Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
This guidance outlines the Q-Submission (Q-Sub) Program, which provides manufacturers with opportunities to obtain FDA feedback on potential or planned medical device submissions through various types of interactions including Pre-Submissions, Submission Issue Requests, Study Risk Determinations, and Informational Meetings. The guidance covers submission processes, timelines, and best practices for engaging with FDA during device development and review.
Recommended Actions
- Submit Pre-Submissions early in development process to obtain timely feedback
- Limit Pre-Submissions to 3-4 substantial topics to ensure focused discussions
- Include clear device descriptions and specific questions requiring FDA feedback
- Submit meeting minutes within 15 days of Q-Sub meetings
- Reference previous Q-Sub interactions in subsequent submissions
- Consider timing of submissions to align with development milestones
- Maintain documentation of FDA feedback and agreements
- Submit amendments for any significant changes to contact information
- Provide presentation materials at least 2 days before scheduled meetings
- 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
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
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 summary file ID: 7d9885ed8dd231f0d097b32c01ece020
This post is licensed under CC BY 4.0 by the author.