Explore the essentials of device law and regulation and gain a comprehensive understanding of the administrative agencies that impact this industry. Learn about registration and listing procedures, elements of conducting clinical investigations, Premarket Approval Application, advertising and promotion, compliance, enforcement, and related issues. Case studies, hypotheticals, and ample time for Q&A are provided.

 

Agenda Highlights

  • Overview of the organizational structure of the FDA
  • FDA’s regulatory process for medical devices
  • How to prepare a successful 510(k) submission
  • Registration and listing requirements
  • Elements of conducting clinical investigations
  • Premarket Approval Application (PMA) and approval process
  • Post-marketing requirements
  • FDA’s enforcement tools and procedures
  • Advertising and promotion requirements
  • Quality System Regulation (QSR)

Statutes Covered

  • Federal Food, Drug & Cosmetic Act (FD&C Act)
  • 1976 Medical Device Amendment
  • Safe Medical Devices Act of 1990 (SMDA)
  • Mammography Quality Standard Act of 1992 (MQSA)
  • Food and Drug Administration Modernization Act of 1997 (FADAMA)
  • Food and Drug Administration Amendments Act of 2007 (FDAAA)
  • 21st Century Cures Act (2016)
  • Medical Device User Fee Reauthorization Legislation (including Food and Drug Administration Reauthorization Act of 2017 (FDARA))

Attendee Resources

These valuable takeaways will be provided onsite:

Who Should Attend

  • New legal and regulatory professionals
  • Seasoned practitioners new to the topic or wanting a refresher

Agenda

subject to change
Curriculum Advisor: Jeffrey K. Shapiro, Director, Hyman, Phelps & McNamara, PC

Tuesday, April 7

8:30–8:35 AM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI

8:35–9:35 AM
Overview of Medical Device Law and Regulation
McKenzie E. Cato, Associate, Hyman, Phelps & McNamara, PC

9:35–9:50 AM
Break

9:50–11:35 AM
Premarket Notification 510(k) and De Novo Applications
Jeffrey K. Shapiro, Director, Hyman, Phelps & McNamara, PC

11:35 AM–12:35 PM
Lunch Break

12:35–1:35 PM
Registration and Listing
John Johnson, III, Counsel, Shook, Hardy & Bacon LLP

1:35–2:45 PM
Clinical Investigations: Investigational Device Exemption (IDE), Institutional Review Boards (IRBs), and informed Consent
Blake E. Wilson, Senior Associate, Hogan Lovells US LLP

2:45–3:00 PM
Break

3:00–4:00 PM
Clinical Investigations: Sponsor Responsibilities and Compliance Issues
Christina Kuhn, Associate, Covington & Burling LLP
Amy Leiser, Associate, Covington & Burling LLP

4:00–5:00 PM
Premarket Approval Application (PMA); Humanitarian Device Exemption (HDE)
Janice M. Hogan, Partner, Hogan Lovells US LLP

 

 

Wednesday, April 8

8:00–8:30 AM
Registration and Continental Breakfast

8:30–9:30 AM
Manufacturing and Quality System Regulation (QSR)
Allison Fulton, Partner, Sheppard Mullin Richter & Hampton LLP

9:30–10:40 AM
Post Marketing Issues
Marc J. Scheineson, Partner, Alston & Bird LLP
Benjamin Wolf, Senior Associate, Alston & Bird LLP

10:40–10:55 AM
Networking and Refreshment Break

10:55 AM–12:00 PM
Enforcement and Compliance
Frederick A. Stearns, Partner, Keller & Heckman LLP

12:00–1:00 PM
Networking Lunch

1:00–2:30 PM
Promotion and Advertising
Carolina Wirth,Of Counsel, Arnall Golden Gregory LLP
Genevieve M. Razick, Associate, Arnall Golden Gregory LLP

2:30–2:45 PM
Networking and Refreshment Break

2:45–4:00 PM

Coverage, Coding and Payment–Collaboration Between FDA and the Centers for Medicare and Medicaid Services (CMS)
Cybil Roehrenbeck, Shareholder, Polsinelli PC

4:00–5:00 PM
International Issues
Sarah H. Stec, Senior Counsel, Medical Device Regulatory Law, Johnson & Johnson

5:00 PM
Adjournment

 

 

 

Continuing Legal Education

FDLI applies for CLE credits in Ohio and Virginia. These CLE approvals also may be honored by other states. The CLE credits will be posted as they are granted and registrants can request to be notified when approval is received.