FDA Assisted Approval

The Food and Drug Administration (FDA) has encouraged the use of engineering simulation to accelerate product development since 2012, especially in the approval stage, without compromising product reliability and safety. Recently, the organization released a format to report computer model and simulation (CM&S) results in an FDA-friendly format. 

It is still essential for medical organizations to perform clinical testing, but simulation provides great help in identifying worst-case scenarios (which could then be clinically validated if appropriate patients are included). This can eventually reduce the long, costly clinical testing while increasing product reliability. For example, medical devices can be virtually tested using a large database of virtual patients. 

An exemplary process includes developing protocols for virtual testing then clinically validating them before reporting data to the FDA for specific product applications. Once the protocol is validated and systematically applied for similar products and models, the approval process is accelerated. ANSYS works closely with the FDA to further facilitate and accelerate this process.


FDA Assisted Approval