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The U.S. Food and Drug Administration (FDA) will host a webinar to share information and answer questions about the Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions final guidance.
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Date: January 11, 2024
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Time: 1:00 to 2:00 p.m. ET
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Registration: No registration required. View webinar details for call-in information
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 computational modeling and simulation credibility.
- Answer questions about the final guidance.
Questions?
If you have questions about the webinar, contact the Division of Industry and Consumer Education.
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