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Computational fluid dynamics (CFD) methods are increasingly being used in the development and evaluation of blood-contacting medical devices, such as prosthetic heart valves, blood pumps, and oxygenators. CFD is already being used to determine flow patterns and fluid forces in these devices. But there are as yet no standardized methods available for using CFD techniques to assess performance and safety of the final medical device designs. CDRH is launching a project to establish such methods The ultimate goal will be development of guidance on proper validation of CFD models in the assessment of medical devices.
For more information on the project and how you can join this effort, go to http://www.fda.gov/cdrh/cfd/index.html.