Last Year’s Agenda

subject to change

All times listed are in Eastern Time

2022 Curriculum Advisor:
Scott Danzis, Partner, Covington & Burling LLP

 

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