Post

Early Collaboration Meetings for Medical Device Development: Determination and Agreement Procedures

This guidance outlines the procedures for two types of early collaboration meetings between FDA and medical device companies under FDAMA: 1. Determination Meetings: To determine the type of scientific evidence needed to demonstrate device effectiveness 2. Agreement Meetings: To reach agreement on key parameters of investigational plans for Class III devices and implants The meetings aim to provide clear direction early in device development and establish binding commitments between FDA and applicants regarding testing requirements.

  1. Contact appropriate FDA branch for initial discussion before requesting formal meeting
  2. Submit formal meeting request with required documentation:
    • Detailed device description
    • Proposed conditions of use
    • Evaluation plan
    • Available performance data
    • Clinical protocol (for Agreement Meetings)
  3. Arrange preliminary meeting to:
    • Review submitted information
    • Identify key issues
    • Determine if additional information is needed
  4. Ensure decision-makers attend formal meeting
  5. Document meeting outcomes:
    • Draft minutes within 7 days
    • Exchange with FDA for review
    • Complete evaluation checklist
  6. Monitor compliance with agreements and notify FDA of any significant changes that could void agreements
  7. Consider using informal pre-IDE meetings before formal binding meetings when dealing with novel technologies

Key Considerations

Clinical testing

  • FDA must determine if clinical studies are needed to establish effectiveness
  • Must consider least burdensome way of evaluating device effectiveness
  • Agreement on clinical protocol parameters including:
    • Sample size and statistical justification
    • Inclusion/exclusion criteria
    • Primary and secondary endpoints
    • Study success criteria
    • Study duration
    • Number of sites

Non-clinical testing

  • Pre-clinical testing may be considered in lieu of clinical data
  • Previously collected non-US data, literature, and registry data may be acceptable

Safety

  • Risk analysis must be included in proposed clinical evaluation plan
  • Data Monitoring Committee operations may need to be specified
  • Special informed consent provisions may be required

Other considerations

  • 21 CFR 812.25: Requirements for investigational plans

Original guidance

  • Early Collaboration Meetings for Medical Device Development: Determination and Agreement Procedures
  • HTML / PDF
  • Issue date: 2001-02-27
  • Last changed date: 2023-08-10
  • Status: FINAL
  • Official FDA topics: Medical Devices, Investigational Device Exemption (IDE), Premarket
  • ReguVirta summary file ID: 0cb0494612efcde51a6af791cc3f6b62
This post is licensed under CC BY 4.0 by the author.