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Is Your App a Drug, a Device, or Something Else Entirely?
Session Chair(s)
Ernest S. Voyard, JD
Associate Director, Global Regulatory Policy and Intelligence
Janssen Research & Development, LLC, United States
This forum will present and examine FDA’s regulation of “apps” and discuss what is required to bring these types of digital health technologies to market. A panel of experts will discuss their experience working with the FDA in this evolving area.
Learning Objective : Discuss FDA’s current landscape regarding the regulation of mobile digital health solutions (or “apps); Describe best practices when working with the agency to bring such solutions to market; Explain how to differentiate between those products that may be considered a device, a drug, or a “digital therapeutic”.
Speaker(s)
FDA Perspective
Kristina Lauritsen, PHD
FDA, United States
Combination Products Regulatory Policy Advisor, OEP, CDER
Industry Perspective
Yuri Maricich, MD, MBA
Pear Therapeutics, United States
Chief Medical Officer and Head of Development
Industry Perspective
Vernessa Pollard, JD
McDermott Will & Emery LLP, United States
Partner, Chair FDA Pratice