The Q-Submission Program
The Q-Submission Program is how a manufacturer asks FDA for feedback before making a submission. The most common type is a Pre-Submission, in which specific written questions are put to FDA and FDA responds in writing. It is voluntary, it carries no FDA user fee, and it is most valuable before expensive testing has been commissioned rather than after.
FDA Q-Submission Program guidance, 29 May 2025
At a glance
| What it is | A formal written request for FDA feedback on specific questions, with an optional meeting. |
|---|---|
| FDA user fee | None. Q-Submissions do not appear in the MDUFA fee schedule. |
| Written feedback goal | Within 70 calendar days of the review clock start, or at least 5 days before a scheduled meeting, whichever is sooner. |
| Meeting | Optional and additional. Typically day 70 to 75, by mutual agreement. |
| How many questions | FDA states the most effective Pre-Subs have no more than 7 to 10 questions, across no more than four substantial topics. |
| Is the feedback binding? | No. But FDA states it does not intend the feedback to change, provided the later submission is consistent with what was described. |
| What it is not for | Pre-review of data, study design requests, classification questions, or asking whether a submission will succeed. |
| Clock start | The review clock starts on receipt of a valid eSTAR or eCopy, not on the date you send it. |
The submission types
Covered in detail by the guidance:
- Pre-Submission — the main route. Written questions, written answers, optional meeting.
- Submission Issue Request — for feedback on how to address a hold or deficiency on a submission already filed.
- Study Risk Determination — whether a planned study is significant risk, non-significant risk, or exempt.
- Informational Meeting — to share information with FDA without asking for feedback.
- PMA Day 100 Meeting.
Also tracked in the program:
- Agreement and Determination Meetings, under the FDAMA early collaboration guidance.
- Breakthrough Devices Program designation requests and interactions.
- Safer Technologies Program entrance requests and interactions.
- Accessory Classification Requests.
Appeals, Requests for Designation, 513(g) Requests for Information, Emergency Use Authorization requests and TAP Pilot interactions are all outside the Q-Submission Program. FDA lists them separately.
The questions FDA will and will not answer
A Pre-Submission is appropriate where FDA feedback on specific questions would help guide development or submission preparation. FDA states plainly that it is not intended to be a pre-review of an intended submission, nor of the data that will go in it.
FDA does not recommend:
- Questions about the final outcome — "will this proposal support a determination of substantial equivalence?"
- Questions asking FDA to design the study — "what should my clinical study design be?"
- Requests for a formal regulatory determination — "is my device Class II under 21 CFR 892.2050?" That is a 513(g).
- Requests for a pre-review of data.
FDA states that feedback is most effective when requested before planned testing is executed. It also specifically recommends a Pre-Submission for feedback on a Predetermined Change Control Plan before that plan goes into a marketing submission.
What the feedback is worth
FDA guidance does not establish rights for any person and is not binding on FDA or the public. Review of information in a Pre-Submission does not guarantee a favorable decision in a future submission.
FDA states that it intends the feedback given in response to a Pre-Submission will not change, provided the information in the later submission is consistent with what was provided in the Pre-Submission, and provided new information, changes in the science, or changes in the standard of care do not raise important new issues materially affecting safety or effectiveness. Where FDA does change its advice, it commits to acknowledging the change, documenting the rationale, and supporting the determination with management concurrence.
Questions people ask
How long does a Pre-Submission take?
FDA aims to provide written feedback within 70 calendar days of the review clock start date. If a meeting is requested, written feedback arrives at least 5 days before the meeting and no later than day 70, with the meeting typically between day 70 and 75.
Does it cost anything?
There is no FDA user fee. Q-Submissions do not appear anywhere in the MDUFA fee schedule, which lists only 510(k), 513(g), PMA and related application types.
How much time does it add to a project?
FDA does not publish a figure for this. What FDA does state is the component timings: technical screening within 15 days, a meeting date agreed within 30 days, written feedback by day 70, and minutes finalized 15 days after FDA sends its edits.
Can we ask FDA what class our device is in a Pre-Sub?
No. FDA states that a request for information about classification and applicable regulatory requirements is not within the scope of a Pre-Submission. That question is governed by section 513(g).
Do we have to do what FDA says in the response?
No. FDA states that issues it raises in a Pre-Submission do not obligate the submitter to address or resolve them in a later submission. Whether that is wise is a separate question.