Dr. Om V. Singh is the Principal of Lucida Scientific and Regulatory Consulting, LLC, and a seasoned regulatory consultant with extensive experience at the U.S. Food and Drug Administration (FDA) and in industry. He previously served as an Interdisciplinary Scientist and Lead Reviewer at the FDA, where he evaluated 510(k), PMA, and IND submissions and reviewed medical devices for safety, efficacy, sterilization, and reprocessing compliance. Dr. Singh is deeply familiar with FDA regulatory frameworks, standards, and guidelines, including GMP and QSR requirements. In industry, he has led regulatory consulting projects supporting 510(k) and De Novo submissions, coordinated FDA–industry meetings for scientific data review, and advised on strategies to demonstrate substantial equivalence and streamline clearance pathways. His expertise spans FDA approvals, biocompatibility, and risk management, with a proven track record helping companies bring medical devices and antimicrobial products to market efficiently and in compliance with regulatory expectations.