Sousan S. Sheldon, Ph.D. is a former FDA Primary Reviewer, Supervisory Reviewer, Scientific Policy Advisor, and International Policy Analyst in the FDA’s Commissioners’ Office for medical devices and pharmaceuticals with expertise in various FDA Centers including CDER, CDRH, CBER, and CFSAN. She is an expert in regulatory pathways for INDs, NDAs, ANDAs, 510(k)s, IDEs, De Novo, HDE, PMAs, and other regulatory submissions and has extensive knowledge in the development of medical devices, medical devices containing antimicrobial agents, combination products, companion diagnostic products, and applications for Clinical Laboratory Improvement Amendment waivers. Dr. Sheldon has participated as an expert witness in various litigation cases related to medical devices and pharmaceuticals. She has a doctoral degree in Clinical Microbiology/ Clinical Immunology from the University of North Texas and a postdoctoral degree in public health clinical labs from the Virginia Commonwealth University. She has also practiced as a Medical Technologist in clinical laboratories in various states from 1982 to 2019.