FDA Webinar - Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions Final Guidance

When: 11/01/2024 - 11/01/2024
Where: Online
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.
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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.

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.

Registration is not necessary.

Date: January 11, 2024

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

More info on FDA website



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