The U.S. Food and Drug Administration (FDA) is seeking assistance to identify vendors that can provide simulations with virtually implanted generic medical devices using a whole-heart computational model.
The request for information (RFI) says that the computational model needs to be able to adapt to represent relevant disease states to create “virtual patients,” as well as “virtual populations.” With these, the FDA “can conduct an in silico clinical trial with data that can be used to support a proposal for a real clinical trial.”
The Division of Applied Mechanics within the FDA’s Center for Devices and Radiological Health’s Office of Science and Engineering Laboratories is interested in these vendors as part of a Project Plan to harness computational modeling to reduce the size of prospective clinical trials for medical devices.
“To accomplish our goals in the Project Plan, we will need a physics-based computational model of a whole human heart, one that includes all critical functionality of the heart,” the RFI said.
Responses to the RFI are due by Aug. 12.