US FDA Center for Devices and Radiological Health

Regulatory Policy Advisor

About

Ryan Ortega is a regulatory advisor and biomedical engineer in the Office of Product Evaluation and Quality (OPEQ) at FDA’s Center for Devices and Radiological Health (CDRH). He provides regulatory policy advice and guidance to teams across the Office on multiple issues, including infection control and device sterilization. Ryan joined the Agency in 2015 as a Commissioner’s Fellow and joined the infection control team in 2017 as a lead reviewer and sterility reviewer. In that role, he helped plan and implement the Agency’s 2019 advisory committee meeting focused on medical device sterilization and he helped to implement CDRH’s sterilization innovation challenges and the ethylene oxide masterfile pilot program. During the ongoing COVID-19 public health emergency, he served as the Acting Team Lead and later the Acting Assistant Director for CDRH’s PPE, Reprocessing & Disinfection Devices Team until transitioning into his current role in July of this year. He helped develop and implement emergency use authorization strategies and immediately-in-effect policies and guidance for infection control devices during the public health emergency. He earned his B.E., M.S., and PhD in biomedical engineering from Vanderbilt University.