Tina Morrison is the Director of the Office of Regulatory Science and Innovation in the Office of the Chief Scientist at the FDA.
She joined the FDA in 2008 through the Medical Device Fellowship Program. For the first 7 years, Tina was a regulatory reviewer of cardiovascular devices, where she participated in several initiatives as part of CDRH’s Innovation Pathway: early feasibility studies program, streamlining clinical trials, the medical device development tools program, and the Medical Device Innovation Consortium.
Alongside the regulatory review work, she was also worked to advance the role of computer modeling and simulation in medical device design and product evaluation. She founded and chaired two working groups: the Regulatory Review of Computational Modeling working group for CDRH, and the Modeling and Simulation working group for FDA.
Tina led the development of guidance and standards for enhancing modeling credibility and acceptance. She led the development a verification and validation standard for ASME, which culminated in 2018 with the first-ever set of evaluating procedures for computational modeling of medical devices, the ASME V&V 40 standard.
Because of these efforts, Tina was FDA’s Federal Engineer of the Year in 2019, received ASME’s Dedicated Service Award in 2020, and she was inducted into the University of Connecticut’s Academy of Distinguished Engineers.