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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 and Modernization Act of 2002 (MDUFMA)
  • Food and Drug Administration Amendments Act of 2007 (FDAAA)

Attendee Resources

These valuable takeaways will be provided onsite:

Who Should Attend

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
  • full-time students only
Register Now


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.

Agenda

subject to change

Curriculum Advisor:  
Ellen J. Flannery, Deputy Center Director for Policy, Office of the Center Director, CDRH, FDA

Wednesday, July 25

4:00 PM
A Presentation and Panel Discussion: FDA’s Digital Health Innovation Action Plan – Key Updates
Being held nearby. A separate registration is required.

Thursday, July 26

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

8:35–10:15 AM
Overview of Medical Device Law and Regulation
Avia Dunn
, Associate, Skadden, Arps, Slate, Meagher & Flom LLP

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

10:30 AM–12:00 PM
Premarket Notification 510(k)
Yarmela Pavlovic
, Partner, Hogan Lovells US LLP

12:00–1:30 PM
Networking Lunch

1:30–2:00 PM
Registration and Listing
Tom Anderton
, Of Counsel, Squire Patton Boggs LLP

2:00–3:00 PM
Clinical Investigations: Investigational Device Exemption, Institutional Review Boards, and Informed Consent
Mahnu Davar
, Partner, Arnold & Porter LLP

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

3:15–4:10 PM
Clinical Investigations: Sponsor Responsibilities and Compliance Issues
Mahnu Davar
, Partner, Arnold & Porter LLP

4:10–5:00 PM
Premarket Approval Application
Deborah Baker-Janis
, Senior Director, NSF Medical Devices, NSF International

 

Friday, July 27

8:00–8:30 AM
Continental Breakfast

8:30–9:20 AM
Coverage, Coding and Payment: Collaboration Between FDA and the CMS
Michael M. Gaba
, Shareholder, Vice Chair, FDA Practice Group, 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
Frederick A. Stearns
, Partner, Keller and Heckman LLP

12:00–1:00 PM
Networking Lunch

1:00–2:45 PM
Promotion and Advertising
Marian J. Lee
, Partner, Gibson Dunn & Crutcher LLP

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

3:00–4:15 PM
Quality System Regulation
Elaine H. Tseng
, Partner, King & Spalding LLP

4:15–5:00 PM
International Issues
Frederick A. Stearns
, Partner, Keller and Heckman LLP

5:00 PM
Adjournment

 

Continuing Legal Education

FDLI applies for CLE credits in California, 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.

13.25 credits in OH
13.5 credits in Pennsylvania
13.5 credits in Virginia

Course Location

California Life Sciences Association Event Center
701 Gateway Blvd, Suite 440
South San Francisco, CA 94080

Hotel

A block of rooms has been reserved for course attendees at the AC Hotel San Francisco Airport/Oyster Point Waterfront. The group rate is $279/night plus tax. Reservations can be made online or by calling 1-888-236-2427. Reservations must be received by June 29, 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.

2018-07-27T12:55:53+00:00