Day Three – November 7, 2024Thursday, 7 November 2024

• In planning clinical and/or marketing submissions, one pivotal decision stands at the forefront: whether or not to engage in a pre-submission with the FDA
• Comprehend the benefits and drawbacks of engaging in a pre-submission, and how it impacts the regulatory pathway for medical devices
• Learn to evaluate the potential risks and advantages of pre-submissions in the context of specific device types and regulatory objectives

• Are eSTARs mandatory for all devices?
• Shared experiences of using the eSTAR form
• Has the form enhanced the submission process and working practice efficiency?
• Are there any current pain points with using the form?
• Does the form align with other regions’ submission processes?
• Are there any upcoming proposed changes?

• Clinical data requirements – US vs EU

• Is there a difference in expectation across regions?

• How is sufficient data defined?

• Ensuring sufficient data is collected

• Can you leverage data from previous devices or other regions?

• Examples of rectifying insufficient data

• Clinical Evaluation documents – not just the CEP and CER
• Collaborating for Success with Cross-functional Partners
• Compliant, Concise, and Comprehensive Clinical Evaluation
• Continuous Improvement from Notified Body review

• Current acceptance of RWE globally

  • Is 1 region further along in acceptance than another?

  • Current pathway for using RWE in FDA and European submissions

    • Expectations of Notified Bodies and Regulators

• Case studies: suitable RWE for differing risk classes

• Future forecast for harmonization of standards

• Emphasize the importance of utilizing post-market data to inform and improve risk management processes in healthcare.
• Provide strategies for analyzing complaint trends and answering questions related to Clause 10.3 of ISO 14971:2019.
• Highlight the need for continuous feedback of post-production data into risk management to ensure continuous improvement.
• Offer a practical framework for integrating post-market insights with risk management, enhancing patient safety, and continuous improvement.

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