FDA Q-Submission consulting is outside help to plan, write and run a Pre-Submission, the free and voluntary request for FDA's written feedback on your plans before you file. You can file one yourself, but help matters most when your pathway, predicate or test plan is still open, and when you need questions FDA can actually answer.
Key takeaways
- A Pre-Sub carries no FDA user fee. FDA aims to send written feedback within 70 days, and met that goal for 97.5% of CDRH Pre-Subs in fiscal year 2025, by its preliminary count.
- FDA says its feedback is most effective before you run your planned testing, and that the most effective Pre-Subs typically have no more than 7 to 10 questions.
- FDA will not design your study or confirm your device class in a Pre-Sub. You make a proposal with a rationale, and FDA comments on it.
- FDA intends its feedback not to change if your later submission stays consistent with the Pre-Sub. It still does not guarantee a favorable decision.
- We analyzed FDA's own data: CDRH counted 4,344 Pre-Subs in fiscal year 2025, about 15% more than in 2023.
What does FDA Q-Submission consulting cover?
It covers any of the formal ways to ask FDA for feedback or a meeting about a device submission. FDA calls these Q-Submissions, or Q-Subs [1]. Most consulting work is on the Pre-Submission, or Pre-Sub, but there are several types:
| Q-Sub type | What you get | FDA's timeframe |
|---|---|---|
| Pre-Submission | Written feedback, or written feedback followed by a meeting | Feedback within 70 days, or 5 days before the meeting if sooner. Meeting typically on day 70 to 75 |
| Submission Issue Request (SIR) | Feedback on how you plan to answer a hold letter or similar FDA letter | 21 days if sent within 60 days of FDA's letter, as resources permit. 70 days otherwise |
| Study Risk Determination | FDA's decision on whether a planned clinical study is significant risk, nonsignificant risk or exempt | 90 days |
| Informational Meeting | A meeting to share information with FDA, with no feedback expected | 90 days |
| PMA Day 100 Meeting | A meeting on the status of a filed PMA | 100 days from the PMA filing date |
Source: FDA's Q-Submission guidance, Table 1 [1]. Our Q-Submission hub explains the program, and our step-by-step Q-Sub guide walks through filing one. This article is about a different question: when outside help is worth it, and how to tell good help from bad.
Do you need a consultant for a Pre-Sub?
No. The program is voluntary, and nothing in it requires a consultant [1]. FDA does expect that some submitters use one. Its guidance asks for contact details for the submitter and for the correspondent, "e.g., consultant", if they are different [1]. Your company stays the submitter. You can add, change or remove a consultant later with an amendment [1].
Outside help tends to earn its place in these situations:
- Your pathway is open. You have no clear predicate, or you may need a De Novo request. FDA's own example questions include whether a proposed predicate is appropriate and whether FDA knows of other predicates to consider [1]. See our guides to predicate devices and the De Novo pathway. If you are still choosing a pathway, Complizen's Regulatory Strategy service writes a strategy that sets your device's classification, pathway and predicates, and recommends a Pre-Sub where the pathway question is genuinely open.
- You plan a clinical study. FDA says it cannot prepare or design study plans for you. You send a proposed outline with a rationale and specific questions [1]. Our IDE guide covers the study side.
- You plan a PCCP. FDA says Pre-Subs are highly recommended for feedback on a Predetermined Change Control Plan before it goes into a submission [1]. See our PCCP guide and our article on Pre-Subs for software devices.
- You are about to spend on testing. FDA says feedback is most effective when you ask before running the planned tests [1]. A question about an animal model or a test method is worth more before the study than after it.
- Your team has not written to FDA before. FDA asks for Q-Subs in English, and you draft the meeting minutes, not FDA [1]. FDA says virtual meetings are usually the most efficient, so a team outside the US can take part without travel [1].
When a Pre-Sub is the wrong tool. FDA says a Pre-Sub is not a pre-review of your submission or of your data [1]. If you want FDA's written view on your device's class and the requirements that apply, the route is a 513(g) request for information [1, 7]. Unlike a Pre-Sub, it has a fee: $8,596, or $4,298 for a small business, in fiscal year 2027 [4]. If you already have an Additional Information letter on a pending 510(k), the Q-Sub type for discussing your planned answer is a SIR. FDA says a SIR is not appropriate for a Not Substantially Equivalent letter, or while a file is under active review [1]. Our guide to answering FDA's additional information requests covers the response itself.
What does a Pre-Sub cost, and how long does it take?
FDA charges nothing for it. Pre-Subs are not on FDA's list of device user fees for fiscal year 2027, which runs from October 1, 2026 to September 30, 2027 [4]. Your cost is the time to prepare it, and any outside help.
FDA's timeline runs like this [1, 8]:
| Step | Who | When |
|---|---|---|
| Acceptance review, or technical screening for an eSTAR | FDA | Within 15 days of the review clock starting |
| Confirm one of your meeting dates, or offer at least two others | FDA | With the acceptance notice. Alternative dates fall before day 75 |
| Agree the meeting date | Both | FDA intends to agree a date by day 30. If not, an FDA manager contacts you by day 40 |
| Send draft slides | You | At least 2 days before the meeting |
| Written feedback | FDA | Within 70 days, or 5 days before the meeting if sooner |
| Meeting | Both | Typically day 70 to 75 |
| Draft minutes | You | Within 15 days of the meeting |
| Edits to your minutes, if any | FDA | FDA intends to send them within 30 days |
| Minutes become final | Both | 15 days after you receive FDA's edits, unless you disagree |
The clock can restart. The review clock starts when FDA receives a valid eCopy or an eSTAR. If FDA finds the request is incomplete, or does not qualify as a Pre-Sub, it places it on a Refuse to Accept or technical screening hold and tells you why. When you respond, the clock restarts at day 0 [1]. FDA's acceptance checklist is Appendix 1 of the guidance, so check your package against it before you send it.
Pick realistic meeting dates. FDA says dates 70 to 75 days after it receives your request are the most likely to be feasible [1].
Plan for the full cycle. If every step uses its full time, a Pre-Sub with a meeting runs like this: the meeting by about day 75, your draft minutes by day 90, FDA's edits within 30 days after that, and final minutes 15 days later, around day 135 [1]. These are FDA's targets, counted from the review clock start, not guarantees. If you ask for written feedback only, it is due by day 70.
How you file. Q-Subs are subject to FDA's eCopy rules, and FDA recommends sending them through the CDRH Portal [1, 6]. An eSTAR template for Pre-Subs, called PreSTAR, exists. Its current version is 3.1, and FDA lists it as voluntary. It now also covers other Q-Sub types, such as SIRs and Study Risk Determinations [5]. Meeting minutes and slides still go in eCopy format through the CDRH Portal [5]. Our eSTAR guide explains the template family.
How busy is FDA's Pre-Sub program?
Busier each year from 2023 to 2025, and FDA has kept to its feedback goal. We analyzed FDA's MDUFA performance dataset for Pre-Subs at CDRH, the center that reviews most devices [2, 3]:
| Fiscal year | Pre-Subs counted at CDRH | Feedback within goal | FDA's goal |
|---|---|---|---|
| 2023 | 3,780 | 98.8% | 75% |
| 2024 | 4,095 | 98.7% | 90% |
| 2025 | 4,344 | 97.5% | 90% |
| 2026, to June 30 | 3,191 | 96.9% so far | 90% |
The "within goal" share is FDA's own figure. It leaves out Pre-Subs still inside their 70-day window. FDA marks fiscal years 2025 and 2026 as preliminary, as of June 30, 2026 [2]. CBER, FDA's biologics center, which also reviews some devices, counted 74 more in fiscal year 2025 [3].
Three things stand out:
- Volume grew about 15% in two years, from 3,780 to 4,344.
- The goal depends on volume. Under the MDUFA V commitment, FDA's goal is 90% within 70 days. In fiscal year 2023 the goal dropped to 75% because volume passed a set threshold, and the goal covers up to 4,300 Pre-Subs a year [8]. In fiscal year 2025, 4,261 of CDRH's Pre-Subs fell in the group the goal measures [3].
- Pre-Subs now rival 510(k)s. FDA cleared about 3,200 510(k)s in calendar year 2025 [9]. The periods differ, and Pre-Subs also prepare De Novo, PMA and study submissions, so this is only a rough comparison. It still suggests that asking FDA first is common practice.
For your plan, this means FDA usually meets its 70-day target. The parts you control matter more: a complete package that avoids a hold, and questions FDA can answer.
What does a good Pre-Sub package include?
A focused one. FDA says extraneous information can be counterproductive, and recommends a targeted, focused submission [1]. The guidance lists what to include [1]:
In the cover letter:
- contact details for your company and your consultant, if you use one
- the Q-Sub type, one type per submission
- the feedback you want: written only, or written followed by a meeting
- for a meeting: a draft agenda with time per item, the format, three or more preferred dates, and the planned attendees with their roles
In the body:
- Purpose: what you want from the interaction
- Device description: how it works, the science behind it, key physical and performance traits, and manufacturing details if they may affect testing
- Proposed indications for use: the condition, the body function affected, and the patient population
- Regulatory history: earlier FDA submissions and Q-Subs for the device, with their numbers and what came of them
- Background: only what the questions need, with a note on which question it supports
- Specific questions: clear questions tied to your planned submission
FDA prefers one Q-Sub at a time for a device. Later topics can go in Q-Sub supplements, once the current priority is answered [1].
What makes a good Pre-Sub question?
One that asks FDA to react to your proposal. FDA's guidance says the most valuable questions [1]:
- ask for feedback on a specific proposal, with your rationale
- cite the relevant guidance, standards and any earlier FDA feedback
- state the outcome you want, such as an indication for use or a labeling claim
- arrive before the testing they are meant to shape
FDA's examples show the difference [1]:
| Ask this | Not this |
|---|---|
| "Is the proposed predicate device appropriate if we demonstrate substantial equivalence?" | "Will this proposal support a determination of substantial equivalence?" |
| "Is FDA aware of any additional predicate devices that we should consider?" | "Can FDA confirm my device is eligible for a 510(k) or De Novo?" |
| "Based on the regulatory strategy and discussion of pre-clinical testing provided, does FDA concur that clinical data is likely not needed to support a future 510(k)?" | "What should my clinical study design be?" |
| Feedback on a proposed animal model, with your rationale | "Does FDA have any other feedback on my clinical study?" |
Use one pattern. State your proposal, name the guidance or standard behind it, point to your rationale or protocol outline, then ask whether FDA agrees. FDA's own example: "To address FDA's deficiency regarding our sterilization validation, we propose using Small Lot Release in accordance with Annex E of ISO 11135-2014. Does FDA have objections?" [1]
Keep it short. FDA says the most effective Pre-Subs typically have no more than 7 to 10 questions, counting sub-questions, across no more than four substantial topics [1]. Add data only when a proposal needs it as context. FDA's example is one page of early feasibility results, sent with a question on proposed pivotal study endpoints [1].
If you would rather start from a draft than a blank page, Complizen's Q-Sub Preparation drafts the package, helps shape your questions, and updates your submission plan once you upload FDA's written response.
How do you judge a Pre-Sub consultant?
By how closely their plan matches what FDA says works. Ask these questions before you hire anyone:
- Will you tell me if I do not need a Pre-Sub? The program is voluntary [1]. Good help starts by asking whether a Pre-Sub, a 513(g), or no request at all fits your question.
- Can I see a sample question? Look for a proposal, a rationale and references to guidance and standards, not an open question.
- How many questions will we ask? A plan for 25 questions works against FDA's 7 to 10 [1].
- Where does this fit in my test schedule? The answer should be before the tests the questions are about [1].
- Who takes the minutes? You are responsible for drafting them within 15 days. FDA also asks you to say so at the start and end of the meeting [1, 8].
- What happens after the feedback? You want a plan that updates your test strategy and records any point where you will take a different approach.
- Who writes the questions? Ask whether the people drafting them have direct FDA submission experience.
Red flags:
- a promise that FDA will agree, or that the Pre-Sub ensures clearance. FDA says its review of a Pre-Sub does not guarantee a favorable decision [1]
- questions that ask FDA to confirm your class or pathway
- a plan to file after the testing is done
- no plan for slides, minutes or follow-up
What happens after FDA's feedback?
You turn it into decisions. Before the meeting, two rules from FDA's guidance matter [1]:
- You can cancel the meeting. If the written feedback answers your questions, you may cancel, and the written response becomes the official record.
- Do not send new data before the meeting. FDA says it should not be expected to review information sent between its feedback and the meeting. You can narrow the agenda to the points in the feedback. Anything that needs new review goes in a Q-Sub supplement or your eventual submission.
After the meeting, FDA's feedback shapes your testing and your submission, within limits [1]:
- It does not bind you. Issues FDA raises do not oblige you to address them. But a later submission on that topic should explain why you chose a different approach or left an issue open [1].
- FDA intends to stand by it, with conditions. FDA intends its feedback not to change if your later submission is consistent with the Pre-Sub, and no new information, science or standard of care raises important new safety or effectiveness issues [1]. So keep the device you describe in the Pre-Sub and the device you submit the same, or explain what changed.
- It does not guarantee the outcome. FDA may still raise new questions when it reviews the full submission [1].
- Minutes summarize, not transcribe. They record key points, agreements and action items, and attribute statements to the submitter or FDA, not to individuals. Attendees should not record the meeting. Appendix 3 of the guidance shows an example format [1].
- Disagreements on the minutes have a process. If FDA's edits misstate a significant issue, you file a "meeting minutes disagreement" amendment, and FDA sets up a call to resolve it [1].
- The file stays. You cannot withdraw a Q-Sub after FDA gives feedback and closes it. You are also not required to file a follow-on submission [1].
- Confidentiality has limits. FDA keeps the existence of a Q-Sub confidential, subject to the law. Minutes and meeting materials are still subject to disclosure review under the Freedom of Information Act [1].
If FDA's answers raise new topics, a Q-Sub supplement lets you continue the conversation without starting over [1].
Frequently asked questions
What does FDA Q-Submission consulting include?
FDA Q-Submission consulting usually covers deciding whether a Pre-Sub is worth it, drafting the package, writing questions FDA can answer, preparing slides, running the meeting and drafting the minutes. Good help also turns FDA's written feedback into an updated test plan, and records where you will take a different approach.
Is a Pre-Sub required before a 510(k)?
No. The Q-Submission program is voluntary, and you can file a 510(k) without one. FDA says a Pre-Sub fits when its feedback on specific questions would help guide device development or submission preparation. FDA highly recommends one before including a Predetermined Change Control Plan in a submission.
Does FDA charge a fee for a Pre-Sub?
No. Pre-Subs are not on FDA's list of device user fees for fiscal year 2027. Your costs are your own preparation time and any outside help. A 513(g) request for classification information does have a fee: $8,596, or $4,298 for a qualifying small business, in fiscal year 2027.
How long does FDA take to respond to a Pre-Sub?
FDA aims to send written feedback within 70 days of receipt, or 5 days before a scheduled meeting if that is sooner. Meetings typically fall on day 70 to 75. In fiscal year 2025, CDRH met its feedback goal for 97.5% of Pre-Subs, according to FDA's preliminary data.
Can a consultant submit a Pre-Sub on my behalf?
Yes. FDA's guidance asks for contact details for the submitter and for the correspondent, such as a consultant, if they differ. Your company remains the submitter of record. You can add, change or remove a consultant later by sending FDA an amendment that names the new correspondent.
How many questions should a Pre-Sub include?
FDA says the most effective Pre-Subs typically have no more than 7 to 10 questions, including sub-questions. These usually sit under no more than four substantial topics. If you have many questions on one topic, FDA suggests a Pre-Sub on that single topic, with later topics in supplements.
Can a Pre-Sub confirm my device class or pathway?
Not formally. Pathway can be a topic of discussion, but FDA advises against questions such as "Can FDA confirm my device is eligible for a 510(k) or De Novo?" For FDA's written view on your device's class and requirements, use a 513(g) request for information, which has its own fee and procedure.
Is FDA's Pre-Sub feedback binding?
Not in the usual sense. Issues FDA raises do not oblige you, but a later submission should explain a different approach. FDA intends its feedback not to change if your later submission is consistent with the Pre-Sub and no important new safety or effectiveness issues arise. It still does not guarantee a favorable decision.
Do I have to use PreSTAR?
No. PreSTAR, the eSTAR template for Pre-Subs, is voluntary, and its current version is 3.1. Q-Subs must still meet FDA's eCopy rules. FDA recommends sending them through the CDRH Portal. With an eSTAR, a request counts as accepted once it passes technical screening.
Who writes the Pre-Sub meeting minutes?
You do. You send draft minutes to FDA within 15 days of the meeting, as an amendment. FDA intends to send any edits within 30 days. The minutes become final 15 days after you receive FDA's edits, unless you file a disagreement about a significant issue.
When is the best time to submit a Pre-Sub?
Before you run the testing your questions are about. FDA says its feedback is most effective when requested before planned testing. FDA aims to send feedback within 70 days of receipt, and a meeting adds minutes and edits after that. File early enough that the answers arrive before you commit to protocols.
Can I request a Pre-Sub for an AI device with a PCCP?
Yes, and FDA highly recommends it. FDA's Q-Submission guidance says Pre-Subs are highly recommended for feedback on a Predetermined Change Control Plan before it goes into a premarket submission. A PCCP describes planned device changes. Once FDA authorizes it, changes within its bounds need no new 510(k) or PMA supplement.
References
- FDA. Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. Final guidance issued May 29, 2025.
- FDA. FDA-TRACK: MDUFA Quarterly Performance Dashboards, Pre-Submissions. Content current as of June 30, 2026.
- FDA. MDUFA Pre-Submissions dataset. Data as of June 30, 2026, accessed October 9, 2026.
- FDA. Medical Device User Fee Amendments (MDUFA), fiscal year 2027 fee table. Content current as of October 1, 2026.
- FDA. eSTAR Program. Content current as of September 21, 2026.
- FDA. Send and Track Medical Device Premarket Submissions Online: CDRH Portal. Content current as of December 5, 2025.
- FDA. FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act. Final guidance, August 2024.
- FDA. MDUFA V Commitment Letter, Section II.A, Pre-Submissions. 2022.
- openFDA. 510(k) API, decisions dated January 1 to December 31, 2025. Accessed October 9, 2026.