subject to change
All times are in Eastern Time

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

12:00–1:30 PM
Clinical Investigations
Justine E. Lenehan, Associate, Kleinfeld, Kaplan & Becker, LLP

1:30–1:40 PM

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

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

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

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

1:40–2:40 PM
Enforcement and Compliance
Brandon J. Moss, Partner, Wiley LLP

2:40–2:50 PM

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

4:00–5:00 PM
International Issues
Sarah H. Stec, Senior Counsel, Medical Device Regulatory Law, Johnson & Johnson

5:00 PM