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
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