Preconference Primers
Preconference Primer (Virtual) (60 Minutes)
Overview of Medical Device Law and Regulation and Organizational Structures
McKenzie E. Cato, Associate, Hyman, Phelps & McNamara, P.C.
Preconference Primer (Virtual) (45 Minutes)
Combination Products
James A. Boiani, Member of the Firm, Epstein Becker & Green, PC
Megan Robertson, Associate, Epstein Becker & Green, PC
Wednesday, October 11
11:00 AM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI
11:05–11:50 AM
Digital Health
Bethany J. Hills, Partner, DLA Piper LLP (US)
11:50 AM–12:00 PM
Break
12:00–1:30 PM
Clinical Investigations
Justine E. Lenehan, Associate, Kleinfeld, Kaplan & Becker, LLP
1:30–1:40 PM
Break
1:40–2:55 PM
Premarket Notification 510(k) and De Novo Requests
Kristin R. Davenport, Partner, Covington & Burling LLP
Olivia Dworkin, Associate, Covington & Burling LLP
2:55–3:05 PM
Break
3:05–4:20 PM
Premarket Approval Application (PMA); Humanitarian Device Exemption (HDE); Breakthrough Devices
Lina R. Kontos, Partner, Hogan Lovells US 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)
Michael M. Gaba, Shareholder, Polsinelli PC
Thursday, October 12
11:00 AM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI
11:05 AM–12:20 PM
Post Marketing Issues
Lauren Farruggia, Associate, Goodwin Procter LLP
12:20–12:30 PM
Break
12:30–1:30 PM
Manufacturing and Quality System (QS) Regulation
Janet Book, Principal Program Lead Medical Devices, NSF International
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
Carolina M. Wirth, Of Counsel, Hall, Render, Killian, Health & Lyman P.C.
3:50–4:00 PM
Break
4:00–5:00 PM
International Issues
Sarah H. Stec, Senior Counsel, Medical Device Regulatory Law, Johnson & Johnson
5:00 PM
Adjournment