Fundamentals of Digital Health Regulation: Successfully Navigating Your Product Through FDA
February 25, 2025 | Virtual Course
Agenda
Agenda Subject to Change
All Times Listed in Eastern Time
Tuesday, February 25
11:00–11:05 AM
Welcome and Course Overview
Khara L. Minter, Assistant Director, Training Programs, FDLI
11:05 AM–12:00 PM
I. Is My Digital Health Product a Medical Device Regulated by FDA?
12:00–12:15 PM
Break
12:15–1:15 PM
II. What Regulatory Pathway Applies to My Digital Health Product? What Ae Other Relevant Considerations in Digital Health?
1:15–1:45 PM
Break
1:45–2:45 PM
III. What Post-Marketing Issues Should I Be Considering?
2:45–3:00 PM
Break
3:00–3:45 PM
IV. What Advertising and Promotion Requirements Apply?
3:45 PM
Adjournment