FDA Pre-Submission (Q-Sub) Meetings: How to Prepare and Use FDA Feedback

Few regulatory tools save as much time and money as an early conversation with FDA. The Q-Submission (Q-Sub) program, and in particular the Pre-Submission (Pre-Sub), lets a manufacturer ask FDA specific questions about a planned submission before committing to a pivotal study, a test protocol or a pathway. A well-prepared Pre-Sub can prevent a failed study or a deficiency letter months later; a poorly prepared one wastes a meeting. This guide explains what the Q-Sub program offers, when to use it, how to write a strong request and how to use FDA’s feedback.

What the Q-Submission program is

“Q-Submission” is the umbrella name for several ways to request feedback and meetings from FDA’s device centers about planned or ongoing medical device submissions. FDA describes the program, the content it expects and the performance goals in its guidance on requests for feedback and meetings for medical device submissions. Because the guidance is revised periodically, always check the current version before you prepare a request.

Type	Typical use
Pre-Submission	Feedback on a planned 510(k), De Novo, PMA, IDE or other submission: testing, clinical study design, predicate choice, pathway
Submission Issue Request	Discussing issues raised in an existing deficiency letter or hold, to agree how to resolve them
Study Risk Determination	Asking whether a planned study is significant or non-significant risk
Informational Meeting	Sharing information about a new technology or device without a specific premarket decision in mind
Other meeting types	Breakthrough-related and PMA process meetings, and similar interactions defined in the guidance

FDA’s classification-focused alternative is a 513(g) request for information, which is not a Q-Sub. Our article on device classification explains when it is useful.

When a Pre-Sub is worth it

A Pre-Sub is most valuable when the answer will change what you do and an incorrect assumption would be costly. Typical triggers:

• A new technology, new intended use or unusual risk profile with no clear predicate.
• Uncertainty whether a 510(k) or a De Novo request is the right pathway.
• A planned clinical study where endpoints, sample size or comparator need agreement.
• Novel test methods, alternatives to recognised standards or unusual performance claims.
• Software, AI-enabled functions or a predetermined change control plan, where FDA expectations are still developing.
• Complex human factors strategy for a high-risk user interface.

It is less useful for a straightforward device with a clear predicate and well-established testing, where a Pre-Sub may add time without adding information.

How to write a strong Pre-Sub request

Core content

• Cover letter and administrative information identifying the request type and requested meeting format.
• Device description and intended use or indications for use, with enough technical detail for a reviewer to understand how it works.
• Regulatory history including any previous interactions, predicates considered and classification reasoning.
• Specific questions with your proposed approach and rationale for each.
• Supporting data or protocols where the question concerns a protocol or an analysis.

Writing the questions

The questions are the heart of the request. Follow these rules:

1. Ask about a decision, not a topic. “Does FDA agree that bench testing to these acceptance criteria is sufficient to support substantial equivalence?” is better than “What testing is needed?”
2. State your proposed approach and your reasoning in the same section as the question.
3. Keep the number of questions manageable. A handful of well-formed questions gets better answers than a long list of vague ones.
4. Avoid asking FDA to design the programme for you. FDA gives feedback on your plan.
5. Do not bury new information in a late appendix. Put key data where the question is asked.

Include the formats FDA expects for electronic submissions and any templates or portals currently required. The submission mechanics have changed over time, so follow the guidance and FDA’s instructions at the time of filing.

What happens after you submit

1. Acknowledgement and review: FDA assigns a Q-Sub number and a lead reviewer, and checks that the request is complete enough to review.
2. Written feedback: FDA typically provides written feedback in advance of any meeting. FDA’s performance goals set a target timeframe for feedback or a meeting, so check the current goals in the guidance.
3. Meeting, if requested: use the time to clarify the written feedback, not to repeat your slides. Bring the right technical and clinical experts.
4. Meeting minutes: agree how the discussion will be documented, and ensure the record accurately reflects what FDA said and what you plan to do.
5. Follow-up: if FDA’s answer changes your plan, you can submit a follow-up Pre-Sub with the revised approach.

How binding is FDA’s feedback?

Feedback in a Pre-Sub is non-binding. FDA states that it generally intends to be consistent with its feedback unless there is a significant change in circumstances or new information, such as a public health concern. Therefore, treat the minutes as strong guidance, but also keep your own record of the data and rationale. If your design, intended use or study plan changes after the meeting, tell FDA through an update rather than assuming earlier agreement still applies. Always reference the Pre-Sub number in your later submission, and explain how you addressed each piece of feedback.

Practical tips

• Start preparing early. Writing the questions often reveals gaps in your own plan.
• Involve engineering, clinical, quality and regulatory in drafting, and have an experienced reviewer test the questions.
• Be honest about risks and uncertainties. FDA is more helpful when it can see the real concerns.
• Prepare for written-only feedback. A meeting is not guaranteed in every situation, so design the written request to stand on its own.
• Keep a tracker mapping each FDA comment to your response and the evidence you generated.
• Link your Pre-Sub plan to your overall regulatory strategy so questions are timed to when answers are needed.

Common mistakes

• Submitting too late, after the study protocol is already locked.
• Asking broad questions that FDA cannot answer without a plan.
• Providing incomplete device descriptions, so reviewers must guess.
• Treating feedback as approval of the final design or data.
• Failing to cite the Pre-Sub and its feedback in the eventual submission.
• Not updating FDA when the plan changes materially.

Frequently asked questions

Is a Pre-Sub required before a 510(k)?

No. Q-Submissions are voluntary. They are a tool to reduce uncertainty, not a prerequisite for a 510(k), De Novo or PMA submission.

Does FDA charge a fee for a Pre-Sub?

Q-Submissions generally do not carry a user fee, unlike many marketing submissions. Fee rules can change, so confirm in the current guidance and fee schedule.

Can I include a draft clinical protocol in a Pre-Sub?

Yes, and it is common. Protocols are best submitted with specific questions on endpoints, sample size, comparators and statistical analysis so FDA can focus its feedback.

What if I disagree with FDA’s feedback?

You can ask for clarification, submit a follow-up Pre-Sub with additional data or rationale, or, in some cases, pursue dispute resolution options described by FDA. Document your reasoning and keep the discussion constructive.

FDA guidance and performance goals are revised from time to time. Confirm the current Q-Submission guidance, submission method and timelines on FDA’s website before filing.

Related reading

• The 510(k) submission process: what the final submission contains.
• 510(k) deficiency letters: the issues a Pre-Sub can prevent.
• Selecting a predicate device: a common Pre-Sub topic.
• US FDA medical device regulations: classification, pathways and QMSR.

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