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)
  • 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 nonmembers


  • +$200 for nonmembers


  • +$200 for nonmembers


  • +$200 for nonmembers


  • student registration
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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:  
Ellen J. Flannery, Deputy Center Director for Policy, Office of the Center Director, CDRH, FDA

Wednesday, November 7

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

8:30–8:35 AM
FDLI Welcome and Announcements

8:35–10:15 AM
Overview of Medical Device Law and Regulation
Kristin M. Zielinski Duggan
, Counsel, Hogan Lovells US LLP

10:15–10:30 AM
Networking and Refreshment Break

10:30 AM–12:00 PM
Premarket Notification 510(k) and De Novo Applications
Michele L. Buenafe
, Partner, Morgan, Lewis & Bockius LLP
Ryan M. Fournier, Associate, Morgan, Lewis & Bockius LLP

12:00–1:30 PM
Networking Lunch

1:30–2:00 PM
Registration and Listing
Michelle C. Jackson
, Partner, Venable LLP

2:00–3:00 PM
Clinical Investigations: Investigational Device Exemption, Institutional Review Boards, and Informed Consent
Danielle C. Humphrey
, Counsel, Hogan Lovells US LLP

3:00–3:15 PM
Networking and Refreshment Break

3:15–4:10 PM
Clinical Investigations: Sponsor Responsibilities and Compliance Issues
Scott D. Danzis
, Partner, Covington & Burling LLP

4:10–5:00 PM
Premarket Approval Application (PMA); Humanitarian Device Exemption (HDE)
Judith L. O’Grady
, Partner, Pepper Hamilton LLP

Thursday, November 8

8:00–8:30 AM
Continental Breakfast

8:30–9:20 AM
Coverage, Coding and Payment: Collaboration Between FDA and the CMS
Preeya Noronha Pinto
, Partner, King & Spalding LLP

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
Gregory H. Levine
, Partner, Ropes & Gray LLP

12:00–1:00 PM
Networking Lunch

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

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

3:00–4:15 PM
Manufacturing and Quality System (QS) Regulation
Sonali P. Gunawardhana
, Of Counsel, Shook, Hardy & Bacon L.L.P.
Sean Lee, Associate, Shook, Hardy & Bacon L.L.P.

4:15–5:00 PM
International Issues
Sonali P. Gunawardhana
, Of Counsel, Shook, Hardy & Bacon L.L.P.
Sean Lee, Associate, Shook, Hardy & Bacon L.L.P.

5:00 PM

Continuing Legal Education

FDLI applies for CLE credits in Illinois, Ohio, Pennsylvania, 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.

Illinois: approved for 13.25 CLE credit hours

Location and Overnight Accommodations


Ropes & Gray
2099 Pennsylvania Ave NW
Washington, DC 20006

Parking and Public Transportation

By Metro: Take the silver, blue or orange line Metro to Foggy Bottom Metro Station and walk .23 miles east to the venue.
Parking: There is a Colonial Parking garage located on 21st Street, NW near the corner of Pennsylvania Avenue, NW.

Overnight Accommodations 

A block of rooms has been reserved for course attendees at the Residence Inn Washington, DC/Dupont Circle.  The group rate is $309/night plus tax. Reservations can be made online and  must be received by October 9, 2018 to receive the group rate. After this date, rooms will be subject to prevailing rates and availability.

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