What Is an FDA Pre-Sub (Q-Sub)? Complete Q-submission 2025 Guide
- Beng Ee Lim
- Jul 2
- 7 min read
Updated: 3 days ago
An FDA Q-Submission (Q-Sub) is a voluntary program allowing medical device companies to request feedback and meetings with FDA before or during formal premarket submissions. Q-Subs help align regulatory strategy, reduce submission deficiencies, and accelerate approval timelines through early FDA engagement.
Quick Answer: Q-Subs include Pre-Submissions for early feedback, Agreement Meetings for complex protocols, and various specialized meeting types. The May 2025 updated guidance strongly encourages eSTAR electronic format and limits Pre-Submissions to 4 topic areas maximum.
The strategic Q-Sub decision can save or cost you 6 months. This guide covers when to request Q-Subs, application requirements, and how to maximize FDA feedback value for regulatory success.
What Is an FDA Q-Submission?
The Q-Submission Program is FDA's voluntary mechanism for companies to request feedback, meetings, and guidance on medical device submissions before filing formal applications.
Established to improve submission quality and reduce review times, Q-Subs allow sponsors to align with FDA expectations early in development, potentially avoiding costly late-stage changes and submission deficiencies.
Core Q-Sub Benefits
Risk Reduction: Early FDA feedback prevents submission deficiencies and reduces regulatory uncertainty throughout development.
Timeline Acceleration: Aligned development strategy eliminates review cycles and resubmission delays.
Resource Optimization: Focused feedback helps prioritize testing and evidence collection efforts.
Strategic Clarity: Direct FDA input on pathway selection, study design, and evidence requirements.
2025 Program Updates
The May 29, 2025 update guidance significantly expanded Q-Sub scope and clarified when formal submissions aren't necessary:
Informational Inquiries Clarified: Routine, process-only questions may be handled by email or phone without a formal Q-Sub.
eSTAR for Pre-Subs: FDA encourages using the eSTAR interactive PDF, but it is not (yet) mandatory. Mandatory eSTAR begins 1 Oct 2025 for most marketing submissions, not for Pre-Subs.
Topic-limit for Pre-Subs: FDA recommends limiting each Pre-Submission to no more than four primary topics so reviewers can provide focused feedback.
Meeting-type Descriptions Refined: No new categories were added; the draft simply sharpens definitions of existing types.
Types of Q-Submissions: Choosing Your Engagement Strategy
Pre-Submission (Pre-Sub)
Most common Q-Sub type for early regulatory strategy alignment.
Purpose: Obtain FDA feedback on planned submissions, testing strategies, clinical protocols, or regulatory pathways before formal application.
Best For:
Novel devices without clear regulatory precedent
Complex testing or clinical study design questions
Pathway selection guidance (510(k) vs. De Novo vs. PMA)
Predicate device selection and substantial equivalence strategy
Specialized Q-Sub for IDE-related questions.
Purpose: Obtain FDA determination whether planned clinical study qualifies as significant risk, nonsignificant risk, or exempt from IDE regulations.
Critical Value: Incorrect risk determination can shut down clinical studies or trigger FDA enforcement actions.
Submission Issue Meeting
Problem-solving Q-Sub during active FDA review.
Purpose: Address specific technical or regulatory issues identified during FDA review of pending submissions.
Strategic Use: Resolve review deficiencies faster than traditional amendment cycles.
Agreement Meeting
High-stakes Q-Sub for complex development programs.
Purpose: Reach formal agreements with FDA on protocols, endpoints, or regulatory strategies for complex devices.
When Needed: High-risk devices, novel endpoints, or situations requiring FDA commitment to specific review approaches.
Determination Meeting
Specialized Q-Sub for classification and pathway questions.
Purpose: Obtain FDA determination on device classification, regulatory pathway, or specific regulatory requirements.
Day 100 Meeting
Mid-review checkpoint for PMA applications.
Purpose: Discuss FDA's initial review findings and address questions that could affect final approval decision.
Strategic Value: Course-correct before final review completion to avoid approval delays.
When to Request Q-Sub: Strategic Decision Framework
High-Value Q-Sub Scenarios
Novel Device Technology When your device represents new technology without clear regulatory precedent, Q-Sub provides pathway clarity and evidence requirements.
Complex Study Design For clinical studies with novel endpoints, unique patient populations, or innovative trial designs requiring FDA input.
Regulatory Pathway Uncertainty When 510(k) vs. De Novo vs. PMA pathway isn't clear, or when predicate device selection is challenging.
Predicate Device Strategy For 510(k) submissions where substantial equivalence argument needs FDA input or predicate selection requires validation.
High-Risk Development Programs When development investment is significant and regulatory failure would be catastrophic to business.
When to Skip Q-Sub
Straightforward 510(k) with Clear Predicate When substantial equivalence is obvious and testing requirements are well-established.
Simple Questions with Clear Guidance When FDA guidance documents clearly address your questions or regulatory requirements.
Minimal Development Risk When submission failure wouldn't significantly impact business or development timeline.
Resource Constraints When 3-4 month Q-Sub timeline would delay critical business milestones.
The 2025 Informal Communication Option
FDA's updated guidance allows informal communication for questions that:
Can be answered based on reviewer's existing knowledge
Don't require additional context or in-depth review
Don't need multiple FDA staff involvement
Have clear answers in existing guidance documents
Examples of informal communication topics:
Whether specific testing mentioned in guidance documents applies
Clarification of guidance document requirements
Simple classification or pathway questions
Q-Sub Application Requirements: What FDA Needs
Pre-Submission Package Components
1. Cover Letter and Administrative Information
Clear identification of Q-Sub type, device description, and specific meeting request with preferred dates.
2. Device Description
Comprehensive technical overview including mechanism of action, intended use, technological characteristics, and key device features.
3. Regulatory Background
Previous FDA interactions, applicable guidance documents, predicate device analysis (for 510(k) pathway), and regulatory history.
4. Specific Questions
Well-defined questions organized by topic area with sufficient background context for meaningful FDA response.
5. Supporting Documentation
Relevant test data, clinical information, literature references, and any materials necessary for FDA to provide informed feedback.
2025 eSTAR Requirements
FDA recommends using eSTAR for Pre-Subs.
Pre-STAR Template Features:
Integrated databases for FDA product codes and consensus standards
Targeted questions for specific data collection
Maximum of 4 topic areas per submission
Standardized format improving review efficiency
Submission Preparation: eSTAR guides submitters through comprehensive preparation with built-in databases and auto-fill capabilities.
Question Strategy for Maximum Value
Specific Over General: "What testing is required for our specific device indication?" vs. "What testing do you recommend?"
Context-Rich Background: Provide sufficient technical detail for informed FDA response without overwhelming with unnecessary information.
Prioritized Topic Areas: Focus on highest-impact questions given 4-topic limit in new Pre-STAR template.
Decision-Focused Queries: Frame questions around specific decisions you need to make rather than requesting general guidance.
Q-Sub Timeline and Process Management
Standard Q-Sub Timeline
Submission to FDA Response:
Pre-Submission (written feedback): 70 days
Pre-Submission (meeting): 75-90 days including meeting
Study Risk Determination: 60 days
Other Q-Sub types: Varies by complexity
Optimizing Q-Sub Timing
Early Development Stage: Best for pathway guidance and major strategic decisions before significant resource investment.
Pre-Clinical Completion: Ideal timing when preliminary data exists but clinical protocols need refinement.
Pre-Submission Filing: Final opportunity to align before formal submission preparation begins.
Avoid Late-Stage Q-Subs: When development is nearly complete, Q-Sub feedback may come too late to implement meaningfully.
Managing FDA Feedback
Meeting Preparation: Prepare follow-up questions based on anticipated FDA responses and bring technical experts who can address detailed questions.
Documentation: Maintain detailed records of all FDA feedback and how it influenced development decisions.
Implementation Planning: Develop clear action items from FDA feedback with timelines and resource requirements.
Follow-Up Strategy: Plan additional Q-Subs if feedback raises new questions or if significant development changes occur.
Maximizing Q-Sub ROI: Best Practices
Pre-Submission Preparation
Internal Alignment: Ensure development team agrees on key questions and acceptable FDA responses before submission.
Regulatory Research: Review relevant guidance documents, predicate devices, and FDA precedents before requesting feedback.
Question Prioritization: Focus on decisions that significantly impact development timeline, cost, or submission strategy.
Expert Consultation: Consider regulatory consultant input for complex devices or first-time Q-Sub submissions.
During FDA Interactions
Active Participation: Bring technical experts who can engage in detailed scientific discussions with FDA reviewers.
Clarification Requests: Ask follow-up questions during meetings to ensure clear understanding of FDA feedback.
Documentation: Take detailed notes and request clarification of any ambiguous feedback.
Relationship Building: Establish professional relationships with FDA team members for future interactions.
Post-Q-Sub Implementation
Rapid Implementation: Address FDA feedback quickly while reviewer insights are fresh and team memory is clear.
Change Documentation: Maintain clear records linking development decisions to FDA feedback for future submissions.
Team Communication: Ensure all development team members understand FDA feedback implications for their work.
Strategic Adjustment: Use FDA feedback to refine overall regulatory strategy and subsequent Q-Sub planning.
Common Q-Sub Mistakes and Solutions
Premature Q-Sub Submission
Problem: Requesting feedback before sufficient development progress to ask informed questions.
Solution: Wait until specific decisions need FDA input rather than seeking general guidance.
Overly Broad Questions
Problem: Asking general questions that receive generic responses with limited actionable value.
Solution: Frame questions around specific decisions with adequate technical context.
Poor Follow-Up
Problem: Failing to implement FDA feedback or maintain engagement with review team. Solution: Develop clear implementation plans and maintain periodic communication with FDA.
Inadequate Meeting Preparation
Problem: Attending meetings without technical experts or sufficient background research. Solution: Bring appropriate technical team members and prepare for detailed scientific discussions.
Multiple Q-Sub Confusion
Problem: Requesting multiple Q-Subs without clear strategic purpose or proper sequencing. Solution: Develop comprehensive Q-Sub strategy aligned with development milestones and submission planning.
Your Strategic Q-Sub Decision
The Q-Submission program represents one of FDA's most valuable tools for regulatory success, but only when used strategically. Companies that master Q-Sub timing and execution gain significant competitive advantages through aligned development strategies and reduced regulatory risk.
The key isn't whether to use Q-Subs—it's knowing when Q-Sub investment provides maximum return.
Smart companies use Q-Subs for high-impact decisions while handling routine questions through informal communication or existing guidance.
For complex or novel devices, Q-Sub engagement often determines the difference between regulatory success and expensive failure. Early FDA alignment prevents late-stage surprises that can derail even the most promising innovations.
Action Steps:
Assess your Q-Sub need using our decision framework
Identify critical questions requiring FDA input for development decisions
Plan Q-Sub timing to maximize feedback implementation value
Prepare comprehensive submissions using current eSTAR requirements
Your regulatory strategy determines whether FDA accelerates or delays your path to market. Use Q-Subs strategically, and FDA becomes your development partner rather than regulatory hurdle.
Ready to optimize your FDA engagement strategy?
Complizen's AI-powered regulatory platform helps identify optimal Q-Sub timing and develops winning submissions that maximize FDA feedback value for faster regulatory success.
Frequently Asked Questions
How long should I wait for FDA Q-Sub response?
FDA typically responds within 70 days for written feedback and 75-90 days for meetings. However, response times can vary based on FDA workload, question complexity, and seasonal factors affecting reviewer availability.
Can I request multiple Q-Subs for the same device?
Yes, multiple Q-Subs are common for complex devices. However, each should address different development stages or distinct questions. Avoid redundant submissions that could frustrate FDA reviewers.
What if FDA feedback contradicts my development strategy?
FDA feedback isn't binding, but ignoring it significantly increases submission risk. Consider requesting follow-up meetings to discuss alternative approaches or seek additional clarification before proceeding.
Should I hire a consultant for Q-Sub preparation?
For complex devices, novel technologies, or first-time Q-Sub submissions, regulatory consulting often provides valuable expertise. However, straightforward questions may not justify consulting costs.
How does Q-Sub feedback affect my submission review?
While Q-Sub feedback doesn't guarantee submission approval, following FDA guidance significantly reduces deficiency risk. FDA reviewers often reference previous Q-Sub interactions during formal review.
