{"id":605342,"date":"2024-06-01T06:00:04","date_gmt":"2024-06-01T10:00:04","guid":{"rendered":"https:\/\/platohealth.ai\/fda-guidance-on-computational-modeling-and-simulation-in-medical-device-submissions\/"},"modified":"2024-06-04T05:00:40","modified_gmt":"2024-06-04T09:00:40","slug":"fda-guidance-on-computational-modeling-and-simulation-in-medical-device-submissions","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/fda-guidance-on-computational-modeling-and-simulation-in-medical-device-submissions\/","title":{"rendered":"FDA Guidance on Computational Modeling and Simulation in Medical Device Submissions","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"
Computational modeling is the use of computers to simulate and study complex systems using mathematics, physics, and computer science. Simulation is achieved by adjusting the variables independently, or in combination with each other, and observing the outcomes. A StarFish Medical whitepaper, Computational Modeling and Simulation (CM&S) in Medical Devices<\/a>, provides a broad overview of CM&S and its usefulness in the medical device industry.<\/p>\n CM&S can greatly improve the product development lifecycle by providing a cheaper and faster pathway to arrive at the final product design. Medical Device companies can also execute and collect evidence of device safety and performance without the need to develop multiple Proofs of Concepts (POCs) for assessment.<\/p>\n FDA has issued a few guidances and reports around CM&S, identifying that computational modeling and simulation studies can be used to add value to bench testing and nonclinical in vivo and clinical studies used to evaluate the safety and effectiveness of medical devices.<\/p>\n FDA Guidance Document \u201c<\/em>Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions<\/em><\/a>\u201d <\/em>provides a general risk-informed framework to assess the CM&S during regulatory submissions. The guidance is heavily based on the FDA recognized standard ASME V&V 40 Assessing Credibility of Computational Modeling through Verification and Validation: Application to Medical Devices, <\/em>a standard that identifies a framework for assessing verification, validation, and uncertainty quantification (VVUQ).<\/p>\n The guidance provides a nine-step process for developing and assessing the credibility of CM&S for regulatory submissions.<\/p>\n Define how the model will be used and perform a risk assessment.<\/strong><\/p>\n The first three steps of the framework involve defining the way the computational model will be used and the risk of using the model.<\/p>\n Prospective Planning <\/strong><\/p>\n The next three steps in the guidance document revolve around planning for execution of the model and identifying evidence that may be required for regulatory submissions. These steps are critical to identify if additional input is required, and companies would benefit from FDA feedback through the Q-Submission Program. FDA Guidance \u201c<\/em>Requests for Feedback and Medical Device Submissions: The Q-Submission Program (June 2023)<\/em><\/a>\u201d <\/em>provides additional information on the Q-Submission program.<\/p>\n The guidance provides eight categories of credibility evidence that can characterize the evidence to support a computational model. The eight categories and their definitions are provided in Figure 2.<\/p>\n\n
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Figure 1: Example of model risk assessment combined with model influence and decision consequence in a 3\u00d73 grid. Source: <\/em>StarFish Medical<\/em><\/a><\/p>\n
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