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 electronically the day of the course:

Who Should Attend

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

Register

Industry & Firms

$1299
  • +$400 for non-members

Non-Profit

$899
  • +$200 for non-members

Government

$899
  • +$200 for non-members

Academic

$899
  • +$200 for non-members

Student

$99
  • full-time students only
Register Now

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Add This Must-Have Reference to Your Registration

Purchase A Practical Guide to FDA’s Food and Drug Law and Regulation, 7th Edition to have an overview of the key legal and regulatory topics at your fingertips. Order your copy today and it will be shipped directly to your office.

You can transfer your registration to another person at your organization for no cost by notifying us of the change. If you notify FDLI in writing at least five business days prior to the meeting, you can cancel your registration for a full refund (less a $75 fee). Refunds will be applied against the original form of payment.  

Our event policies are listed here. If you should have any further questions, please contact us at [email protected] or 800-956-6293.

Agenda

subject to change

Curriculum Advisor:

Janice M. Hogan, Partner, Hogan Lovells US LLP

 

Tuesday, March 2

12:00 PM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI

12:05–1:05 PM
Overview of Medical Device Law and Regulation and Organizational Structures
Sousan Sheldon, Independent Consultant, EAS Consulting Group

1:05–1:15 PM
Break

1:15–2:30 PM
Premarket Notification 510(k) and De Novo Requests
Michael Kasser, Director of Regulatory Sciences, Hogan Lovells US LLP

2:30–2:40 PM
Break

2:40–3:40 PM
Registration and Listing
Serra J. Schlanger, Director, Hyman, Phelps & McNamara, PC

3:40–3:50 PM
Break

3:50–5:00 PM
Clinical Investigations: Investigational Device Exemption (IDE), Institutional Review Boards (IRBs), and informed Consent
Mahnu Davar, Partner, Arnold & Porter LLP

 

 

Wednesday, March 3

12:00 PM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI

12:05–1:05 PM
Clinical Investigations: Sponsor/Investigator Responsibilities and Compliance Issues
Anisa Mohanty, Counsel, McDermott Will & Emory LLP

1:05–1:15 PM
Break

1:15–2:15 PM
Premarket Approval Application (PMA); Humanitarian Device Exemption (HDE)
Deborah Baker-Janis, Senior Director, NSF International

2:15–2:30 PM
Break

2:30–3:30 PM
Coverage, Coding and Payment – Collaboration Between FDA and the Centers for Medicare and Medicaid Services (CMS)
Preeya Noronha Pinto, Partner, King & Spalding LLP

3:30–3:45 PM
Break

 3:45–5:00 PM
Post Marketing Issues
Ian M. Pearson, Associate, Jones Day

 

 

 

Thursday, March 4

12:00 PM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI

12:05–1:05 PM
Enforcement and Compliance
Frederick A. Stearns, Partner, Keller and Heckman LLP

1:05–1:15 PM
Break

1:15–2:35 PM
Promotion and Advertising
Suzanne Levy Friedman, Senior Associate, Hogan Lovells US LLP

2:35–2:50 PM
Break

2:50–3:50 PM
Manufacturing and Quality System (QS) Regulation
Allison Fulton, Partner, Sheppard Mullin Richter & Hamilton LLP

3:50–4:00 PM
Break

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.