Introduction to Medical Device Law and Regulation
October 29–30, 2024 Virtual Course
Agenda
2024 Curriculum Advisor:
Steven S. Tjoe, Partner, Goodwin Procter LLP
All times are in Eastern Time
Preconference Primers
Preconference Primer (Virtual) (60 Minutes)
Overview of Medical Device Law and Regulation and Organizational Structures
Laura S. Dona, Associate, Arnall Golden Gregory LLP
Preconference Primer (Virtual) (45 Minutes)
Combination Products
Nicholas M. Benetatos, Principal, Exponent, Inc.
Tuesday, October 29
11:00 AM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI
11:05–11:50 AM
Digital Health
Atiq Chowdhury, Associate, Morrison Foerster
11:50 AM–12:00 PM
Break
12:00–1:30 PM
Clinical Investigations
Amy Leiser, Associate, Covington & Burling LLP
1:30–1:40 PM
Break
1:40–2:55 PM
Premarket Notification 510(k) and De Novo Requests
Jemin Dedania, Director of Regulatory Affairs, Hogan Lovells US LLP
2:55–3:05 PM
Break
3:05–4:20 PM
Premarket Approval Application (PMA); Humanitarian Device Exemption (HDE); Breakthrough Devices
Claire W. Dennis, Associate, Arnold & Porter 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
Wednesday, October 30
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
Kristen Grumet, Senior Vice President, Regulatory Affairs, ELIQUENT Life Sciences
1:30–1:40 PM
Break
1:40–2:40 PM
Enforcement and Compliance
Frederick A. Stearns, Partner, Keller and Heckman LLP
2:40–2:50 PM
Break
2:50–3:50 PM
Promotion and Advertising
Elizabeth Mulkey, Associate, Goodwin Procter LLP
3:50–4:00 PM
Break
4:00–5:00 PM
International Issues
Dennis C. Gucciardo, Partner, Morgan, Lewis & Bockius LLP
5:00 PM
Adjournment