Preliminary Agenda

Agenda Subject to Change
All Times Listed in Eastern Time

Preconference Primers

Preconference Primer (Virtual) (60 Minutes)
Overview of Medical Device Law and Regulation and Organizational Structures

Preconference Primer (Virtual) (45 Minutes)
Combination Products

Day 1

11:00 AM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI

11:05–11:50 AM
Digital Health

11:50 AM–12:00 PM
Break

12:00–1:30 PM
Clinical Investigations

1:30–1:40 PM
Break

1:40–2:55 PM
Premarket Notification 510(k) and De Novo Requests

2:55–3:05 PM
Break

3:05–4:20 PM
Premarket Approval Application (PMA); Humanitarian Device Exemption (HDE); Breakthrough Devices

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)

Day 2

11:00 AM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI

11:05 AM–12:20 PM
Post Marketing Issues

12:20–12:30 PM
Break

12:30–1:30 PM
Manufacturing and Quality System (QS) Regulation

1:30–1:40 PM
Break 

1:40–2:40 PM
Enforcement and Compliance

2:40–2:50 PM
Break

2:50–3:50 PM
Promotion and Advertising

3:50–4:00 PM
Break

4:00–5:00 PM
International Issues

5:00 PM
Adjournment