Preconference Primer
Preconference Primer (Virtual) (60 Minutes)
Overview of Medical Device Law and Regulation and Organizational Structures
Kristin M. Zielinski Duggan, Partner, Hogan Lovells US LLP
Preconference Primer (Virtual) (45 Minutes)
Combination Products
Alan G. Minsk, Partner, Arnall Golden Gregory LLP
Wednesday, April 13, 2022
11:00 AM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI
11:05–11:50 AM
Digital Health
Kyle Y. Faget, Partner, Foley & Lardner LLP
11:50 AM–12:00 PM
Break
12:00–1:30 PM
Clinical Investigations
Samantha Hong, Associate, Kleinfeld, Kaplan & Becker, LLP
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.
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
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
Thursday, April 14, 2022
11:00 AM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI
11:05 AM–12:20 PM
Post Marketing Issues
Allyson B. Mullen, Director, Hyman, Phelps & McNamara, PC
12:20–12:30 PM
Break
12:30–1:30 PM
Manufacturing and Quality System (QS) Regulation
Dennis C. Gucciardo, Partner, Morgan, Lewis & Bockius LLP
1:30–1:40 PM
Break
1:40–2:40 PM
Enforcement and Compliance
Brandon J. Moss, Partner, Wiley LLP
2:40–2:50 PM
Break
2:50–3:50 PM
Promotion and Advertising
Scott D. Danzis, Partner, Covington & Burling LLP
3:50–4:00 PM
Break
4:00–5:00 PM
International Issues
Sarah H. Stec, Senior Counsel, Johnson & Johnson
5:00 PM
Adjournment