Updates for 2022

FDLI remains committed to providing high-quality educational programs in a way that keeps our members and event attendees safe. With this in mind, we are excited to announce that the Introduction to Medical Device Law and Regulation course will be a hybrid event (both in-person and virtual). Please note that all in-person plans are subject to change as needed to protect the health and safety of the FDLI community.

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

Register by Fall 2022 and SAVE!

Industry & Firms

$1299
  • +$200 for non-members
  • +$100 Fall 2022

Non-Profit

$799
  • +$200 for non-members
  • +$100 Fall 2022

Government

$799
  • +$200 for non-members
  • +$100 Fall 2022

Academic

$799
  • +$200 for non-members
  • +$100 Fall 2022

Student

$99
Register Now

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To ensure that FDLI is able to provide you with a seat, materials, and meals, please register for programs at least 48 hours in advance. While onsite registration is available on a “space-available” basis; late registrants are not guaranteed materials or meals.

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.

Last Year’s Agenda

 

subject to change
All times are in Eastern Time

2022 Curriculum Advisor:

Scott Danzis, Partner, Covington & Burling 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 may also be honored by other states; please check with your bar association for guidance. The CLE credits will be posted as they are granted and you can request to be notified when approval is received.

 

Location and Overnight Accommodations

Conference Location

1032 15th Street, NW
Washington, DC 20005

Parking and Public Transportation

Overnight Accommodations

Please contact the Conference Department with any accessibility requirements or dietary restrictions, or for other questions.