Preconference Primers
Preconference Primer (Virtual) (60 Minutes)
Overview of Medical Device Law and Regulation and Organizational Structures
McKenzie Cato, Associate, Hyman, Phelps & McNamara, PC
Preconference Primer (Virtual) (45 Minutes)
Combination Products
James A. Boiani, Partner, Epstein Becker & Green, PC
Megan Robertson, Associate, Epstein Becker & Green, PC
Wednesday, November 16
11:00 AM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI
11:05–11:50 AM
Digital Health
Allison Fulton, Partner, Sheppard Mullin Richter & Hampton LLP
11:50 AM–12:00 PM
Break
12:00–1:30 PM
Clinical Investigations
Anisa Mohanty, Counsel, McDermott Will & Emory
1:30–1:40 PM
Break
1:40–2:55 PM
Premarket Notification 510(k) and De Novo Requests
Sarah Rys, Sr. Principal Regulatory Affairs Specialist, Medtronic
2:55–3:05 PM
Break
3:05–4:20 PM
Premarket Approval Application (PMA); Humanitarian Device Exemption (HDE); Breakthrough Devices
Deborah Baker-Janis, Senior Director, NSF International
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)
Cybil Roehrenbeck, Partner, Hogan Lovells US LLP
Thursday, November 17
11:00 AM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI
11:05 AM–12:20 PM
Post Marketing Issues
Véronique Li, Senior Medical Device Regulation Expert, Hyman Phelps & McNamara, PC
12:20–12:30 PM
Break
12:30–1:30 PM
Manufacturing and Quality System (QS) Regulation
Janet Book, Senior Consultant, NSF International
1:30–1:40 PM
Break
1:40–2:40 PM
Enforcement and Compliance
Scott D. Danzis, Partner, Covington & Burling LLP
Amy Leiser, Associate, Covington & Burling LLP
2:40–2:50 PM
Break
2:50–3:50 PM
Promotion and Advertising
Scott D. Danzis, Partner, Covington & Burling LLP
Amy Leiser, Associate, Covington & Burling LLP
3:50–4:00 PM
Break
4:00–5:00 PM
International Issues
Kristin M. Kaplan, Senior Counsel, Shook, Hardy & Bacon LLP
5:00 PM
Adjournment
