Edgar J. Asebey, Esq. is a seasoned FDA regulatory counsel with over 15 years of experience guiding biotech, medical device, and pharmaceutical companies through the intricacies of FDA compliance, market entry, and product development. As a partner at Keller Asebey Life Science Law, PLLC, Edgar has played a pivotal role in fast-tracking regulatory approval for AI-driven diagnostics, in vitro diagnostics, and cutting-edge medical devices. He is an expert in navigating 510(k) clearances, PMA submissions, GMP audits, and compliance issues such as FDA warning letters and import alerts. Edgar’s strategic guidance has been vital in helping biotech companies, particularly those leveraging AI in diagnostics, meet regulatory requirements while accelerating their path to commercialization. His extensive knowledge of global regulatory frameworks and deep expertise in FDA, FTC, and CMS compliance makes him an invaluable asset in ensuring both innovation and regulatory success for biotech ventures.