Live Case Presentations During Investigational Device Clinical Trials

What You Need to Know? 👇

What are the key requirements for conducting live case presentations during IDE clinical trials?

Live case presentations require prior FDA and IRB approval for significant risk devices. Sponsors must submit detailed risk analyses, informed consent documents, and justifications. The presentations should only be conducted at approved investigational sites by qualified investigators who have signed agreements with the sponsor.

How do live case presentations affect patient safety and what additional risks should be considered?

Live case presentations may increase risks including prolonged procedure time, operator distraction, infection from additional personnel/equipment, privacy invasion, and inadvertent broadcasting of patient identifiers. A comprehensive risk analysis must address these concerns and describe mitigation strategies to minimize patient exposure.

What specific informed consent requirements apply to live case presentations in medical device studies?

Informed consent must clearly state that participation is optional with no additional direct benefits beyond the clinical investigation. It should describe all additional risks, privacy concerns, recording/broadcasting details, and potential effects on clinical outcomes compared to non-participating subjects.

When should sponsors submit requests for live case presentations to FDA?

Requests should ideally be included in the original IDE application when anticipated. If not initially planned, supplements must be submitted at least 30 days prior to the planned presentation. Early consideration is recommended as live cases may affect overall study design and analysis.

Are live case presentations appropriate for pediatric medical device studies?

The Agency believes live case presentations involving children should only occur in rare instances. Additional IRB review is required with particular concern for safety. The added risks must present no more than minimal risk, and appropriate assent/permission procedures must be followed per 21 CFR part 50, subpart D.

How should data from live case presentations be analyzed and reported in IDE studies?

Data should be collected according to the approved investigational plan and reported separately from the main cohort. Clinical outcomes should be analyzed separately and summarized descriptively unless statistically valid comparisons can be made. Results must be included in progress reports and marketing submissions.

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What You Need to Do 👇

Recommended Actions

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

• Live case presentations are not appropriate for Expanded Access use
• Selection bias must be addressed in study design
• Impact on study blinding must be considered
• Proper reporting of adverse events during live cases is required
• Privacy and confidentiality measures must be implemented

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Relevant Guidances 🔗

• Clinical Investigation of Nocturnal Home Hemodialysis Delivery Systems
• IDE Clinical Investigation Decision Process and Requirements
• Benefit-Risk Factors in IDE Applications for Medical Device Clinical Investigations

Related references and norms 📂

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

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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 ID: 2147a0ca2f860e256370b56d3e1dd6b0