FDA Q-Submission Program: How to Get Pre-Submission Feedback Before You File

The most expensive mistake in a premarket submission is not a bad study. It is a good study that answers a question FDA was not asking. The Q-Submission Program exists to stop that happening, it costs no user fee, and a large share of first-time submitters still skip it.

A Q-Submission — most often a Pre-Submission, or Pre-Sub — is a formal written request for FDA feedback on a device before you file. You send a package describing the device, your proposed regulatory pathway and your specific questions. FDA sends written feedback, usually followed by a meeting or teleconference if you asked for one. The feedback is non-binding, but it is documented, and it tells you where the review will go before you spend money finding out.

What sits inside the Q-Submission Program

The program is broader than the Pre-Sub most people mean when they use the term. It covers several request types under one framework:

Pre-Submission — feedback on planned submissions: pathway, predicate, test plan, clinical study design, software documentation. Submission Issue Request — a formal route to discuss a hold or deficiency on a submission already under review. Study Risk Determination — FDA's view on whether a planned study is significant risk, non-significant risk, or exempt, which determines whether you need an IDE. Informational Meeting — a briefing with no questions attached, used to introduce a technology or pipeline. Agreement and Determination Meetings — statutory meeting types tied to IDE clinical protocols.

Most device and software teams need the Pre-Submission and, if a clinical study is planned, the Study Risk Determination.

When to use it

The useful window is after you know what the device does and before you have locked the evidence spend.

Use a Pre-Sub when your predicate is arguable, when you believe you have no predicate and are considering a De Novo, when your intended use language sits close to a higher-risk claim, when the performance testing standard is unclear or you intend to deviate from a recognised one, when a clinical study is on the table, or when your product is software and the documentation level is contested.

Do not use a Pre-Sub to ask FDA to design your submission. Vague questions such as "what testing will you require?" produce vague answers. The teams that get value ask closed questions on a concrete plan: "We propose device X as predicate for indication Y. Does the Agency agree that the difference in Z does not raise different questions of safety and effectiveness?"

What a good package looks like

The quality of the feedback tracks the quality of the package almost exactly. A workable Pre-Sub contains:

A clear device description, including how it works and where it sits in the clinical workflow. Proposed indications for use, written in the exact language you intend to submit. Your proposed regulatory pathway and classification, with the rationale. Your predicate analysis if you are heading for a 510(k) — see our guide to predicate devices. The proposed test plan: bench, biocompatibility, electrical safety, software, cybersecurity, human factors, clinical. A short, numbered list of specific questions — typically three to five, never fifteen. Your position on each question, so FDA is reacting to a proposal rather than authoring one.

That last item is the single biggest differentiator. Reviewers respond far more usefully to "here is our plan and our reasoning, do you agree" than to an open request for direction.

The timeline, and how to plan around it

FDA's stated goal for Pre-Submissions is to provide written feedback within 70 days of receipt, or within five days of a scheduled meeting, whichever comes first. Meetings are typically scheduled within 60 to 75 days of the request. In practice, plan for roughly three months from filing the Q-Sub to having usable feedback in hand.

That is not dead time if you sequence it properly. Run design verification planning, quality system work and reimbursement strategy in parallel rather than pausing everything to wait. What you should not do is start an expensive clinical study during the wait, since study design is usually one of the things you asked about.

There is no user fee for a Q-Submission, which makes the real cost your team's preparation time plus any consultant support — a small fraction of the 510(k) or PMA fees you are trying to protect.

Running the meeting

If you request a meeting, FDA sends written feedback in advance. Read it as the primary output; the meeting is for clarification, not for reopening the answers.

Send an agenda and a short list of clarifying points ahead of time. Keep the attendee list tight and make sure the person who can speak to each technical area is on the call. Take detailed minutes, send them to FDA within 15 days, and treat the combination of FDA's written feedback and your accepted minutes as the record you will cite in the eventual submission.

Feedback is non-binding, and FDA can change position if the device or the science changes. But a submission that visibly follows documented Pre-Sub feedback moves through review faster, and a submission that quietly ignores it invites the deficiency letter you were trying to avoid.

Three things to do now

Write your questions before you write the package. If you cannot state three specific decisions the feedback would change, you are not ready to file a Pre-Sub.

Take a position on every question. Feedback on a proposal is worth more than feedback on a blank page.

Sequence it against your funding milestones. Add roughly 90 days to your plan and place the Pre-Sub before the evidence spend, not after it.

For the broader pathway picture, see the FDA regulatory pathways guide and the pathway selection article. If you are running EU work in parallel, the EU MDR and UKCA guide covers where the evidence expectations diverge. MedTech Compass maps regulatory and reimbursement conditions across 25+ markets, and DevicePath gives you an open model for early classification triage.

Sources

1. FDA — Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program (guidance): https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-medical-device-submissions-q-submission-program 2. FDA — Investigational Device Exemption (IDE): https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-advice-investigational-device-exemption-ide 3. FDA — Premarket Notification 510(k): https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k 4. FDA — De Novo Classification Request: https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/de-novo-classification-request 5. FDA — How to Study and Market Your Device: https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/how-study-and-market-your-device

This article summarises public FDA guidance and is not legal or regulatory advice.