FDA recognizes: Simulation essential to evaluate medical devices

Computer simulation is increasingly being viewed as an important tool by medical device companies and designers for evaluating medical devices in the US. This is the reason why the US Food and Drug Administration's Center for Device and Radiological Health (CDRH) is seeing a growing number of submissions for medical devices that include a simulation-data component. The CDRH is responsible for regulating companies that manufacture, repackage, re-label, and import medical devices sold in the country. Submissions for these therapeutic devices contain data from four types of evaluation models, such as animal, bench, computational, and human, which demonstrate a reasonable assurance of safety and effectiveness. A medical device company can help in promoting approval by demonstrating both the integrity of the proposed device and the required realistic device failure analysis when it submits simulation metrics that supplement bench testing.