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

venue sponsor


Industry & Firms

  • +$400 for non-members


  • +$200 for non-members


  • +$200 for non-members


  • +$200 for non-members


  • full-time students only

A Valuable Reference
Purchase A Practical Guide to FDA’s Food and Drug Law Regulation, 6th 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.

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.


subject to change

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


Wednesday, November 13

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

Nicholas M. Benetatos, Manager, Exponent, Inc.

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

10:05–11:35 AM
Premarket Notification 510(k) and De Novo Applications
Lindsay P. Holmes
, Associate, BakerHostetler

11:35 AM–1:00 PM
Networking Lunch

1:00–1:45 PM
Registration and Listing
Sean Lee
, Of Counsel, Shook, Hardy & Bacon LLP

1:45–2:45 PM
Clinical Investigations: Investigational Device Exemption (IDE), Institutional Review Boards (IRBs), and informed Consent
Blake E. Wilson
, Senior Associate, Hogan Lovells US 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
Amy Leiser, Associate, Covington & Burling LLP

 4:00–5:00 PM
Premarket Approval Application (PMA); Humanitarian Device Exemption (HDE)
Blake E. Wilson
, Sr. Associate, Hogan Lovells US LLP


Thursday, November 14

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)
Preeya Myrtle Noronha Pinto
, Partner, King & Spalding LLP

9:20–10:40 AM
Post Marketing Issues
Steven S. Tjoe
, Associate, Goodwin Proctor 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 LLP

12:00–1:00 PM
Networking Lunch

1:00–2:45 PM
Promotion and Advertising
Jessica Ringel
, Counsel, King & Spalding LLP
Gillian M. Russell
, Counsel, King & Spalding LLP

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

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

4:15–5:00 PM
International Issues
John Johnson, III
, Senior Associate, FDAImports.com, LLC/Benjamin L. England & Associates LLC

5:00 PM






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.

Pennsylvania: approved for 13.5 CLE credit hours

Location and Overnight Accommodations

Course Location

Shook, Hardy & Bacon LLP

1800 K Street NW
Suite 1000
Washington, DC 20006

Overnight Accommodations

A block of rooms has been reserved at the JW Marriott for conference attendees at the special group rate of $295/night, not inclusive of taxes. Reservations can be made online and must be received by Tuesday, October 15, 2019 to receive the group rate. After this date, it is at the hotel’s discretion whether to accept additional reservations, which will be subject to prevailing rates and availability.

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