Resources

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

Tuesday, November 9

11:00 – 11:05 AM

Welcome and Course Overview

Laura Brown, Director, Educational Programs, FDLI
Enter this session: https://fdli.zoom.us/j/87230765986

11:05 AM – 12:00 PM 

I.  Is My Digital Health Product a Medical Device Regulated by FDA?
Shelby Buettner, Principal Legal Counsel, Medtronic
M. Jason Brooke, Attorney &Managing Member, Brooke Consulting, LLC

A special thank you to Laura Bailis, Associate Corporate Counsel, Google, for her contributions to the content of this presentation

Enter this session: https://fdli.zoom.us/j/87230765986

12:00 – 12:15 PM 

Break

12:15 – 1:15 PM 

II. What Regulatory Pathway Applies to My Digital Health Product? What Are Other Relevant Considerations?
Jeffrey K. Shapiro, Director, Hyman, Phelps & McNamara, PC

Enter this session: https://fdli.zoom.us/j/83890542548

1:15 – 1:45 PM

Break

1:45 – 2:45 PM

III.  What Post-Marketing Issues Should I Be Considering?
Christine P. Bump, Principal, Penn Avenue Law & Policy

Enter this session: https://fdli.zoom.us/j/84866031981

2:45 – 3:00 PM

Break

3:00 – 3:45 PM

IV. What Advertising and Promotion Requirements Apply?
Kyle Y. Faget, Partner, Foley & Lardner LLP

Enter this session: https://fdli.zoom.us/j/82673985849

FDLI would like to thank Curriculum Advisor Shelby Buettner, Principal Legal Counsel, Medtronic for her help in planning this course and for her assistance and support of FDLI’s Educational Programs.

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Test your device: https://support.zoom.us/hc/en-us/articles/201362193-Joining-a-meeting

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