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

This guidance outlines the Q-Submission (Q-Sub) Program, which provides mechanisms for medical device manufacturers to request feedback and meetings with FDA regarding medical device submissions. It covers various types of Q-Subs including Pre-Submissions, Submission Issue Requests, Study Risk Determinations, Informational Meetings, and PMA Day 100 Meetings. The guidance aims to facilitate interactions between FDA and industry to improve the efficiency of the medical device review process.

This is a draft guidance. Not for implementation.

  1. Review applicable FDA guidance documents and standards before preparing Q-Sub
  2. Carefully plan submission timing to align with development program needs
  3. Limit scope to 3-4 substantial topics with focused questions
  4. Provide clear proposals with rationale rather than open-ended questions
  5. Include sufficient background information while avoiding extraneous content
  6. Submit meeting minutes within 15 days of any Q-Sub meeting
  7. Consider dependencies between questions when planning submissions
  8. Follow proper submission formatting and eCopy requirements
  9. Specify preferred feedback format (written and/or meeting)
  10. Track and reference previous FDA interactions in future submissions
  11. Submit new Pre-Sub if more than 1 year has passed since previous feedback
  12. Include draft agenda and multiple meeting date options when requesting meetings

Key Considerations

Clinical testing

  • Clinical study protocols should be submitted with specific questions and rationale for chosen approach
  • FDA feedback on clinical studies should be obtained prior to study initiation
  • If more than 1 year has passed since previous FDA feedback on study design, confirm if advice is still applicable
  • For OUS studies intended to support marketing applications, consider submitting full protocol for FDA feedback

Non-clinical testing

  • Provide specific proposals with rationale for non-clinical testing approaches
  • Include references to applicable guidance documents and standards
  • Consider timing of FDA feedback requests to inform testing plans
  • Clearly articulate intended outcomes and labeling claims to be supported

Human Factors

  • Submit human factors test protocols for FDA review
  • Include use-related risk analysis plans
  • Specify test participant recruitment plans
  • Identify critical tasks for evaluation

Software

  • Specify software level of concern classification
  • Document validation approach for emerging technologies
  • Address multiple function device products appropriately
  • Reference previously reviewed software documentation when applicable

Cybersecurity

  • Identify and document attack vectors
  • Provide cybersecurity management plans
  • Specify risk models for cybersecurity assessment
  • Define appropriate security controls based on device risk

Biocompatibility

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

Labeling

  • Submit test plans to support specific labeling claims
  • Address reprocessing/cleaning validation for reusable devices
  • Include protocols for MR Conditional labeling
  • Provide validation for shelf-life claims

Safety

  • Document sterilization validation approaches
  • Address reprocessing requirements
  • Validate shelf-life claims
  • Consider worst-case testing scenarios

Other considerations

  • ISO 11135-2014: Sterilization of health-care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices

Original guidance

  • Q-Submission Program for Medical Device Manufacturer Feedback and FDA Meetings
  • HTML / PDF
  • Issue date: 2024-03-15
  • Last changed date: 2024-03-14
  • Status: DRAFT
  • Official FDA topics: Medical Devices, Administrative / Procedural, Premarket, Biologics
  • ReguVirta summary file ID: e9137b1c5c4a92ffde91f42458caace8
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