protocol or clinical trial
- Substituting for your own research and analysis
- Questions a reviewer could readily answer
- Interactive review of an active submission
- Appeals of a decision on a premarket submission
- Jurisdictional designation or device classification requests
If your core uncertainty is whether your software is a device, resolve that first through your own regulatory analysis. We cover the boundary cases in our piece on how healthtech teams avoid a 510(k) for MDDS.
When to file in your development timeline
The best moment is after you have a defined intended use and a draft pathway, but before you lock design, testing or clinical evidence. FDA's 2025 guidance stresses early interaction to improve submission quality and streamline review. Used well, a Pre-Sub can save time and resources by surfacing review deficiencies in advance.
Plan around the clock. Under FDA's timeline table, written feedback for a Pre-Sub is due within 70 days of the review clock start. If you request a meeting, written feedback arrives at least 5 days before it, and meeting dates between 70 and 75 days after receipt are most likely to be feasible. Add your own prep time and a few weeks to digest and act on the answers. A realistic planning block is one quarter or more.
Rules of thumb for sequencing
- File one Q-Sub at a time per device. FDA recommends a single Q-Sub at a time because reviewing several on the same device is difficult. If you expect more than one, put an overview of expected submissions and general time frames in the first.
- Do not file before your intended use is stable. FDA can modify earlier feedback if you significantly change the intended use, technology or labeling.
- Remember there is no obligation to follow with a premarket submission. A Q-Sub also cannot be withdrawn once feedback is provided and the file is closed, so file when you are ready to hear the answer.
- Line it up with fundraising. Investors value documented regulatory direction. A Pre-Sub response is often a milestone worth scheduling ahead of a diligence process.
Software, SaMD and the device question
Healthcare SaaS is where this gets harder. Many products sit near the line between clinical software that is a device and administrative or workflow software that is not. A Q-Sub strategy only works if you have settled which side you are on, or if you are asking a question that depends on it and say so.
For products that are devices, the common Pre-Sub topics are:
- Pathway. 510(k) with a predicate, or De Novo for a novel low-to-moderate risk device. Our guide to De Novo versus 510(k) strategy for SaMD founders walks through that decision.
- Software documentation. What level of documentation FDA expects for your software. Our list of common SaMD guidance submission gaps shows where startups fall short.
- Clinical decision support. If your product informs diagnosis or treatment, the evidence expectations matter. See the documents FDA reviewers want for clinical decision support.
- Cybersecurity and SBOM. These are now part of the conversation for connected software. Our notes on required cybersecurity deliverables and SBOM-driven regulatory strategy explain what to prepare.
- Planned changes. For AI and adaptive software, a predetermined change control plan is a natural Pre-Sub subject.
- Quality system. FDA encourages innovators to ask general quality system questions, including manufacturing questions, during a Pre-Sub meeting. The quality system regulation, 21 CFR Part 820, applies to finished device manufacturers. Our checklist on QMSR and 21 CFR 820 covers the first steps.
How to build the request
A strong Pre-Sub package reads as if a busy reviewer wrote the table of contents. Common guidance from regulatory practitioners is that a complete package includes a cover letter, device description, pathway justification and numbered questions, with preliminary data where you have it. The cover letter should state the feedback format you prefer, written only or written plus meeting.
Write questions FDA can answer
The weakest Pre-Subs ask open questions. The strongest ask closed ones that include your proposal.
| Weak question | Stronger version |
|---|---|
| What testing do we need for our algorithm? | Does FDA agree that the proposed retrospective validation dataset, described in Section 4, is adequate to support performance claims for the stated intended use? |
| Is our software a device? | Given the intended use in Section 2, does FDA agree that a De Novo request is the appropriate pathway? |
| Can you review our clinical study? | Does FDA agree that the primary endpoint and comparator described in Section 5 are appropriate for the intended use? |
Note that the second row assumes you have already done your own device analysis. Classification and jurisdiction requests are outside what a Pre-Sub is for.
Keep it focused
Five to eight well-built questions generally beat twenty. Each should be numbered, contextualized with the relevant section of your package, and actionable: a yes, no or "modify as follows" from FDA should change what you do next. Put your most important questions first.
Running the meeting
If you choose a meeting, treat the written feedback as the agenda. Because FDA sends it in advance, the meeting is where you clarify and resolve open items, not where you present your product from scratch.
A practitioner view is that a typical Pre-Sub meeting runs about 60 minutes, with a few minutes of background, most of the time on questions, and a short wrap-up. Open with your most critical items so they get covered if time runs out. Under the current process, the meeting discussion is summarized in minutes drafted by the submitter and submitted to FDA for review, so assign a note-taker and plan to draft those quickly.
Security questions deserve their slot on the agenda if your product is connected. Our partners' overview of medical device cybersecurity guidelines is a helpful way to organize which technical items to prioritize before you walk into the room. For our own checklists, see the seven-item FDA cybersecurity checklist.
Using the feedback
FDA describes its feedback as its best advice based on the information in the Pre-Sub and what was known at that time. It is non-binding and does not guarantee clearance or approval. Still, FDA intends not to change that feedback if your later marketing submission is consistent with what you described and no new issues materially affect safety or effectiveness.
FDA may modify earlier feedback when new scientific findings emerge, when there is a new public health concern, or when you make significant changes to the intended use, device technology or labeling. Practically, that means:
- Freeze what you told FDA. Keep a version-controlled copy of the exact package you submitted.
- Track deviations. If engineering, labeling or intended use drifts, decide whether the change warrants a new Q-Sub.
- Map each answer to an action. Turn every response into a task: protocol update, test report, documentation change.
- Reference the Q-Sub in your final submission. Identify it in the cover letter and include a section explaining how previous feedback was addressed.
- Plan for post-market. Your evidence plan continues after clearance. See our overview of post-market clinical surveillance.
Common mistakes we see
- Filing too early. The intended use is still shifting, so the answers go stale.
- Filing too late. Design is frozen, and any disagreement is expensive.
- Asking FDA to do the homework. Questions without your proposal invite generic answers.
- Overloading the request. Long question lists dilute the ones that matter.
- Ignoring the clinical story. Reviewers read intended use, workflow and patient risk together. A technical package that cannot explain the clinical context draws more questions.
- Losing the thread. The Q-Sub is never mentioned in the final submission.
Our perspective
Most healthtech founders come to a Q-Sub with a technical story and a regulatory deadline. What gets missed is the clinical story. FDA reviewers ask what the product does to a clinician's decision, which patient it touches and what happens when it is wrong.
That is why we think a Q-Sub strategy should start with clinical strategy, not paperwork. When intended use, workflow and risk are written in the language of real patient care, the questions get sharper and the answers get more useful.
It is also why we build engagements around direct access to a physician executive. A fractional Chief Medical Officer who has worked in both care delivery and startups can pressure-test your intended use, help shape your questions and keep the clinical argument consistent from Pre-Sub to launch to investor update.
If something about your pathway feels misaligned, I would welcome a conversation before you file.
Paul Bergeron MD, MBA
Work with The StartUp MD
The StartUp MD is a healthcare advisory firm led by Paul Bergeron, MD, MBA. We provide Fractional Chief Medical Officer support and advisory services for healthcare SaaS and healthtech startups, including clinical strategy, product evaluation, regulatory guidance and investor support. If you are preparing for FDA interaction, we can help you frame the clinical rationale and the questions that go with it.
See our Fractional CMO and advisory services or reach us through The StartUp MD.
FAQ
Does a Q-Sub cost anything?
No. FDA's program materials state that the Q-Sub program is voluntary and carries no user fees. Your costs are internal time and any outside regulatory or clinical support you use to prepare.
How long does FDA take to respond to a Pre-Sub?
FDA's timeline calls for written feedback within 70 days of the review clock start, or at least 5 days before a scheduled meeting. Meetings are most often feasible around days 70 to 75, per the 2025 guidance. Treat these as targets, and confirm current practice with your review division.
Is FDA's Pre-Sub feedback binding?
No. It is non-binding and does not guarantee clearance. FDA intends not to change its feedback if your later submission is consistent with the Pre-Sub and no new issues materially affect safety or effectiveness, as the guidance explains.
Can I send more than one Q-Sub at once?
FDA recommends only one at a time for a given device. If you plan several, include an overview of the expected submissions and time frames in the first one.
Do I need a Q-Sub before every submission?
No. The program is voluntary, and a Q-Sub does not require a follow-on premarket submission. It is most valuable when you face real uncertainty about pathway, testing or evidence.
Sources
- Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program (FDA)
- The Q-Submission Program guidance, May 2025 (FDA)
- Q-Submission guidance, final 2025 (HHS)
- The Pre-Submission Program and Meetings with FDA Staff (FDA)
- Activities to Support Medical Device Innovators (FDA)
- FDA Issues Two Guidances For the Device Q-Sub Process (King & Spalding)
- FDA Pre-Submission Guide (MedDeviceGuide)