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  4. Webinar - Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions Final Guidance - 01/11/2024
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Webcast | Virtual

Event Title
Webinar - Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions Final Guidance
January 11, 2024

Date:
January 11, 2024
Time:
1:00 p.m. - 2:00 p.m. ET

Summary

On January 11, 2024, the U.S. Food and Drug Administration (FDA) held 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:

  • Discussed how manufacturers can use the guidance to show that computational models used to support regulatory submissions are credible,
  • Provided 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
  • Answered questions about the final guidance.

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 Materials

The presentation, printable slides, and transcript are 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.

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