Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program

What You Need to Know? 👇

What is the Q-Submission Program and how can it benefit my medical device development?

The Q-Submission Program is FDA’s structured process for obtaining feedback before submitting formal applications. It includes Pre-Submissions, Study Risk Determinations, and other interaction types that can improve submission quality, shorten review times, and facilitate device development through early FDA engagement.

When should I submit a Pre-Submission versus other Q-Sub types?

Submit a Pre-Submission when seeking FDA feedback on specific questions about planned IDE, marketing submissions, or clinical studies before execution. Use Submission Issue Requests for addressing hold letters, Study Risk Determinations for clinical study risk classification, and Informational Meetings for sharing information without expecting feedback.

What are the key timelines for Q-Submission reviews under MDUFA V?

Pre-Submissions receive written feedback within 70 days, with meetings scheduled between days 70-75. Submission Issue Requests get 21-day responses if submitted within 60 days of FDA letters, otherwise 70 days. Study Risk Determinations take 90 days, and Informational Meetings are scheduled within 90 days.

How should I structure my Pre-Submission questions for maximum effectiveness?

Focus on 3-4 substantial topics with specific, targeted questions that include proposed approaches and rationales. Avoid asking FDA to design studies or requesting pre-review of data. Include sufficient background information and clearly state your planned follow-on submission type to enable focused FDA feedback.

What happens to FDA feedback if I make changes to my device or study design?

FDA feedback remains valid if your future submission is consistent with Pre-Sub information and no new safety/effectiveness issues emerge. FDA may modify feedback only when new scientific findings, public health concerns, or significant device changes materially affect regulatory decisions, with appropriate management concurrence.

Are there interactions with FDA that don’t require a Q-Submission?

Yes, administrative questions, simple review clarifications, interactive review during active submissions, appeal meetings, 513(g) classification requests, Emergency Use Authorizations, and requests for Medical Device Development Tools fall outside the Q-Submission Program and use alternative pathways.

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What You Need to Do 👇

Recommended Actions

1. Submit Pre-Submissions early in development process to obtain timely feedback
2. Limit Pre-Submissions to 3-4 substantial topics to ensure focused discussions
3. Include clear device descriptions and specific questions requiring FDA feedback
4. Submit meeting minutes within 15 days of Q-Sub meetings
5. Reference previous Q-Sub interactions in subsequent submissions
6. Consider timing of submissions to align with development milestones
7. Maintain documentation of FDA feedback and agreements
8. Submit amendments for any significant changes to contact information
9. Provide presentation materials at least 2 days before scheduled meetings
10. Follow up within 1 year if significant time passes between feedback and implementation

Key Considerations

Clinical testing

• Clinical study protocols should be submitted with specific questions and rationale rather than requesting FDA to design studies
• For OUS studies intended to support marketing applications, consider submitting full protocol through Pre-Sub process
• Clinical study feedback is most valuable when requested prior to study initiation
• If more than 1 year has passed since previous FDA feedback on study design, confirm validity of previous advice

Non-clinical testing

• Provide specific proposals with rationale for non-clinical testing approaches
• Include justification for worst-case testing scenarios
• Consider timing of feedback requests to inform test protocol development
• Reference applicable standards and guidance documents in testing proposals

Human Factors

• Submit human factors test protocols for FDA feedback
• Include use-related risk analysis plans
• Provide participant recruitment plans for validation testing
• Identify critical tasks for evaluation

Software

• Specify software level of concern classification
• Address validation of emerging technologies
• Document software architecture and requirements
• Reference previous software documentation if applicable

Cybersecurity

• Identify attack vectors
• Submit cybersecurity management plans
• Propose risk models for security assessment
• Define appropriate security controls based on device risk

Biocompatibility

• Justify test article selection for worst-case scenarios
• Propose chemical characterization approaches
• Provide rationale for omitting specific biocompatibility tests
• Consider alternative test methods when appropriate

Labeling

• Submit test plans to support specific labeling claims
• Address reprocessing validation for reusable devices
• Include protocols for shelf-life testing
• Provide MRI compatibility testing plans if applicable

Safety

• Address sterilization validation approaches
• Include cleaning and disinfection protocols
• Provide shelf-life testing proposals
• Consider risk mitigation strategies

Other considerations

• Clearly identify device description and intended use
• Reference previous FDA interactions and submissions
• Consider combination product requirements if applicable
• Address predetermined change control plans if relevant

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Relevant Guidances 🔗

• Q-Submission Program for Medical Device Manufacturer Feedback and FDA Meetings (Draft)

Related references and norms 📂

• ISO 11135-2014: Sterilization of health-care products - Ethylene oxide
• ISO 14971: Medical devices - Application of risk management to medical devices
• IEC 62304: Medical device software - Software life cycle processes
• ISO 10993 series: Biological evaluation of medical devices

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Original guidance

• Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
• HTML / PDF
• Issue date: 2023-06-02
• Last changed date: 2023-08-10
• Status: FINAL
• Official FDA topics: Medical Devices, Investigational Device Exemption (IDE), Administrative / Procedural, Biologics
• ReguVirta ID: 7d9885ed8dd231f0d097b32c01ece020