Resources

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

Tuesday, November 9

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

Watch this session: https://fdli.vids.io/videos/4d9dd7bd1314e7c4c4/fdli-fundamentals-course-session-1-welcome-and-is-my-digital-health-product

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.vids.io/videos/709dd7bd1316e0c0f9/fdli-fundamentals-course-session-2-what-regulatory-pathway-applies-to-my-digital-health-product-what-ae-other-relevant-considerations

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

Watch this session: https://fdli.vids.io/videos/799dd7bd1313e2c2f0/fdli-fundamentals-course-session-3-what-post-marketing-issues-should-i-be-considering

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

Enter this session: https://fdli.vids.io/videos/449dd7bd1312ecc4cd/fdli-fundamentals-course-session-4-what-advertising-and-promotion-requirements-apply

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.