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As per the available reports about 10 Journals, 6 Conferences and 10 National Symposium and 12 open access articles have been published on Computational Modeling. Computational modeling and simulation studies , together with bench, non-clinical in vivo, and clinical studies, are tools that can be used to evaluate the safety and effectiveness of medical devices.
Scope and Importance:
In order for the CM&S studies to provide valid scientific evidence in regulatory submission, specific details need to be included in the report of the studies. In this guidance, the term “CM&S report” refers to the part of a premarket submission that provides information about a CM&S study; the term does not describe a new submission requirement. The outline provided in this document aims to establish uniformity in reporting CM&S studies. FDA recognizes that there is a variety of CM&S modalities and specific details will vary across disciplines. Therefore, we have provided a general outline in the main body of this document and five subject matter appendices for modeling and simulation modalities that are widely used in regulatory submissions. The main body is written in general terms to capture reporting for any modality. The five appendices provide more background, structure, and specific terminology for the following subject areas: I. Fluid Dynamics and Mass Transport II. Solid Mechanics Electromagnetics and Optics III. IV. Ultrasound V. Heat Transfer For multiphysics modeling, recommendations in several of these appendices may apply. Apart from the CM&S being used to support regulatory submission, we recognize that CM&S can be part of a medical device (e.g., physiological closed-loop feedback system for ventilator), or can be the medical device (e.g., electrical source estimation software, standalone medical device intended to provide decision support). This guidance document does not address the reporting of the latter two uses of CM&S, though the overall concepts outlined in this guidance are applicable.
While verification and validation are necessary components of the report of CM&S studies, this document does not establish levels of verification and validation needed for regulatory submissions. Further, this guidance document does not address how to conduct a computational modeling or simulation study, nor does adherence to this guidance ensure that your computational modeling or simulation study is adequate or appropriate. This guidance only provides guidelines for reporting this information to FDA and highlights some common issues with models and simulations.
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According to a new market report published by Transparency Market Research titled on "Computational Biology (Pharmacodynamics, Cellular Modeling, Computational Genomics, Proteomics, Pharmacogenomics, Pharmacokinetics, Human Simulation Software, Drug Discovery & Development) - Global Industry Analysis, Size, Share, Growth, Trends and Forecast, 2012 - 2018," the global computational biology market was valued at $760 million in 2011. It is further predicted to rise at a CAGR of 21.3% from 2012 to 2018 and reach an estimated value of $2,937.3 million by 2018.
International Symposium and Workshop
·Design Modeling Symposium Copenhagen 2015 Modeling Behavior Sep 30 – Oct 2 2015, Denmark
·5th International Computational Modeling Symposium, Nov 16-19 , 2015 , Cape Town , South Africa
·Workshop on cognitive Modeling and Computational Linguistics , Colorado , USA
· Health Economics Conference,
July 25-26,2016, Berlin, Germany.
· 4th Translational Medicine Conference,
October 26-28 ,2015,Baltimore,USA.
· Biological Cell Information Processing Workshop,
31 Aug-4Sep , Auckland , New Zealand
· Computational Modeling 2015,
June 9-10 , 2015 ,Falmoth ,UK
· The International Conference Mathematical and Computational Modeling in Science and Technology,
Izmir , Turkey
· 17th International Conference on Computational Modeling and Simulation Analysis,
·Society for Computational Economics
·The computational social science society for Americans
·Society for Computational Modeling of Association Learning
·Computational Modeling for the American Chemical Society
·Royal Society Open Science
·The applied computational Electromagnetic Society
·The European Society of Computational Modeling
·International Society for Bayesian Analysis
·Society for Industrial and Applied Mathematics
·Biomedical Engineered Society
·Rhetoric Society of America
·IEEE Computational Intelligence Society
·American Society for Cellular and Computational Toxicology
·Rogers Archeology Lab
·Computational Fluid Dynamics
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This page was last updated on November 25, 2020