Tina M. Morrison PhD

Dr. Morrison is the Chair of the FDA Modeling and Simulation Working Group, sponsored by the Office of the Chief Scientist, which launched in the Fall of 2016. She has been serving as the Regulatory Advisor of Computational Modeling for the Office of Device Evaluation since 2011. In that capacity, she leads the Regulatory Review of Computational Modeling working group at CDRH, which has developed guidance documents on the use of modeling and simulation in the regulatory evaluation of medical devices. She dedicates much of her energy towards advancing regulatory science through modeling and simulation because she believes the future of medical product design and evaluation, and thus enhanced patient care, lies with computation and enhanced visualization. Her contributions to advance modeling and simulation at FDA were honored with the 2019 Federal Engineer of the Year for FDA award.

Tina also serves as Chair of the ASME Committee on Verification and Validation (V&V) of Computational Modeling, as well as the subcommittee (V&V 40) on Computational Modeling of Medical Devices, where she is leading the development of a strategy to assess the credibility of computational models. The standard was published in November 2018, culminating 6 years of work with 40 industry parterners. She is working with a team at CDRH to implement this strategy into the review of premarket submissions that leverage computational modeling. For seven years, she was a scientific reviewer on a variety of medical device premarket submissions in Cardiovascular Devices.

Dr. Morrison is a mechanical engineer who studied Cardiovascular Biomechanics as a post-doctoral fellow at Stanford University. During that time, she investigated the in vivo biomechanics of the aorta using gated CT imaging; those data are now used as boundary conditions for modeling and bench-testing of devices in FDA submissions. She received her PhD in Theoretical and Applied Mechanics from Cornell University in 2006.