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

Overview of Medical Device Law and Regulation and Organizational Structures
McKenzie E. Cato, Associate, Hyman, Phelps & McNamara, P.C.

Watch this session here.

Combination Products
James A. Boiani, Member of the Firm, Epstein Becker & Green, PC
Megan Robertson, Associate, Epstein Becker & Green, PC

Watch this session here.

 

 

 

Wednesday, October 11

 

11:00 AM 

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

Enter this session: https://fdli.zoom.us/j/82633993920?pwd=XJ9la1iNAKYWtcY4x25eEgcID8jTX7.1

11:05–11:50 AM 

 

Digital Health
Bethany J. Hills, Partner, DLA Piper LLP (US)

Enter this session: https://fdli.zoom.us/j/82633993920?pwd=XJ9la1iNAKYWtcY4x25eEgcID8jTX7.1

11:50 AM–12:00 PM 

 

Break

12:00–1:30 PM 

Clinical Investigations
Justine E. Lenehan, Associate, Kleinfeld, Kaplan & Becker, LLP

Enter this session: https://fdli.zoom.us/j/85834961973?pwd=42dBOT7ZqlnpGt57rFd39kbcJdHH3O.1

1:30 – 1:40 PM

Break

1:40–2:55 PM

Premarket Notification 510(k) and De Novo Requests
Kristin R. Davenport, Partner, Covington & Burling LLP
Olivia Dworkin, Associate, Covington & Burling LLP

Enter this session: https://fdli.zoom.us/j/86771171716?pwd=yAxexDv6bzTKVkaQguWzfh54kdG4T3.1

2:55–3:05 PM

Break

3:05–4:20 PM

 

Premarket Approval Application (PMA); Humanitarian Device Exemption (HDE); Breakthrough Devices
Lina R. Kontos, Partner, Hogan Lovells US LLP

Enter this session: https://fdli.zoom.us/j/84473876974?pwd=SaIuQzJUeAalG7Yki40uz7SuARBlVl.1

4:20–4:30 PM

 

Break

4:30–5:30 PM

 

Coverage, Coding and Payment – Collaboration Between FDA and the Centers for Medicare and Medicaid Services (CMS)
Michael M. Gaba, Shareholder, Polsinelli PC

Enter this session: https://fdli.zoom.us/j/84394734438?pwd=YPj8ZFmW2k7Io2hR7IJn7Xkz1tEdP8.1

CLE Information

Ohio

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.

Virginia

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 www.vsb.org. 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.