We prepare FDA Q-Submissions for medical device and IVD manufacturers, from choosing the Q-Sub type through the questions to the meeting minutes. In a Pre-Sub, the FDA answers specific questions on your proposal; it does not pre-review data or decide on classification.
Overview
Q-Submission Program for medical devices and IVD · FDA guidance of May 29, 2025 · Pre-Sub, SIR, Study Risk Determination, Informational Meeting, PMA Day 100 Meeting · 21 CFR 812.2
Last updated: November 1, 2026
The FDA answers in a Pre-Sub only what it was asked, and only for the information it was given. Most weak answers trace back to the request itself.
Industries
Services
Choosing the type that fits the question: Pre-Sub before a planned submission, Submission Issue Request after a hold letter, Study Risk Determination for a clinical investigation, Informational Meeting without feedback. Several Q-Subs for one device are planned as an original with supplements, one at a time, with the overview of further Q-Subs in the first.
Turning open questions into proposals the FDA can answer: a proposed test method, animal model or endpoint with its rationale, references to guidance, standards and earlier FDA feedback, and the labeling claim the evidence is meant to support. Deliverable: a list of no more than ten questions, each naming the decision in the project it informs.
Cover letter with Q-Sub type, method of feedback and, for a meeting, draft agenda, format, three or more dates and the planned attendees; in the body purpose, device description, indications for use, regulatory history and the planned follow-on submission. Background goes in where a question needs it, in English, as an eCopy or voluntarily as a PreSTAR.
Reading the written feedback, which arrives at least 5 days before the meeting, and narrowing the agenda to the questions it leaves open. Slides go to the FDA at least two days ahead; the meeting is normally limited to one hour. Where statistics are on the agenda, the request can suggest that an FDA statistician attend.
Drafting the minutes as an amendment within 15 days of the meeting: discussion summarized, agreements and action items listed, statements assigned to the FDA or the company, not to individuals. Afterwards the feedback goes into the test plan and, in the later submission, into a section that cites the Q-Sub and explains how each point was addressed.
After an Additional Information letter for a 510(k) or De Novo, a Major Deficiency letter for a PMA or an IDE letter: a SIR on the planned approach, with the deficiencies named and, where new data are planned, a proposed protocol with its rationale. Written feedback or a meeting, not both; the due date of the response stays where it is.
How we work together
A Q-Submission is the FDA's tracking system for requests for feedback or a meeting on a medical device submission. The guidance of May 29, 2025, covers five types in detail; others, such as Breakthrough designation requests or STeP entrance requests, run through the same system under their own guidance. Taking part is voluntary, and no Q-Sub obliges the manufacturer to file a later submission.
| Q-Sub type | For what | How the FDA answers | Timeframe in the guidance |
|---|---|---|---|
| Pre-Submission | specific questions before a planned IDE, 510(k), De Novo request, PMA, HDE or CLIA waiver | written feedback, optionally followed by a meeting | 70 days, or 5 days before the meeting if that is sooner |
| Submission Issue Request | the approach to the deficiencies in a hold letter | written feedback or a meeting | 21 days if received within 60 days of the letter, otherwise 70, as resources permit |
| Study Risk Determination | whether a planned clinical investigation is significant risk, nonsignificant risk or exempt | formal letter | 90 days |
| Informational Meeting | information for the FDA without feedback, for instance on several submissions planned in the next 6 to 12 months | meeting | 90 days, as resources permit |
| PMA Day 100 Meeting | the review status of a filed PMA | meeting, with the deficiencies found so far in writing beforehand | 100 days from the filing date |
The first Q-Sub for a device and its indications for use becomes the original; at CDRH it receives a number such as Q180001. Every further request on the same device is a supplement (Q180001/S001), every addition without a new request, such as slides or minutes, an amendment. The guidance recommends one Q-Sub per device at a time, because feedback on one can change the answers to another.
The Pre-Sub is not a pre-review. The FDA does not review data in it, does not design studies and does not discuss a file it is currently reviewing; that runs through interactive review. Its answer is best advice at a point in time, which is why the FDA finds feedback most useful before planned testing starts.
This page leaves out the choice of pathway and the programs Breakthrough, STeP and TAP, both covered on FDA Strategy & Pathways, as well as the submissions the Pre-Sub prepares: 510(k), De Novo and PMA. Meetings for medicinal products are described under Health Authority Interaction.
Our approach
Step
Result
Set the goal and the type
One Q-Sub type, the follow-on submission it prepares, and the place of this Q-Sub in the sequence for the device.
Formulate the questions
Up to four substantial topics with a proposal, rationale and references for each question.
Submit and pass acceptance
A Pre-Sub that passes acceptance review or technical screening, with a confirmed or offered meeting date.
Prepare and hold the meeting
An agenda reduced to the open points, slides at the FDA two days ahead, and a team that knows who answers which question.
Record and apply
Minutes submitted within 15 days and FDA feedback built into the test plan and the later submission.
Common pitfalls
New data are shown for the first time in the meeting.
The FDA should not be expected to review information it receives between its written feedback and the meeting; anything that needs review belongs in a Q-Sub supplement or in the later submission.
Silence is read as agreement.
The FDA does not discuss topics outside the Pre-Sub questions; if its feedback does not mention a topic, information on that topic may still be needed in the later submission, even if it was in the Pre-Sub.
The later submission does not name the Q-Sub.
Without the reference in the cover letter, the FDA does not link the two in its records, and finding the earlier feedback can delay the review. The submission also needs a section on how the feedback was addressed, including where a different approach was chosen.
The study starts on feedback more than a year old.
If more than one year has passed since FDA feedback on significant study design topics and the study has not begun, the guidance recommends confirming with the review division that the advice still applies.
Regulatory Affairs
In a first call we assess your situation and say what needs clarifying first in your case. Without obligation, reply usually within one working day.
FAQ
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Projects from this industry
Latest insights
All insights →FDA Strategy & Pathways →
Choosing between 510(k), De Novo and PMA, and Breakthrough, STeP and TAP
510(k) Premarket Notification →
The 510(k), for which a Pre-Sub can test whether the proposed predicate fits
De Novo Classification →
The De Novo request; a Pre-Sub can ask whether the FDA knows of further predicates
Premarket Approval (PMA) →
The PMA, whose Day 100 Meeting the FDA tracks as a Q-Sub
Qualification & Classification →
Classification questions that belong in a 513(g) request, not a Pre-Sub
Health Authority Interaction →
Meetings with the EMA and the FDA for medicinal products
Briefly outline your situation. We'll respond with an initial assessment, usually within one business day.
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