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 (PMA) application 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)
  • Radiation Control for Health and Safety Act of 1968 (RCHSA)
  • 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)
  • Medical Device User Fee Reauthorization Legislation (including Food and Drug Administration Reauthorization Act of 2017 (FDARA))
  • Food and Drug Administration Amendments Act of 2007 (FDAAA)

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

Previous Agenda

subject to change

Curriculum Advisor:
Sonali P. Gunawardhana, Of Counsel, Shook, Hardy & Bacon LLP


Thursday, April 11

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

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
Avia Dunn
, Counsel, Skadden, Slate, Meagher & Flom LLP

9:35 – 10:05AM
Networking and Refreshment Break

10:05 AM – 11:35 PM
Premarket Notification 510(k) and De Novo Applications
Steven S. Tjoe
, Associate, Goodwin Procter LLP

11:35 – 1:00 PM
Networking Lunch

1:00 – 1:45 PM
Registration and Listing
Carolina Wirth
, Counsel, Porzio, Bromberg & Newman, P.C.

1:45 – 2:45 PM
Clinical Investigations: Investigational Device Exemption (IDE), Institutional Review Boards (IRBs),and informed Consent
Kinsey S. Reagan
, Partner, Kleinfeld, Kaplan & Becker, LLP

2:45 – 3:00 PM
Networking and Refreshment Break

3:00 – 4:00 PM
Clinical Investigations: Sponsor Responsibilities and Compliance Issues
Scott D. Danzis
, Partner, Covington & Burling LLP

4:00 –5:00 PM
Premarket Approval Application (PMA); Humanitarian Device Exemption (HDE)
Quynh Hoang
, Senior Regulatory Consultant, King & Spalding LLP

Friday, April 12

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

8:30 – 9:20 AM
Coverage, Coding and Payment – Collaboration Between FDA and the Centers for Medicare and Medicaid Services (CMS)
Michael M. Gaba
, Shareholder, Polsinelli PC

9:20 – 10:40 AM
Post Marketing Issues
Stephanie Philbin
, Counsel, Goodwin Procter LLP

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

10:55 AM – 12:00 PM
Enforcement and Compliance
Sonali P. Gunawardhana
, Of Counsel, Shook, Hardy & Bacon L.L.P.

12:00 – 1:00 PM
Networking Lunch

1:00 – 2:45 PM
Promotion and Advertising
Jennifer A. Henderson
, Partner, Hogan Lovells US LLP

2:45 – 3:00 PM
Networking and Refreshment Break

3:00 – 4:15 PM
Manufacturing and Quality System Regulation (QSR)
Dennis C. Gucciardo
, Counsel, Hogan Lovells US LLP

4:15 – 5:00 PM
International Issues
John F. Johnson, III, Partner, FDAImports.com, LLC/BenjaminL. England & Associates LLC

5:00 PM