Why Attend

Agenda

Location & CLE

subject to change
All times listed are in Eastern Time

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

 

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