CDRH Workshop on Computational Modeling Practices

CDRH has announced a 4/13-15 public workshop entitled “Towards Good Simulation Practices in Health Technologies” that will discuss modeling and simulation practices currently used in health technologies by the device industry. “The key topics to be discussed are the role of computational modeling and simulation in the regulatory evaluation of health technologies and current simulation practices, with the goal of gathering input to inform the development of good simulation practice recommendations,” according to a Center notice.

CDRH says that computational modeling is a priority and it has become an important tool for evaluating medical devices, and complementing bench, in vivo and clinical methods. “The Office of Science and Engineering Laboratories of CDRH has committed significant resources to transform computational modeling from a valuable scientific tool to a valuable regulatory tool and to develop mechanisms to rely more on digital evidence,” the notice says.