Usage Examples
- The team filed a Pre-Submission to get FDA's read on the proposed predicate and the bench testing plan before finalizing the 510(k).
- A Study Risk Determination Q-Sub confirmed the clinical investigation qualified as non-significant risk.
- We raised the deficiency through a Submission Issue Request instead of burning another review cycle on a formal response.
What is Q-Submission?
Q-Submission is FDA's umbrella mechanism for a device sponsor to request feedback or a meeting rather than a marketing decision, covering Pre-Submissions, Submission Issue Requests, Study Risk Determinations, and Informational Meetings.
Q-Submissions exist because FDA and a device sponsor otherwise meet for the first time at filing, when the testing is finished and the budget is spent. Congress wrote formal meeting rights into the statute for the highest-risk cases, and CDRH generalised the idea into one request channel, so a sponsor can surface a disagreement over a predicate, an endpoint, or a test method while changing course is still cheap.
Q-Submissions cover the feedback types named in FDA's May 2025 Q-Submission Program guidance: Pre-Submissions, Submission Issue Requests, Study Risk Determinations, Informational Meetings, and other Q-Submission types. Q-Submissions do not cover classification questions, which belong in a 513(g) request with its own sixty-day statutory answer. Q-Submissions are also not applications: no Q-Submission clears, grants, or approves anything.
Q-Submissions are used in practice to settle the arguable parts of a filing before the filing exists: predicate choice, the bench and biocompatibility matrix, the clinical endpoint, the significant-risk determination. Two routes carry statutory weight instead of advice. FD&C Act 520(g)(7) obliges FDA to meet within 30 days of a written request on an investigational plan, and 513(a)(3)(D) obliges a meeting on the evidence needed for a PMA.
Not to be confused with
- 513(g) Request for Information
- a 513(g) asks FDA which class a device falls in and which requirements apply, and the statute obliges a written answer within sixty days of receipt. A Q-Submission asks for scientific or strategic feedback and has no statutory answer clock.
- Agreement Meeting under 520(g)(7)
- a 520(g)(7) agreement on an investigational plan is reduced to writing, made part of the administrative record, and cannot be changed except by the sponsor's written agreement or a documented substantial scientific issue. Pre-Submission feedback has no such protection.
- 510(k), De Novo and PMA
- those are applications that ask FDA for a marketing decision on a device. A Q-Submission asks a question and produces feedback; it never produces a clearance, a grant, or an approval.
- Breakthrough Device designation
- designation under FD&C Act 515B is a status that obliges FDA to provide interactive and timely communication across the whole development program. A Q-Submission is a single request that creates no continuing obligation on either side.
Q-Submission obligations sit mostly on the sponsor. FDA's duties attach only where the statute names them.
What you must do
- 1Send classification and applicable-requirements questions as a written 513(g) request, which FDA must answer with a written statement of the classification and the applicable requirements within sixty days of receiptFD&C Act 513(g)
- 2Include in a written meeting request a detailed description of the device, a detailed description of the proposed conditions of use, and a proposed plan including a clinical protocol, before investigating a class III or implantable deviceFD&C Act 520(g)(7)
- 3Get any agreed investigational plan reduced to writing and made part of the administrative record, since only that form is protected from unilateral change by FDAFD&C Act 520(g)(7)
- 4Request the meeting in writing before submitting a PMA when FDA needs to determine the type of valid scientific evidence necessary to demonstrate effectiveness for the proposed conditions of useFD&C Act 513(a)(3)(D)
- 5File Pre-Submissions, Submission Issue Requests, Study Risk Determinations, and Informational Meetings in the content and format set by the current Q-Submission Program guidance, issued May 2025FDA Q-Submission Program guidance (May 2025)
- 6Put any clinical protocol agreed with FDA under a Breakthrough designation in writing, because that agreement binds both FDA and the sponsor until both sides agree in writing to change itFD&C Act 515B
Common mistakes
Treating Pre-Submission feedback as an agreement
Pre-Submission feedback answers questions; it is not the statutory agreement route. Only a 520(g)(7) agreement enters the administrative record and resists unilateral change, so a program built on "FDA agreed at the Pre-Sub" can be reopened at review, after the study is enrolled and the money is gone.
Routing a classification question through a Q-Submission
Classification and applicable-requirements questions belong in a 513(g) request, where FDA owes a written answer within sixty days of receipt. Sending the same question into a Q-Sub trades a statutory clock for informal feedback and typically costs a full review cycle.
Filing before there is a concrete proposal to react to
"What testing should we do?" earns a generic answer. The statutory meeting route requires a detailed device description, the proposed conditions of use, and a proposed plan including a clinical protocol; that same specificity is what makes any Q-Submission response usable rather than a restatement of published guidance.
When This Matters
- The team filed a Pre-Submission to get FDA's read on the proposed predicate and the bench testing plan before finalizing the 510(k).
- A Study Risk Determination Q-Sub confirmed the clinical investigation qualified as non-significant risk.
- We raised the deficiency through a Submission Issue Request instead of burning another review cycle on a formal response.
Frequently Asked Questions
Only in the two statutory routes. An agreement on an investigational plan under FD&C Act 520(g)(7) is reduced to writing, entered in the administrative record, and cannot be changed except with the sponsor's written agreement or a director's documented substantial scientific issue. Ordinary Pre-Submission feedback carries no equivalent statutory protection.
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Sources & References
- 21 U.S.C. 360c - Classification of devices (FD&C Act 513), full text
- 21 U.S.C. 360j - General provisions, investigational device exemptions (FD&C Act 520), full text
- 21 U.S.C. 360e-3 - Breakthrough Devices Program (FD&C Act 515B), full text
- FDA - Agency Information Collection Activities: Q-Submission and Early Payor Feedback Request Programs and Medical Device Development Tools (Feb. 18, 2026)
