Day 1
Please find the session links next to their corresponding agenda item.
Prerecorded
Overview of Medical Device Law and Regulation and Organizational Structures
Kristin M. Zielinski Duggan, Partner, Hogan Lovells US LLP
Watch this session here.
Combination Products
Alan G. Minsk, Partner, Arnall Golden Gregory LLP
Laura S. Dona, Associate, Arnall Golden Gregory LLP
Watch this session here.
Wednesday, April 13
11:00 AM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI
Enter this session: https://fdli.zoom.us/j/86321668158
11:05 – 11:50 AM
Digital Health
Kyle Y. Faget, Partner, Foley & Lardner LLP
Enter this session: https://fdli.zoom.us/j/86321668158
11:50 AM – 12:00 PM
Break
12:00 – 1:30 PM
Clinical Investigations
Samantha Hong, Associate, Kleinfeld, Kaplan & Becker, LLP
Enter this session: https://fdli.zoom.us/j/86863681225
1:30 – 1:40 PM
Break
1:40 – 2:55 PM
Premarket Notification 510(k) and De Novo Requests
Maura Martin Norden, Executive Vice President, Medical Products & Combination Products, Greenleaf Health, Inc.
Heather S. Rosecrans, Executive Vice President, Medical Products & Combination Products, Greenleaf Health, Inc.
Enter this session: https://fdli.zoom.us/j/83217067233
2:55 – 3:05 PM
Break
3:05 – 4:20 PM
Premarket Approval Application (PMA); Humanitarian Device Exemption (HDE); Breakthrough Devices
Quynh Hoang, Senior Regulatory Consultant, King & Spalding LLP
Enter this session: https://fdli.zoom.us/j/89272824825
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
Enter this session: https://fdli.zoom.us/j/84769389505
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 Coleen Carney at [email protected].
Test your device: https://support.zoom.us/hc/en-us/articles/201362193-Joining-a-meeting
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.