Ian Pearson, JD focuses on FDA regulatory matters, with an emphasis on medical devices, combination products, and the evolving digital health sector. Before joining Jones Day, Ian served for more than seven years in the U.S. Food and Drug Administration's Office of Chief Counsel. During that time he was responsible for providing FDA with legal advice on a wide range of regulatory matters across multiple sectors. In recent years, Ian was an FDA lead in the area of digital health and worked on numerous issues pertaining to mobile medical applications, health information technology, clinical decision support software, and genetic testing.
At FDA, Ian also worked across product areas and was a member of the device counseling, combination products, and information disclosure teams. He has significant first-hand experience navigating the complexities of the Federal Food, Drug, and Cosmetic Act (FFDCA), as well as the Administrative Procedure Act, Freedom of Information Act (FOIA), Privacy Act, and provisions of the Public Health Service Act applicable to FDA regulatory matters.
Ian recently assisted agency officials with the development and implementation of the 21st Century Cures Act, which contains provisions clarifying FDA's authority to regulate certain types of medical software. He also helped to draft industry guidance on digital health topics and real-world evidence generation, and he worked closely with FDA senior staff on a multitude of related projects, including the development of FDA's Digital Health Software Precertification (PreCert) Pilot Program.
This speaker's sessions: