FDA Q-Submission Program: Pre-Subs and Other Device Meetings

The FDA Q-Submission Program is the mechanism device sponsors use to get the agency’s feedback before committing to a final study design, predicate choice, or submission strategy. It is not one meeting type — it is a family of request formats, each suited to a different stage and a different question, and choosing the wrong one wastes the sponsor’s own clock as much as FDA’s. This guide covers the request types that matter most in practice: the Pre-Submission (Pre-Sub), the Study Risk Determination request, and the Informational Meeting, plus how to write questions FDA will actually answer, what its feedback timeline looks like, and how much of that feedback a sponsor can actually rely on later.

What the Q-Submission program is (and is not)

“Q-Submission” (Q-Sub) is FDA’s Center for Devices and Radiological Health (CDRH) umbrella term for a family of pre-market and mid-review communication requests, covered by the guidance Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. Every Q-Sub gets a tracking number in the format Q##XXXX and is logged in FDA’s internal system regardless of which specific request type it is.

A Q-Sub is advisory, not a submission FDA reviews for clearance or approval. It does not start a formal review clock, does not require a user fee, and does not commit the sponsor to anything — a sponsor can request feedback on a device concept years before a real 510(k), De Novo, or PMA is ready. What it does is put a specific, answerable question in front of FDA reviewers and get their position on the record before the sponsor spends months (or a clinical study’s worth of money) on an assumption FDA doesn’t share.

Choosing the right Q-Sub type

The Q-Sub umbrella covers several distinct request formats. Filing the wrong one for what you actually need is the single most common way sponsors waste a Q-Sub cycle.

Pre-Submission (Pre-Sub)

The default, general-purpose Q-Sub. Used before a formal marketing submission (510(k), De Novo, PMA, HDE) or an investigational device exemption (IDE) to get FDA’s written feedback on a defined set of questions — device classification and predicate selection, proposed nonclinical or clinical test methods, statistical analysis plans, or whether a planned change needs a new submission at all. A Pre-Sub can, but does not have to, request a live meeting or teleconference in addition to written feedback.

Study Risk Determination (SRD) request

A narrower, faster-turnaround request focused on one question: is a proposed clinical study significant risk (SR), nonsignificant risk (NSR), or exempt under 21 CFR 812.3(m)? Sponsors use it when the risk determination is the actual bottleneck — an NSR finding lets a study proceed under abbreviated IRB-only oversight instead of a full IDE application, so getting FDA’s read early can save months. An SRD request can stand alone or be folded into a broader Pre-Sub; standing alone is usually faster because it isn’t competing with a longer list of unrelated questions for reviewer attention. See CASRAI’s dedicated guide to IDE and the significant risk determination for the substantive 21 CFR 812 criteria this request is asking FDA to apply.

Informational Meeting

The one-way format: the sponsor briefs FDA on a new technology, an evolving development program, or an unconventional approach, without asking FDA to commit to specific written feedback. It’s the right tool when the goal is familiarizing reviewers with something genuinely novel before formal questions are ready to ask — not a substitute for a Pre-Sub when the sponsor actually needs FDA’s position on something.

Submission Issue Request (SIR)

Used only while a real 510(k), De Novo, PMA, or IDE is already under active FDA review, to request an interactive meeting or teleconference to resolve a specific deficiency FDA has already raised — for example, disagreement over what an Additional Information request is actually asking for. It isn’t available before a submission exists, and it isn’t a way to get pre-submission feedback under a different name.

Day 100 Meeting

Offered by FDA, not requested by the sponsor, roughly 100 days into an original PMA or HDE review to discuss review status and any significant deficiencies identified so far. Sponsors don’t file this as a Q-Sub; it’s mentioned here because it’s easy to confuse with the sponsor-initiated types above.

What goes into a Pre-Submission package

A Pre-Sub is a written package, not a meeting request form. At minimum it needs: a clear description of the device (intended use, indications for use, technological characteristics), the regulatory history and current status of the device and any predicate, a concise summary of the specific topic(s) the sponsor wants addressed, and the actual questions — numbered, specific, and limited to what genuinely needs FDA’s input. If a meeting is requested, the package should also propose the format (in-person, teleconference, or video) and suggested dates, and list the sponsor’s own attendees and their roles.

Padding a Pre-Sub with background material FDA doesn’t need, or with questions the sponsor could answer from published guidance, doesn’t buy goodwill — it buys a longer package for reviewers to read before they get to the parts that matter, and less reviewer attention per real question.

Writing questions FDA will actually answer

The single biggest lever a sponsor controls in a Pre-Sub is question quality. FDA reviewers answer the question as asked — a vague or compound question gets a vague or partial answer, and that answer is the artifact the sponsor is left holding when planning the real submission.

• Ask one thing per question. “Is our proposed bench and animal testing plan adequate to support substantial equivalence, and is our predicate appropriate?” is two questions wearing one question mark. Split them — a reviewer who disagrees with the predicate but not the test plan will often just answer the part they can, and the sponsor won’t know which half got addressed.
• Propose an answer, don’t just ask FDA to design the study. “What testing do we need?” invites a hedge. “We propose bench testing per [specific method/standard] and no animal testing, because [specific rationale]. Does FDA agree this is adequate to support substantial equivalence?” gives FDA something concrete to agree or disagree with, and a disagreement comes with the reason attached.
• Give FDA the information it needs to answer, in the question’s own context — don’t make a reviewer hunt through 40 pages of background to figure out what’s actually being asked. Restate the load-bearing fact next to the question that depends on it.
• Ask what actually determines your submission strategy, not everything you’re curious about. A Pre-Sub with 15 questions across five unrelated topics gets read once and answered thinly across all of them; a Pre-Sub with 3-5 questions that genuinely gate the next 12 months of work gets real reviewer attention on each.

FDA’s written feedback typically answers, restates a concern, or defers with a reason — rarely a bare “yes.” Read a hedge or a conditional answer as real information: it usually means the sponsor’s proposed approach is close but missing something specific, not that the question was badly asked.

The feedback timeline

FDA’s own performance target for a standard Pre-Submission — set out in the Q-Submission Program guidance and reinforced by the device user-fee (MDUFA) performance goals CDRH reports against — is to send written feedback and/or schedule the requested meeting within roughly 70 calendar days of receiving a complete Pre-Sub. If a meeting is requested, FDA’s practice is to send written preliminary feedback a few business days ahead of the meeting itself, so the meeting can focus on discussion rather than a first read of FDA’s position.

Two things commonly extend that clock in practice, and neither is unusual enough to be worth panicking over: an incomplete or unclear package can trigger a request for more information before the clock meaningfully starts, and FDA can decline to hold a meeting (offering written feedback only) when it judges a live discussion won’t add anything past its written response — this happens more often for narrowly scoped SRD requests than for full Pre-Subs. This timeline figure reflects FDA’s published performance-goal framework as understood at the time of writing; sponsors relying on it for planning purposes should confirm the current target against FDA’s own guidance page, since MDUFA performance commitments are renegotiated on a multi-year cycle.

How binding is Q-Sub feedback — really?

This is the part sponsors most often get wrong in both directions. Pre-Sub feedback is real, usable, and reviewers are expected to be consistent with it — but FDA is explicit that it is not a binding commitment on the eventual formal submission’s outcome, for several concrete reasons:

• The review team can change. The reviewer or branch that gave Pre-Sub feedback isn’t guaranteed to be the same team that reviews the actual 510(k)/De Novo/PMA months or years later.
• Feedback is scoped to what was asked, as described. If the final submission’s device, indications, or testing differ from what was represented in the Pre-Sub — even in ways that seem minor to the sponsor — the earlier feedback no longer straightforwardly applies.
• The regulatory landscape can move. A new recognized consensus standard, an updated guidance document, or a new safety signal identified across the device type between the Pre-Sub and the formal submission can change FDA’s position even where nothing about the sponsor’s own device changed.
• Pre-Sub feedback is not a pass/fail review. FDA is telling the sponsor its current thinking on a proposed approach, not pre-clearing or pre-approving a device that doesn’t exist yet as a completed submission.

In practice, this cuts both ways for a sponsor’s planning: don’t treat a favorable Pre-Sub answer as a guarantee the eventual submission will sail through unchanged — but don’t discount the feedback either. A submission that follows through on what was actually agreed, documents any deviation and why, and doesn’t quietly change scope between Pre-Sub and filing is the version of “binding” a Q-Sub realistically offers: consistency is FDA’s stated expectation of its own review teams, not the sponsor’s contractual right.

Common Q-Sub mistakes worth avoiding

• Filing a Pre-Sub with no real question. “Please confirm our overall regulatory strategy is sound” isn’t answerable — FDA will ask the sponsor to resubmit with specific questions, costing a full cycle.
• Treating an Informational Meeting as a shortcut to feedback. It’s one-way by design; asking FDA to commit to a position in that format is a category error that gets deferred to “please submit as a Pre-Sub.”
• Skipping the SRD request and guessing at significant-risk status. Guessing wrong either delays a study behind an IDE application that wasn’t actually required, or starts a study under IRB-only oversight that FDA later disagrees should have had an IDE — both are expensive to unwind mid-study.
• Not updating FDA when the device or plan changes after a Pre-Sub. Silence reads as “nothing changed”; a formal submission that surprises the same review division with a materially different device than the one discussed burns the goodwill the Pre-Sub was meant to build.

Frequently asked questions

Do I need a Pre-Sub before every 510(k), De Novo, or PMA?

No — it’s optional, and plenty of straightforward 510(k)s for well-established device types with a clean predicate go straight to submission. A Pre-Sub earns its cost when there’s genuine uncertainty: a novel predicate comparison, an unusual test method, a first-in-kind device, or a study design with real cost/risk riding on FDA agreeing with it in advance.

How is a Study Risk Determination request different from a Pre-Sub?

An SRD request asks one narrow question — SR, NSR, or exempt under 21 CFR 812.3(m) — and can move faster because it isn’t competing with a broader question list. A Pre-Sub can ask the same risk-determination question alongside other topics, but folding it in usually means a longer package and a longer wait for that one answer.

Can I request a meeting without submitting a Pre-Sub package first?

No — a meeting or teleconference is requested as part of a Q-Sub package (a Pre-Sub, an SRD request, or an SIR for an active submission), not on its own. FDA reviews the written package first and decides whether a meeting adds value on top of written feedback.

What happens if FDA disagrees with our proposed approach in a Pre-Sub?

FDA’s written feedback will say so and typically explain why, sometimes pointing to a specific guidance document, recognized standard, or prior safety concern. That’s the outcome a Pre-Sub exists to surface early — before a study is run or a submission is filed on an assumption FDA doesn’t share, not after.

Is Q-Sub feedback the same as FDA “pre-clearing” a device?

No. Feedback addresses the specific questions asked about a proposed approach; it is not a review of a completed submission and does not predict the outcome of one. See “How binding is Q-Sub feedback — really?” above.

Related CASRAI resources

For the broader classification and pathway decision a Q-Sub often supports, see FDA medical device regulations: classification, 510(k), and PMA pathways and the 510(k) vs. PMA comparison. For the risk-determination substance behind an SRD request, see IDE and the significant risk determination. For device-specific FDA programs sponsors often raise inside a Pre-Sub, see predetermined change control plans, premarket cybersecurity, and human factors and usability engineering. For quality-system risk analysis referenced throughout premarket testing plans, see ISO 14971. For the parallel drug-side meeting framework (not the device Q-Sub program), see FDA meeting types: Type A, B, C, and D.