Before assuming this role in 2017, Katherine Serrano served nine years in the Office of In Vitro Diagnostics and Radiological Health in Food and Drug Administration’s Center for Devices and Radiological Health’s Office of In Vitro Diagnostics and Radiological Health (CDRH). She began her FDA career as part of the 2008 inaugural class of FDA fellows and has worked as a scientific reviewer and served as the Diabetes Diagnostic Devices Branch Chief and the Deputy Director of FDA’s Division of Chemistry and Toxicology Devices. While at CDRH, Katie served as the technical and policy lead for the Agency’s efforts related to Laboratory Developed Tests.

Before working at the FDA, Serrano held positions as a regulatory affairs professional for Boston Scientific Corporation and as a biomedical engineer at the United States National Institutes of Health. Serrano received a Bachelor of Science degree in biomedical engineering and a Bachelor of Arts degree in Spanish from the University of Minnesota.