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