Overview

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

Industry & Firms

$1199
  • +$400 for non-members

Non-Profit

$799
  • +$200 for non-members

Government

$799
  • +$200 for non-members

Academic

$799
  • +$200 for non-members

Student

$99
  • full-time students only
Register Now

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A Valuable Reference In Your Preferred Format

Order FDLI’s A Practical Guide to FDA’s Food and Drug Law and Regulation, 7th Edition, now available in e-book and print formats, for an accessible overview to the key legal and regulatory topics.

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: Jeffrey K. Shapiro, Director, Hyman, Phelps & McNamara, PC

Tuesday, November 17

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
Nicholas M. Benetatos, Manager, Exponent

1:05–1:15 PM
Break

1:15–2:30 PM
Premarket Notification 510(k) and De Novo Requests
McKenzie E. Cato, Associate, Hyman, Phelps & McNamara, PC

2:30–2:40 PM
Break

2:40–3:40 PM
Registration and Listing
John Johnson, III, Counsel, Shook, Hardy & Bacon 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
Mahnu Davar, Partner, Arnold & Porter LLP

 

 

Wednesday, November 18

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 Issue
K.S. Reagan, Partner, Kleinfeld, Kaplan & Becker, LLP

1:05–1:15 PM
Break

1:15–2:15 PM
Premarket Approval Application (PMA); Humanitarian Device Exemption (HDE)
Janice M. Hogan, 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)
Cybil Roehrenbeck, Shareholder, Polsinelli PC

3:30–3:45 PM
Break

3:45–5:00 PM
Post Marketing Issues
Steven S. Tjoe, Senior Associate, Goodwin Procter LLP

 

 

 

Thursday, November 19

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 & Heckman LLP

1:05–1:15 PM
Break

1:15–2:35 PM
Promotion and Advertising
Brendan M. Carroll, Partner, Alston & Bird LLP

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
Dennis C. Gucciardo, Partner, Morgan, Lewis & Bockius 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.