Ryan Ortega

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. His current work portfolio includes infection control and medical device sterility, public health emergency transition planning, and device-specific guidances and regulatory orders. Ryan represents OPEQ on CDRH’s ethylene oxide Tiger Team, a cross functional group that provides strategic planning and response to help ensure continued access to sterilize medical devices. He serves as a sterility subject matter expert on CDRH’s Sterility Specialty Task Group that oversees development and recognition of sterility standards at CDRH and is a member of CDRH's Sterility Standards Task Force. Ryan joined the Agency in 2015 as a Commissioner’s Fellow working on developing novel regulatory review practices for regenerative medicine products. He joined the CDRH infection control team as a lead reviewer in 2017. During the COVID-19 public health emergency, he served as the Acting Assistant Director for CDRH’s PPE, Reprocessing & Disinfection Devices Team until transitioning into his current role in July of 2021. He earned his PhD in biomedical engineering from Vanderbilt University.