• Summary
• Background
• Webinar Details
• Webinar Materials

Summary

On January 11, 2024, the U.S. Food and Drug Administration (FDA) will host a webinar for industry and other interested stakeholders to discuss the final guidance: Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions.

During this webinar, the FDA will:

• Discuss how manufacturers can use the guidance to show that computational models used to support regulatory submissions are credible,
• Provide recommendations for using the FDA-recognized standard American Society of Mechanical Engineers (ASME) V&V 40 Assessing Credibility of Computational Modeling through Verification and Validation: Application to Medical Devices to show CM&S credibility, and
• Answer questions about the final guidance.

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Background

Medical device manufacturers are using computational modeling and simulation (CM&S), also called in silico methods, increasingly to help streamline device development and premarket evaluation. The guidance provides a framework that manufacturers can use in their regulatory submissions to the FDA to show that computational models are credible.

Webinar Details

Registration is not necessary.

Date: January 11, 2024

Time: 1:00 PM - 2:00 PM ET

Please dial in 15 minutes before the start of the call to allow time to connect.

Please click the link below to join the webinar: https://fda.zoomgov.com/j/1609132203?pwd=bWJBc3JkR2dCNENhRmNGbTU5ZUEwUT09

Passcode: Xc=5$R

Please note: Participants who join the webinar using the Zoom webinar link above should use computer audio (listen through their computer speakers and speaking through computer microphone/headset).

The dial-in information provided below is for participants who will be joining the webinar by phone only.

• U.S. Callers Dial: 833-568-8864 (Toll Free)
  • For higher quality, dial a number based on your current location:
    • +1 669 254 5252 US (San Jose)
    • +1 646 964 1167 US (US Spanish Line)
    • +1 646 828 7666 US (New York)
    • +1 551 285 1373 US
    • +1 669 216 1590 US (San Jose)
    • +1 415 449 4000 US (US Spanish Line)
• International Caller Dial: Please check the international numbers available
• Webinar ID: 160 913 2203
• Passcode: 162533

Webinar Materials

The presentation, printable slides, and transcript will be available at CDRH Learn under the section “Specialty Technical Topics”, sub-section “Regulatory Science Tools.”

If you have questions about this guidance document or the webinar, please contact CDRH's Division of Industry and Consumer Education (DICE) at dice@fda.hhs.gov, 1-800-638-2041, or 301-796-7100.