Seminar for the Orthopaedic Research Society - Modeling & Simulation at CDRH

The Center for Devices and Radiological Health is committed to advancing regulatory science with computational modeling.  Specifically, there is a role for modeling and simulation in the evaluation of medical devices, from the research and development stage to supporting the approval/clearances of devices on the market.  Numerous challenges remain before we can fully realize the potential for modeling and simulation.  One of the key challenges is being able to review the computational model and evaluate the evidence available to support its use in regulatory submissions.  To overcome this challenge, FDA has recently published a guidance document for Reporting Computational Modeling Studies in Medical Device Submissions.  In this document, we outline our recommendations on the format and organization of the report.  Better reporting will improve our consistency in decision making and foster broader acceptance of modeling and simulation.  Moreover, another key challenge is know what level of evidence is needed to support using a computational model to make regulatory decisions.  On this front, FDA is working closely with industry to develop a risk-informed credibility assessment framework.  Finally, to tackle scientific and technical challenges, CDRH continues its research endeavors in modeling and simulation.  The webinar will focus on these key aspects: the guidance on reporting, the standard on credibility evidence, and scientific research projects.