Explore the essentials of device law and regulation and gain a comprehensive understanding of the various 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 is 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 (FDAMA)
  • Medical Device User Fee and Modernization Act of 2002 (MDUFMA)
  • Food and Drug Administration Amendments Act of 2007 (FDAAA)

This course is designed for attorneys and other professionals needing an overview of the topic. No prior knowledge of device law and regulation is needed. Attendee Resources These valuable takeaways will be provided onsite:

Register

Industry & Firms

$1199
  • +$400 for nonmembers

Non-Profit

$799
  • +$200 for nonmembers

Government

$799
  • +$200 for nonmembers

Academic

$799
  • +$200 for nonmembers

Student

$99
  • +$100 for nonmembers

Add This Must-Have Reference to Your Registration

Access to an electronic version of the FDCA Statutory Supplement, 2017 is included in your registration. You can also purchase a print copy at a $100 savings during course registration. Select the “bundle option” to take advantage of this offer. The book will be immediately shipped directly to you.

Agenda

subject to change

Wednesday, April 26

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

Jacqueline Chan, Associate, Kleinfeld, Kaplan & Becker, LLP

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

10:30 AM–12:00 PM
Premarket Notification 510(k)

12:00–1:30 PM
Networking Lunch

1:30–2:00 PM
Registration and Listing

Carolina Wirth, Counsel, Kilpatrick Townsend & Stockton LLP

2:00–3:00 PM
Clinical Investigations: Investigational Device Exemption (IDE), Institutional Review Boards (IRBs) and informed Consent

Mahnu Davar, Partner, Arnold & Porter Kaye Scholer LLP

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

3:15–4:10 PM
Clinical Investigations: Sponsor Responsibilities and Compliance Issues

Mahnu Davar, Partner, Arnold & Porter Kaye Scholer LLP

4:10–5:00 PM
Premarket Approval Application (PMA)

Kristin Duggan Zielinski, Counsel, Hogan Lovells LLP

5:00–6:00 PM
Networking Reception

Thursday, April 27

8:00–8:30 AM
Continental Breakfast

8:30–9:20 AM
Coverage, Coding and Payment – Collaboration Between FDA and the Centers for Medicare and Medicaid Services (CMS)

9:20–10:40 AM
Post Marketing Issues

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

10:55 AM–12:00 PM
Enforcement and Compliance

Brandon Moss, Associate, Wiley Rein LLP

12:00–1:00 PM
Networking Lunch

1:00–2:45 PM
Promotion and Advertising

James Ravitz, Partner, Arent Fox LLP
Paul Gadiock, Senior Attorney, Arent Fox LLP

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

3:00–4:15 PM
Quality System (QS) Regulation

Abram Barth, Senior Associate, Ropes & Gray LLP

4:15–5:00 PM
International Issues

5:00 PM
Adjournment

Speaker Biographies

Speaker biographies will be posted as they become available.

Continuing Legal Education

FDLI applies for CLE credits in 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.

Location and Overnight Accommodations

Course Location

Arent Fox LLP
1717 K St NW
Washington, DC 20036

Overnight Accommodations

Hyatt Place, 1522 K Street NW
Capital Hilton, 1001 16th Street NW
The Mayflower Hotel, 1127 Connecticut Avenue NW
Hotel RL, 1823 L Street NW

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