April 10, 2026
Dr Kathleen Young is a lead reviewer at the FDA’s Center for Devices and Radiological Health (CDRH). She joined the agency in CDRH/OPEQ/OHT4 in December 2022 and conducts total product life cycle reviews with a focus on wound care and plastic surgery devices. She has led the review of more than 150 pre- and postmarket submissions, including Medical Device Development Tools for wounds, and provides biocompatibility and engineering consults. She serves on cross-cutting inter-center groups to foster wound care and regenerative medicine efforts across centers, and is a liaison to the Wound Care Collaborative Community Tools Working Group.