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Monday, June 15 • 1:30pm - 2:30pm
#123 L: Is Your App a Drug, a Device, or Something Else Entirely?

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-540-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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”.


Ernest S. Voyard, JR, JD


FDA Perspective
Kristina Lauritsen, PhD

Industry Perspective
Yuri Maricich, MD, MBA

Industry Perspective
Vernessa Pollard, JD

avatar for Ernest Voyard

Ernest Voyard

Associate Director, Global Regulatory Policy and Intelligence, Janssen Research & Development, LLC
Ernest is an associate director of Regulatory Policy and Intelligence for The Janssen Pharmaceutical Companies of Johnson and Johnson. There he focuses on public policy issues related to the development of drugs and biologic products. Ernest has spent most of his career working on... Read More →
avatar for Yuri Maricich

Yuri Maricich

Chief Medical Officer and Head of Development, Pear Therapeutics
Dr. Maricich leads the Clinical/Regulatory/Quality group at Pear Therapeutics as the Chief Medical Officer and Head of Development. He leads and manages the development programs from Discovery/TPP stage, thru Translational, Clinical Development, Regulatory submission and review as... Read More →
avatar for Vernessa Pollard

Vernessa Pollard

Partner, Chair FDA Pratice, McDermott Will & Emery LLP
Vernessa T. Pollard provides strategic business and regulatory advice to FDA-regulated companies on complex issues related to the development, manufacture, marketing, post-market safety and compliance for FDA-regulated products, including medical devices and digital health technology... Read More →

Kristina Lauritsen

Combination Products Regulatory Policy Advisor, OEP, CDER, FDA
Kristina Lauritsen, PhD serves as a Combination Product Policy Advisor within the Center for Drug Evaluation and Research (CDER) at the FDA. In this role, she is responsible for engaging in development of CDER's policies related to combination product review and regulation, including... Read More →

Monday June 15, 2020 1:30pm - 2:30pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Session