Computational Modeling for Regulatory Science at FDA

BMES Medical Devices Special Interest Group Webinar: Computational Modeling for Regulatory Science in the Office of Science and Engineering Laboratories at the FDA. This webinar will give Biomedical Engineering Society Medical Devices SIG members a high-level overview of the Agency’s research around advancing knowledge on the complex interactions between electromagnetic fields and human body. These projects are conducted with active collaborations with several researchers both within the FDA and worldwide at leading academic research institutes and industry organizations. These projects have direct impact to the regulatory mission of the Agency, because anatomically precise numerical models are used by industry in pre-market evaluation of safety and effectiveness of their medical devices. The accuracy of these models and the validation methods are often fundamental issues in the ongoing regulatory evaluation.