Day 1

Day 2
Resources

Please find the session links next to their corresponding agenda item.

Prerecorded

Overview of Medical Device Law and Regulation and Organizational Structures
Kristin M. Zielinski Duggan, Partner, Hogan Lovells US LLP

Watch this session here.

Combination Products
Alan G. Minsk, Partner, Arnall Golden Gregory LLP
Laura S. Dona, Associate, Arnall Golden Gregory LLP

Watch this session here.

 

Wednesday, April 13

11:00 AM 

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

Enter this session: https://fdli.zoom.us/j/86321668158

11:05 – 11:50 AM 

Digital Health
Kyle Y. Faget, Partner, Foley & Lardner LLP

Enter this session: https://fdli.zoom.us/j/86321668158

11:50 AM – 12:00 PM 

Break

12:00 – 1:30 PM 

Clinical Investigations
Samantha Hong, Associate, Kleinfeld, Kaplan & Becker, LLP

Enter this session: https://fdli.zoom.us/j/86863681225

1:30 – 1:40 PM

Break

1:40 – 2:55 PM

Premarket Notification 510(k) and De Novo Requests
Maura Martin Norden, Executive Vice President, Medical Products & Combination Products, Greenleaf Health, Inc.
Heather S. Rosecrans, Executive Vice President, Medical Products & Combination Products, Greenleaf Health, Inc.

Enter this session: https://fdli.zoom.us/j/83217067233

2:55 – 3:05 PM

Break

3:05 – 4:20 PM

Premarket Approval Application (PMA); Humanitarian Device Exemption (HDE); Breakthrough Devices
Quynh Hoang, Senior Regulatory Consultant, King & Spalding LLP

Enter this session: https://fdli.zoom.us/j/89272824825

4:20 – 4:30 PM

Break

4:30 – 5:30 PM

Coverage, Coding and Payment – Collaboration Between FDA and the Centers for Medicare and Medicaid Services (CMS)
Preeya Noronha Pinto, Partner, King & Spalding LLP

Enter this session: https://fdli.zoom.us/j/84769389505

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