Introduction to Medical Device Law and Regulation

April 9–10, 2024   Washington, DC   In-Person Course

Preliminary Agenda

Agenda Subject to Change
All times are in Eastern Time

2024 Curriculum Advisor:
Steven S. Tjoe, Partner, Goodwin Procter LLP

Tuesday, April 9

8:00–8:30 AM
Registration and Continental Breakfast

8:30–8:35 AM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI

8:35–9:35 AM
Overview of Medical Device Law and Regulation and Organizational Structures

9:35–9:50 AM
Networking Break

9:50–10:35 AM
Combination Products

10:35–10:50 AM
Networking Break                                   

10:50–11:35 AM
Digital Health

11:35 AM–12:35 PM
Networking Lunch

12:35–1:55 PM
Clinical Investigations

1:55–2:10 PM
Networking Break

2:10–3:30 PM
Premarket Notification 510(k) and De Novo Requests

3:30–3:45 PM
Networking Break

3:45–5:00 PM
Premarket Approval Application (PMA); Humanitarian Device Exemption (HDE); Breakthrough Devices

Wednesday, April 10

8:00–8:30 AM
Registration and Continental Breakfast

8:30–8:35 AM
FDLI Welcome and Announcements

8:35–9:35 AM
Coverage, Coding and Payment – Collaboration Between FDA and the Centers for Medicare and Medicaid Services (CMS)

9:35–9:50 AM
Networking Break

9:50–11:05 AM
Post Marketing Issues

11:05–11:20 AM
Networking Break

11:20 AM–12:20 PM
Manufacturing and Quality System (QS) Regulation

12:20–1:20 PM
Networking Lunch

1:20–2:30 PM
Enforcement and Compliance

2:30–2:45 PM
Networking Break

2:45–3:45 PM
Promotion and Advertising

3:45–4:00 PM
Networking Break                                     

4:00–5:00 PM
International Issues

5:00 PM
Adjournment