Acting Senior Advisor for Medical Device
US Food & Drug Administration / CBER
Katherine Kim, MPH, RAC is the acting Senior Advisor for Medical Devices in the FDA’s Center for Biologics Evaluation & Research (CBER), Office of Regulatory Operations. In this role, she is the principal lead in the management and leadership of regulatory activities for CBER’s medical device program, including the evaluation of regulatory policies, implementation of regulatory initiatives, and providing regulatory guidance to CBER offices to ensure consistency and high-quality review of device submissions across the Center. She currently serves as Co-Chairs of 3 key Center Committees aimed to harmonize CBER’s device review processes and policies with those of the Center for Devices and Radiological Health (CDRH), where possible.
Prior to joining CBER, Katherine began her FDA career at the Center for Devices and Radiological Health (CDRH) in 2011 as a premarket lead scientific reviewer, bioresearch monitoring (BIMO) reviewer, and policy analyst. During her time at CDRH, she successfully led high-performance groups responsible for timely premarket review of medical devices, quality monitoring of clinical trials, and improving diversity of clinical data. Prior to joining FDA, she specialized in clinical data management and patient recruitment and retention at the National Institutes of Health (NIH) and Georgetown University. Katherine has a Bachelor of Science in Biomedical Engineering from Washington University in St. Louis and a Masters in Public Health from University of Maryland. She currently holds a Regulatory Affairs Certification (RAC) and a Project Management Certification from Duke University.
Disclosure information not submitted.
Monday, September 12, 2022
3:30 PM – 4:30 PM MST
Tuesday, September 13, 2022
2:00 PM – 3:00 PM MST