Please find the session links next to their corresponding agenda item.
Tuesday, November 16
12:00 PM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI
Enter this session: https://fdli.zoom.us/j/85867063095
12:05 – 1:05 PM
Overview of Medical Device Law and Regulation and Organizational Structures
Justine E. Lenehan, Associate, Kleinfeld, Kaplan, & Becker, LLP
Enter this session: https://fdli.zoom.us/j/85867063095
1:05 – 1:15 PM
Break
1:15 – 2:30 PM
Premarket Notification 510(k) and De Novo Requests
Ryan M. Fournier, Partner, Wiley
Enter this session: https://fdli.zoom.us/j/81124372746
2:30 – 2:40 PM
Break
2:40 – 3:40 PM
Registration and Listing
Abeba Habtemariam, Counsel, Arnold & Porter LLP
Enter this session: https://fdli.zoom.us/j/89157672337
3:40 – 3:50 PM
Break
3:50 – 5:00 PM
Clinical Investigations: Investigational Device Exemption (IDE), Institutional Review Boards (IRBs), and informed Consent
Blake E. Wilson, Senior Associate, Hogan Lovells US LLP
Enter this session: https://fdli.zoom.us/j/89668088844