FDA Offers Framework For Assessing Credibility Of Devices Designed With Computational Modeling And Simulation

The US FDA has issued draft guidance to help manufacturers substantiate the credibility of computational modeling and simulation used in submitting their medical devices to the agency for premarket approval. The agency says deficiencies in analytical methods for evaluating CM&S hampers its use in supporting regulatory submissions.

Medical device manufacturers often rely on computational modeling and simulation (CM&S) when designing new products. CM&S technology allows engineers and designers to conduct countless simulated experiments on virtual subjects.

During these experiments, numerous variables can be introduced into a programmed computation, then adjusted to observe various outcomes. These simulations...