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Assessing the Credibility of Computational Modeling and Simulation in Device Submissions (FDA, Nov 2023)
FDA
Assessing the Credibility of Computational Modeling and Simulation in Device Submissions (FDA, Nov 2023)
FDA guidance on showing that computational models used as evidence in a submission are credible.
November 1, 2023
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FDA
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FDA
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https://cdn.prod.website-files.com/5f10960649ee0832d2b92042/690c3d2cea047a5a7de2aaa1_FDA%20Guidance_Computational-Modeling-Guidance.pdf
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