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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 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

Register by March 14 and SAVE!

Industry & Firms

$1199
  • +$400 for non-members
  • +$100 after 3/14/2019

Non-Profit

$799
  • +$200 for non-members
  • +$100 after 3/14/2019

Government

$799
  • +$200 for non-members
  • +$100 after 3/14/2019

Academic

$799
  • +$200 for non-members
  • +$100 after 3/14/2019

Student

$99
  • full-time students only
  • transcripts required
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:
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 – 10:15 AM
Overview of Medical Device Law and Regulation

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

10:30 AM – 12:00 PM
Premarket Notification 510(k) and De Novo Applications

12:00 – 1:00 PM
Networking Lunch

1:00 – 1:45 PM
Registration and Listing

1:45 – 2:45 PM
Clinical Investigations: Investigational Device Exemption (IDE), Institutional Review Boards (IRBs),and informed Consent

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

3:00 – 4:00 PM
Clinical Investigations: Sponsor Responsibilities and Compliance Issues

4:00 –5:00 PM
Premarket Approval Application (PMA); Humanitarian Device Exemption (HDE)

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)

9:20 – 10:40 AM
Post Marketing Issues

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

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

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

5:00 PM
Adjournment

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.

Virginia: approved for 13.0 CLE credit hours
Pennsylvania: approved for 13.5 CLE credit hours

Location and Overnight Accommodations

Course Location

Hogan Lovells US LLP
Columbia Square
555 Thirteen Street, NW
Washington, DC 20004

Parking and Public Transportation

Hogan Lovells is located one block walk from Metro Center Station.   Parking is available at the Columbia Square Parking Garage located on the 12th street side of Hogan Lovells’ building, between E & F Streets, with parking costs of $13/hour or $21/full day. 

Overnight Accommodations

A block of rooms has been reserved for course attendees at the JW Marriott Hotel.   The JW Marriott is a short walk from the course location.  Reservations can be made online and must be received by Friday, March 15 to obtain the $319 group rate.  After this date, rooms will be subject to prevailing rates and availability.   

2019-02-20T12:01:06+00:00