Kenneth Phillips PhD U.S. FDA

CDR Kenneth Phillips is currently Lab Chief for the Laboratory of Analytical Chemistry in FDA/CBER Office of Compliance and Biologics Quality. He earned his PhD in Analytical Chemistry (biosensors) at the University of California, and his postdoc was in biomedical engineering (single cell analysis) at UNC Chapel Hill. He was previously a lead reviewer in FDA/CDRH, where he led research for 13 years on infections associated with medical devices. CDR Phillips is an expert consultant on preclinical performance testing of antimicrobial medical devices and their mechanisms of action. He developed the first performance testing strategy rubric for antimicrobial device testing (Nature Reviews Biomedical Engineering 2023), pioneered the concept of "Medical Devices on Chips" (Nature Biomedical Engineering 2017), and has published research on microbial interactions and test methods for numerous medical device types. He was the PI of a 3-hospital industry-FDA-healthcare collaborative study on the cleanliness of endoscopes at the point of reprocessing (manuscript in preparation). He has supervised over 29 students and postdocs at FDA, published over 50 scholarly works, organized an industry workshop on Medical Device Biofilms, provided over 350 consults to FDA reviewers, and remains active in FDA guidance and ISO standards development for antimicrobial devices.