Post

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.

  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

  • 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.