Ian M.Pearson

Associate

(T) 1.415.875.5791

Ian Pearson 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.

Experience

  • Arsenal Capital Partners acquires HistoGeneX and Caprion BiosciencesJones Day advised Arsenal Capital Partners on major investments in HistoGeneX and Caprion Biosciences and the subsequent combination of the two businesses.
  • Misonix to acquire Solys Medical, LLCJones Day is advising Misonix, Inc. in its acquisition of Solsys Medical, LLC, a privately held regenerative medical company, in an all-stock transaction valued at approximately $97 million.
  • Koch Disruptive Technologies leads $150 million investment in INSIGHTECJones Day advised Koch Disruptive Technologies, a subsidiary of Koch Industries focused on finding and funding innovative and emerging companies, as the lead investor in a $150 million Series E funding round for INSIGHTEC, a commercial stage medical device company.
  • Speaking Engagements

    • October 10, 2018DIA Combination Products Conference: Short Course - How the MDR will Affect Combination Products
    • September 26, 2018ABA Life Science Legal Summit
    • February 2018FDLI/CDRH In-House Training Course: Introduction to US Medical Device Law and Regulation
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