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

Wednesday, November 30

11:00–11:05 AM

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

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11:05 AM–12:00 PM 

I.  Is My Digital Health Product a Medical Device Regulated by FDA?
Gbenga Awotunde, Genentech Inc.
Imein Bousnina, Associate Program Director, US Regulatory Policy, Genentech, Inc.

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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 Ae Other Relevant Considerations in Digital Health?   
Jeffrey Ballyns, Associate Director, Regulatory Policy, Becton Dickinson (BD)

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1:15 – 1:45 PM


1:45–2:45 PM

III.  What Post-Marketing Issues Should I Be Considering?
Stephanie Philbin, Partner, Goodwin Procter LLP

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2:45–3:00 PM


3:00–3:45 PM

IV.  What Advertising and Promotion Requirements Apply? 
Lisa M. Dwyer, Partner, King & Spalding LLP

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CLE Information


This event is pending approval in Ohio. To obtain credit, please email [email protected] at the end of the conference and include your state bar number along with how many credits you wish to obtain. FDLI will certify your attendance for you. An evaluation is required to obtain credit.


This event is pending approval in Virginia. Please email [email protected] to request a Virginia form. You will need to certify your attendance online at Retain the Certificate of Attendance for two years.

Other States

These CLE approvals may also be honored by other states; please check with your bar association for guidance. At the end of the conference, please email [email protected] to receive a certificate of attendance.