Day 1


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


Overview of Medical Device Law and Regulation and Organizational Structures
McKenzie Cato, Associate, Hyman, Phelps & McNamara, PC

Watch this session here.

Combination Products
James A. Boiani, Partner, Epstein Becker & Green, PC
Megan Robertson, Associate, Epstein Becker & Green, PC

Watch this session here.

11:00 AM 

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

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11:05–11:50 AM 

Digital Health
Allison Fulton, Partner, Sheppard Mullin Richter & Hampton LLP

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11:50 AM–12:00 PM 


12:00–1:30 PM 

Clinical Investigations
Anisa Mohanty, Counsel, McDermott Will & Emory

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1:30–1:40 PM


1:40–2:55 PM

Premarket Notification 510(k) and De Novo Requests
Sarah Rys, Sr. Principal Regulatory Affairs Specialist, Medtronic      

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2:55–3:05 PM


3:05–4:20 PM

Premarket Approval Application (PMA); Humanitarian Device Exemption (HDE); Breakthrough Devices
Deborah Baker-Janis, Senior Director, NSF International   

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4:20–4:30 PM


4:30–5:30 PM

Coverage, Coding and Payment – Collaboration Between FDA and the Centers for Medicare and Medicaid Services (CMS)
Cybil Roehrenbeck, Partner, Hogan Lovells US 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.