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:

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

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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.

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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
All times are in Eastern Time

Curriculum Advisor:

Janice M. Hogan, Partner, Hogan Lovells US LLP

 

Tuesday, November 16

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

1:05–1:15 PM
Break

1:15–2:30 PM
Premarket Notification 510(k) and De Novo Requests
Ryan M. Fournier, Partner, Wiley

2:30–2:40 PM
Break

2:40–3:40 PM
Registration and Listing
Abeba Habtemariam, Counsel, Arnold & Porter LLP

3:40–3:50 PM
Break

3:50–5:00 PM
Clinical Investigations: Investigational Device Exemption (IDE), Institutional Review Boards (IRBs), and informed Consent
Blake E. Wilson, Senior Associate, Hogan Lovells US LLP

Wednesday, November 17

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
Rebecca Jones McKnight, Partner, DLA Piper LLP (US)

1:05–1:15 PM
Break

1:15–2:15 PM
Premarket Approval Application (PMA); Humanitarian Device Exemption (HDE)
Kristin M. Zielinski Duggan, Partner, Hogan Lovells US LLP

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)
Michael M. Gaba, Shareholder, Polsinelli PC

3:30–3:45 PM
Break

3:45–5:00 PM
Post Marketing Issues
Michael Chellson, Principal Consultant, NSF International
Dhanmati Rupnarine, Principal Consultant, NSF International

 

 

Thursday, November 18

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

12:05–1:05 PM
Enforcement and Compliance
Gregory H. Levine, Partner, Ropes & Gray LLP
Beth P. Weinman, Counsel, Ropes & Gray LLP

1:05–1:15 PM
Break

1:15–2:35 PM
Promotion and Advertising
James R. Ravitz, Partner, Wilson Sonsini Goodrich & Rosati
Georgia C. Ravitz, Partner, Wilson Sonsini Goodrich & Rosati

2:35–2:50 PM
Break

2:50–3:50 PM
Manufacturing and Quality System (QS) Regulation
Elaine H. Tseng, Partner, King & Spalding LLP

3:50–4:00 PM
Break

4:00–5:00 PM
International Issues
John F. Johnson, III, Of Counsel, Shook, Hardy & Bacon LLP

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.