Fundamentals of Digital Health Regulation: Successfully Navigating Your Product Through FDA

Recorded January 30, 2024 | On-Demand Materials

Tuesday, January 30

Welcome and Course Overview
Khara L. Minter, Assistant Director, Training Programs, FDLI

I.  Is My Digital Health Product a Medical Device Regulated by FDA?
Laura Bailis, Senior Counsel, Regulatory Law, Johnson & Johnson

Watch this session: https://fdli.vids.io/videos/ea90d4b01f13eac263/fdli-fundamentals-of-digital-health-day-1-session-1-is-my-digital-health-product-a-medical-device-regulated-by-fda

II.  What Regulatory Pathway Applies to My Digital Health Product? What Are Other Relevant Considerations in Digital Health?
Kelliann H. Payne, Partner, Hogan Lovells US LLP

Watch this session: https://fdli.vids.io/videos/ac90d4b01f13e9c725/fdli-fundamentals-of-digital-health-day-1-session-2-what-regulatory-pathway-applies-to-my-digital-health-product-what-are-other-relevant-considerations-in-digital-health

III.  What Post-Marketing Issues Should I Be Considering?
Christine P. Bump, Principal, Penn Avenue Law & Policy

Watch this session: https://fdli.vids.io/videos/ac90d4b01f13e8c625/fdli-fundamentals-of-digital-health-day-1-session-3-what-post-marketing-issues-should-i-be-considering

IV.  What Advertising and Promotion Requirements Apply? 
Bradley Merrill Thompson, Partner, Epstein Becker & Green, PC

Watch this session: https://fdli.vids.io/videos/0690d4b01f13e8c48f/fdli-fundamentals-of-digital-health-day-1-session-4-what-advertising-and-promotion-requirements-apply