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
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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

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12:00 – 12:15 PM 


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

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1:15 – 1:45 PM


1:45 – 2:45 PM

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

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2:45 – 3:00 PM


3:00 – 3:45 PM

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

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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.

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].

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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.