FDA Pre-Submission (Q-Submission) Guide: How to Get FDA Feedback Before Your Medical Device Submission

What Is the Q-Submission Program?

The FDA's Q-Submission (Q-Sub) Program provides medical device manufacturers with formal mechanisms to request feedback and meetings with FDA review staff before, during, and after the premarket review process. It is the primary channel for structured, documented communication between device sponsors and the FDA outside of a formal submission.

The program was established in 1995 as the Pre-IDE (Investigational Device Exemption) Program for IDE-related interactions. It was expanded significantly under the FDA Safety and Innovation Act (FDASIA) of 2012 and rebranded as the Q-Submission Program. The most recent final guidance, "Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program", was issued in May 2025.

Key benefit: A well-prepared Pre-Submission can reduce the risk of 510(k) or PMA rejection, accelerate your time to market, and save hundreds of thousands of dollars in avoidable study costs. There is no user fee for Pre-Submissions.

The May 29, 2025 final guidance supersedes the June 2023 version and introduces several key changes: FDA now recommends a maximum of four primary topics per Pre-Submission, informal feedback via email or phone is explicitly acknowledged for simple questions, and a companion draft guidance for an eSTAR template specifically for Q-Submissions was also issued on the same date.

Types of Q-Submissions

The Q-Submission Program encompasses several distinct interaction types:

1. Pre-Submission (Pre-Sub)

The most common and valuable type. A Pre-Sub allows you to request FDA feedback on your device, proposed regulatory pathway, study design, or testing strategy before you submit a 510(k), De Novo, PMA, or IDE.

• FDA provides formal written feedback
• You may also request a meeting (teleconference or in-person) to discuss the feedback
• No user fee
• Typically limited to 3-5 focused questions per submission

2. Submission Issue Request (SIR)

Used when your 510(k), De Novo, or PMA is under review and has been placed on hold or you have received Additional Information (AI) letters. A SIR allows you to discuss specific issues with the FDA before submitting a formal response.

• Can request a meeting or written feedback
• No user fee
• Useful for clarifying FDA expectations before resubmitting

3. Informational Meeting

A meeting to provide the FDA with general information about your device, technology, or company without requesting specific feedback. Useful for:

• Introducing novel technologies to the FDA

• Providing updates on long-term development programs

• Discussing general regulatory strategy without posing specific questions

• No formal written feedback from FDA (though informal discussion occurs)

• No user fee

4. PMA Day 100 Meeting

For PMA applicants, a meeting held approximately 100 days after PMA submission to discuss the status of the review, any deficiencies identified, and the path forward.

• Required by statute for original PMA applications
• Automatically scheduled by the FDA

5. Agreement and Determination Meetings

Available for PMA and HDE (Humanitarian Device Exemption) applicants:

• Agreement meeting — Discusses the plan for collecting data to support the PMA (Section 513(a)(3)(D))
• Determination meeting — Discusses the FDA's determination on the valid scientific evidence needed to demonstrate reasonable assurance of safety and effectiveness

6. Breakthrough Device Meetings

For devices granted Breakthrough Device Designation (BDD), additional Q-Submission meeting types are available:

• Sprint discussions — Focused, rapid-cycle interactions
• Priority review coordination
• Senior FDA management involvement

7. Study Risk Determinations

Used to request the FDA's determination on whether a clinical study presents a significant or nonsignificant risk (SR/NSR).

Q-Submission Types Summary

Type	Purpose	Feedback	Meeting	Fee
Pre-Sub	Feedback before submission	Written + optional meeting	Optional	None
SIR	Resolve submission issues	Written or meeting	Optional	None
Informational Meeting	Share information	None (discussion only)	Yes	None
PMA Day 100	Review status update	Discussion	Yes	None
Agreement/Determination	Data collection plan	Written	Yes	None
Breakthrough Device	Expedited interaction	Written + meetings	Yes	None
Study Risk	SR/NSR determination	Written	No	None

Why Use Pre-Submissions

Risk Reduction

The primary value of a Pre-Sub is reducing regulatory risk. Common scenarios where Pre-Subs are invaluable:

• Novel device with unclear classification — Get FDA agreement on the regulatory pathway before investing in testing
• Unclear equivalence — Discuss whether your device is substantially equivalent to a predicate before filing a 510(k)
• Complex clinical study design — Get FDA input on study endpoints, sample size, and statistical methods before enrolling patients
• Software and AI/ML devices — Discuss validation approaches, clinical study needs, and predetermined change control plans
• Combination products — Clarify the lead center and regulatory expectations

Time and Cost Savings

• Avoid conducting studies that the FDA ultimately deems insufficient
• Reduce the number of FDA review cycles for your submission
• Identify potential regulatory barriers early in development, when pivoting is less expensive

When to Submit a Pre-Submission

Optimal Timing

The best time for a Pre-Sub depends on the questions you need answered:

• Early development (concept phase) — For pathway determination and classification questions
• Mid-development (design phase) — For study design, testing requirements, and validation approach
• Late development (pre-submission phase) — For confirming that your submission package is complete and well-organized

When NOT to Submit

• When your questions are purely about FDA process or policy (use the FDA's public guidance documents or the CDRH ombudsman instead)
• When you are not yet ready to discuss specific details about your device
• When you have more than 5-6 questions (schedule additional meetings instead)

What to Include in a Pre-Submission Package

A complete Pre-Submission package should include:

Cover Letter

• Company name and contact information
• Device trade name and classification (if known)
• Proposed regulatory pathway (510(k), De Novo, PMA, IDE)
• Type of feedback requested (written only, or written + meeting)
• List of specific questions for the FDA

Device Description

• Detailed description of the device, its intended use, and the indication(s)
• How the device works (principles of operation)
• Comparison to predicate devices (for 510(k) pathway)
• Key technological characteristics
• If applicable, comparison to previously cleared devices

Proposed Regulatory Pathway

• 510(k), De Novo, PMA, or other pathway
• Justification for the chosen pathway
• Identification of the product code and regulation number (if known)

Specific Questions

This is the most important part. Each question should be:

• Focused — One specific topic per question
• Contextualized — Provide sufficient background for FDA to understand why you are asking
• Actionable — Frame the question so the FDA can provide a clear response
• Numbered — For easy reference in written feedback and during meetings

Examples of good questions:

• "Based on the proposed bench testing protocol described in Attachment 1, will the FDA accept these test methods and acceptance criteria to demonstrate substantial equivalence for [device] under 510(k)?"
• "For our proposed clinical study design (see protocol summary in Attachment 2), are the proposed primary endpoint, sample size justification, and statistical analysis plan acceptable to the FDA?"
• "Given the proposed indication for use [specific text], does the FDA agree that a 510(k) is the appropriate regulatory pathway, or is a De Novo classification request warranted?"

Preliminary Data (If Available)

• Bench test data
• Animal study results
• Prior clinical data
• Software validation results
• Any data that supports the proposed approach or answers

Proposed Meeting Agenda (If Meeting Requested)

• Topics to be discussed
• Estimated time per topic
• List of attendees from the sponsor

How to Submit

Electronic Submission

Q-Submissions are submitted electronically through the FDA's submission system:

• eSTAR — The preferred electronic submission template
• eCopy — Electronic copy on CD/DVD or via the FDA's electronic gateway

The submission should follow the format described in the Q-Submission guidance, with clearly labeled sections and attachments.

Submission Tracking

Each Q-Sub is assigned a unique Q-Sub number (e.g., Q240001). This number is used for all subsequent correspondence and meeting scheduling.

FDA Review Timeline

Standard Timeline

The FDA targets the following timelines for Q-Submissions:

Interaction Type	Target Timeline
Pre-Sub written feedback	70-90 calendar days from receipt
Pre-Sub meeting (after written feedback)	Within 75 days of accepting the meeting request
SIR	60-75 calendar days
Study Risk Determination	30 calendar days
Informational Meeting	75 calendar days

What Happens During Review

1. Receipt and acceptance — FDA confirms the submission is complete and assigns a Q-Sub number
2. Lead reviewer assigned — A lead reviewer from the appropriate review division is assigned
3. Review and feedback preparation — The review team evaluates your questions and prepares written feedback
4. Written feedback issued — Typically provided 3-5 days before a scheduled meeting
5. Meeting held (if requested) — Discussion of the written feedback and any additional questions
6. Meeting minutes — The sponsor drafts minutes, which are submitted for FDA review and agreement

Meeting Preparation

Team Preparation

• Designate a single point of contact for all FDA communications
• Ensure all meeting attendees understand their roles
• Prepare a concise slide deck (if appropriate) that walks through each question
• Have subject matter experts ready for each topic area

Presentation Structure

A typical Pre-Sub meeting lasts 60 minutes. Structure your time carefully:

1. Introduction and background (5-10 minutes) — Company, device, and meeting objectives
2. Question-by-question discussion (40-45 minutes) — Address each question, present your approach, discuss FDA's written feedback
3. Summary and next steps (5 minutes) — Confirm action items and clarify any outstanding issues

Tips for Productive Meetings

• Start with your most critical questions — If time runs short, the important items will have been addressed
• Listen more than you talk — The goal is to understand the FDA's perspective, not to convince them
• Ask clarifying questions — If FDA feedback is unclear, ask for clarification during the meeting
• Do not present new data — The meeting is to discuss the information already provided in the Q-Sub
• Take detailed notes — You will draft the meeting minutes

Post-Meeting: Meeting Minutes

After the meeting, the sponsor drafts meeting minutes and submits them to the FDA for review. This is a critical step:

• Minutes should accurately reflect the discussion, including areas of agreement and disagreement
• The FDA reviews and either agrees with or suggests modifications to the minutes
• Agreed-upon minutes become part of the official record
• The minutes serve as your reference for what the FDA expects in your eventual submission

Pre-Submissions for Specific Pathways

For 510(k) Submissions

Pre-Subs are most commonly used for 510(k) devices when:

• The predicate device is not clearly identified
• The technological characteristics differ from the predicate
• Clinical data may be needed to support substantial equivalence
• The classification is uncertain

For De Novo Classification

Pre-Subs are highly recommended for De Novo requests because:

• The device has no predicate, making classification uncertain
• The FDA's expectations for evidence are case-specific
• A meeting can clarify the level of evidence needed

For PMA Applications

Pre-Subs for PMA devices typically address:

• Clinical study design (endpoints, sample size, controls)
• Whether an Advisory Panel meeting is expected
• Post-approval study requirements
• Modular PMA strategy

For Breakthrough Devices

If your device has been granted Breakthrough Device Designation:

• Sprint discussions provide rapid, iterative feedback
• Senior FDA managers participate in key meetings
• Pre-Subs should be used to discuss the overall development plan, not individual questions in isolation

For Software and AI/ML Devices

Pre-Subs for software devices should address:

• Clinical validation approach for SaMD
• Software validation and verification strategy (IEC 62304)
• Cybersecurity risk management
• For AI/ML: Predetermined Change Control Plan (PCCP) if applicable
• Real-world evidence generation strategy

Common Mistakes

1. Too many questions — More than 5-6 questions dilutes the discussion and reduces the quality of feedback. Schedule additional meetings if needed.

2. Vague questions — "What do you think of our device?" is not actionable. Ask specific, focused questions with proposed answers for FDA to comment on.

3. Insufficient data — Submitting a Pre-Sub without supporting data makes it difficult for the FDA to provide meaningful feedback. Include whatever preliminary data you have.

4. Not following FDA feedback — If the FDA tells you during a Pre-Sub that a certain approach is insufficient, do not ignore that feedback in your eventual submission.

5. Waiting too long — Submitting a Pre-Sub when the device is already fully developed and tested reduces its value. Engage early when you can still adjust your development plan.

6. Over-relying on Pre-Sub feedback — Pre-Sub feedback is not binding. The FDA can change its position when reviewing the actual submission, especially if new information emerges.

7. Poor meeting preparation — Wasting meeting time on background that was already in the written submission, instead of discussing the key feedback points.

Best Practices

1. Submit early — A Pre-Sub is most valuable when you can still change your development plan
2. Be specific — Propose your approach and ask the FDA to comment, rather than asking open-ended questions
3. Limit questions to 3-5 — Focus on the most critical regulatory decisions
4. Include preliminary data — Even partial data helps the FDA provide more specific feedback
5. Request written feedback first — Get the FDA's written response before the meeting so you can prepare focused discussion points
6. Document everything — Keep thorough records of all Q-Sub correspondence, feedback, and meeting minutes
7. Follow up on feedback — If the FDA suggests a different approach, document how you addressed their feedback in your eventual submission

Frequently Asked Questions

Is there a fee for Pre-Submissions?

No. There is no user fee for any type of Q-Submission, including Pre-Submissions.

How long does it take to get FDA feedback on a Pre-Sub?

The FDA targets 70-90 calendar days for written feedback on Pre-Submissions.

Is FDA Pre-Sub feedback binding?

No. Pre-Sub feedback represents the FDA's current thinking based on the information provided. It is not a guarantee of approval. The FDA can change its position when reviewing the actual submission.

Can we submit a Pre-Sub for any device?

Yes. Any medical device manufacturer can submit a Pre-Sub, regardless of device classification or regulatory pathway.

How is a Pre-Sub different from a 510(k)?

A Pre-Sub is a request for feedback — it is not a marketing submission. You cannot market a device based on Pre-Sub feedback. You still need to submit a 510(k), De Novo, or PMA.

Can we have multiple Pre-Subs for the same device?

Yes. Many companies submit multiple Pre-Subs at different stages of development. Each Pre-Sub should address a distinct set of questions.

What happens if we disagree with FDA feedback?

You can discuss your concerns during the meeting and provide additional data or arguments to support your position. If the disagreement persists, document your rationale in your eventual submission. You may also request additional meetings.

Do we need a Pre-Sub for every device?

No. Many straightforward 510(k) submissions do not require a Pre-Sub. Pre-Subs are most valuable for novel devices, unclear regulatory pathways, or complex clinical study designs.

Can a foreign manufacturer submit a Pre-Sub?

Yes. Any sponsor, including foreign manufacturers, can submit a Pre-Sub. The process is the same regardless of the company's location.

What is the difference between a Pre-Sub and an informal communication?

Informal communications (emails, phone calls with FDA staff) do not create an official record. A Pre-Sub provides formal, documented feedback that becomes part of the regulatory file. For important strategic decisions, always use the formal Q-Submission process.

Can we submit a Pre-Sub for an IDE?

Yes. In fact, the Pre-Submission program was originally designed for IDE-related questions. Clinical study design questions are among the most common Pre-Sub topics.

What if our device qualifies for Breakthrough Device Designation?

If your device has BDD status, you have access to additional interaction types (sprint discussions, senior management involvement). You should still use the Pre-Sub framework to structure your interactions, but expect more frequent and rapid FDA engagement.

Related Guides

• 510(k) Submission Guide — Complete walkthrough of the 510(k) process from predicate selection to FDA clearance.
• FDA Breakthrough Device Designation Guide — Eligibility, benefits, and application process for the Breakthrough Device Program.
• FDA De Novo Classification Guide — The pathway for novel low-to-moderate risk devices without a predicate.
• Medical Device Clinical Trials & IDE Guide — Planning and executing clinical studies under an Investigational Device Exemption.
• AI/ML Medical Device Regulatory Guide — Regulatory frameworks for AI/ML-based medical devices, including PCCP considerations.