Day 1

 

Day 2
Day 3
Resources

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

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