Post

Live Case Presentations During Investigational Device Clinical Trials

This guidance provides recommendations for IRBs, industry, clinical investigators, and FDA staff regarding live case presentations during IDE clinical trials. A live case presentation is defined as a live or pre-recorded broadcast of a surgical or percutaneous procedure, typically narrated by the operator or discussant, with potential expert panel/audience interaction. The guidance aims to ensure adequate human subject protection, follow-up, reporting, and data analysis for live case presentations.

  1. Evaluate if live case presentations are appropriate for your clinical investigation early in development
  2. Include comprehensive risk analysis addressing all additional risks in IDE application
  3. Develop specific informed consent documents for live case presentations
  4. Implement measures to minimize risks:
    • Use separate discussant/narrator
    • Record procedures when possible
    • Select appropriate subjects
    • Ensure proper sterile environment
  5. Establish data collection and reporting procedures:
    • Separate analysis of live case subjects
    • Detailed documentation of any protocol deviations
    • Comprehensive adverse event reporting
  6. Submit IDE supplement at least 30 days prior to planned presentation
  7. Obtain both FDA and IRB approval before conducting live case presentations
  8. Include live case presentation outcomes in annual progress reports and final study report
  9. Consider impact on study design and statistical analysis plan
  10. Implement additional safeguards if children are involved

Key Considerations

Clinical testing

  • Live case presentations should be conducted only at approved investigational sites by investigators participating in the study
  • Clinical outcomes should be analyzed separately and compared to the remaining investigational cohort
  • Additional follow-up may be warranted for live case subjects
  • Data collection should be no less rigorous than for the general investigational cohort

Human Factors

  • A discussant/narrator other than the operating surgeon should participate to reduce risks
  • Increased pressure on operator due to public scrutiny should be considered
  • Potential distraction of medical personnel should be addressed

Labelling

  • Informed consent must include specific information about the live case presentation
  • Additional risks and privacy concerns must be clearly described
  • No additional direct benefits should be claimed

Safety

  • Risk analysis must address increased infection risks due to additional personnel/equipment
  • Prolonged procedure time risks must be evaluated
  • Additional risks for children must be carefully considered
  • Safety measures to minimize risks must be implemented

Other considerations

  • 21 CFR part 50: Protection of Human Subjects
  • 21 CFR part 56: Institutional Review Boards
  • 21 CFR part 812: Investigational Device Exemptions

Original guidance

  • Live Case Presentations During Investigational Device Clinical Trials
  • HTML / PDF
  • Issue date: 2019-07-11
  • Last changed date: 2024-04-11
  • Status: FINAL
  • Official FDA topics: Medical Devices, Pediatric Product Development, Good Clinical Practice (GCP), Premarket, Investigational Device Exemption (IDE)
  • ReguVirta summary file ID: 2147a0ca2f860e256370b56d3e1dd6b0
This post is licensed under CC BY 4.0 by the author.