Please find the session links next to their corresponding agenda item.

Tuesday, November 16

12:00 PM 

FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI

Enter this session:

12:05 – 1:05 PM 

Overview of Medical Device Law and Regulation and Organizational Structures
Justine E. Lenehan, Associate, Kleinfeld, Kaplan, & Becker, LLP

Enter this session:

1:05 – 1:15 PM 


1:15 – 2:30 PM 

Premarket Notification 510(k) and De Novo Requests
Ryan M. Fournier, Partner, Wiley

Enter this session:

2:30 – 2:40 PM


2:40 – 3:40 PM

Registration and Listing
Abeba Habtemariam, Counsel, Arnold & Porter LLP

Enter this session:

3:40 – 3:50 PM


3:50 – 5:00 PM

Clinical Investigations: Investigational Device Exemption (IDE), Institutional Review Boards (IRBs), and informed Consent
Blake E. Wilson, Senior Associate, Hogan Lovells US LLP

Enter this session:

An access link will be provided to attendees via email upon registration.

If you are registering on behalf of someone else, the link to access the webinar will go to the email address provided at the point of registration.

Those registering on the day of the webinar will receive an access link via email upon successful payment.


We use Zoom to conduct webinars which works on most devices. You may participate in the webinar on a mobile device via the Zoom App or by dialing in. If you require the dial in information, please contact Maura Schatz at [email protected].

Test your device:


Webinar recordings are sent via email as soon as we are able to process and verify the quality of the recording. This usually occurs within 3 business days of a webinar broadcast.

If multiple people at your organization wish to participate from separate devices, each will be required to purchase access.