FDA Pre-Submission Guide: Get Feedback Before a Device Submission
Guide to FDA's Q-Submission program for medical devices, including Pre-Subs, Submission Issue Requests, Information Meetings, feedback requests, content, timelines, fees, and meeting strategy.
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Pre-Submission, informal feedback via email or phone is explicitly acknowledged for simple questions, and a companion draft guidance for an eSTAR template specifically for Q-Submissions was also issued on the same date.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
Receipt and acceptance — FDA confirms the submission is complete and assigns a Q-Sub number
Lead reviewer assigned — A lead reviewer from the appropriate review division is assigned
Review and feedback preparation — The review team evaluates your questions and prepares written feedback
Written feedback issued — Typically provided 3-5 days before a scheduled meeting
Meeting held (if requested) — Discussion of the written feedback and any additional questions
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:
Introduction and background (5-10 minutes) — Company, device, and meeting objectives
Question-by-question discussion (40-45 minutes) — Address each question, present your approach, discuss FDA's written feedback
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
Too many questions — More than 5-6 questions dilutes the discussion and reduces the quality of feedback. Schedule additional meetings if needed.
Vague questions — "What do you think of our device?" is not actionable. Ask specific, focused questions with proposed answers for FDA to comment on.
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.
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.
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.
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.
Poor meeting preparation — Wasting meeting time on background that was already in the written submission, instead of discussing the key feedback points.
Best Practices
Submit early — A Pre-Sub is most valuable when you can still change your development plan
Be specific — Propose your approach and ask the FDA to comment, rather than asking open-ended questions
Limit questions to 3-5 — Focus on the most critical regulatory decisions
Include preliminary data — Even partial data helps the FDA provide more specific feedback
Request written feedback first — Get the FDA's written response before the meeting so you can prepare focused discussion points
Document everything — Keep thorough records of all Q-Sub correspondence, feedback, and meeting minutes
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.