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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

  • New legal and regulatory professionals
  • Seasoned practitioners new to the topic or wanting a refresher

Venue Sponsor

 

 New to Food and Drug Law Group

Enhance Your Career

Registration

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
Register Now

 

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.

 

Add This Must-Have Reference to Your Registration

Access to an electronic version of the FDCA Statutory Supplement, 2018 is included in your registration. You can also purchase a print copy at a $100 savings during course registration. The book will be shipped directly to you.

Agenda

subject to change

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

Thursday, April 12

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
James A. Boiani, Member of the Firm, Epstein Becker & Green, P.C.
Gail H. Javitt, Member of the Firm, Epstein Becker & Green, P.C.

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

10:30 AM–12:00 PM
Premarket Notification 510(k) and De Novo Applications
Stephanie Philbin, Counsel, Goodwin Procter 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
KS Reagan
, Partner, Kleinfeld, Kaplan & Becker, LLP

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

3:15–4:10 PM
Clinical Investigations: Sponsor Responsibilities and Compliance Issues
Vernessa T. Pollard
, Partner, McDermott Will & Emory

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

5:00-6:00 pm
Networking Reception – Civiletti Center Lobby
Hosted by Venable

 

Friday, April 13

8:00–8:30 AM
Registration Continental Breakfast

8:30–9:20 AM
Coverage, Coding and Payment – Collaboration Between FDA and the Center for Medicare and Medicaid Services (CMS)
Preeya Noranha Pinto, Partner, King & Spalding LLP

9:20–10:40 AM
Post Marketing Issues
John Constance
, Associate, Shook, Hardy & Bacon LLP
Stephanie S. McGraw, Associate, Shook, Hardy & Bacon LLP

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

10:55 AM–12:00 PM
Enforcement and Compliance
Sonali P. Gunawardhana, Counsel, Shook, Hardy & Bacon LLP

12:00–1:00 PM
Networking Lunch

1:00–2:45 PM
Promotion and Advertising
Danielle C. Humphrey, Counsel, Hogan Lovells US LLP

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

3:00–4:15 PM
Manufacturing and Quality System (QS) Regulation
Allyson B. Mullen
, Associate, Hyman, Phelps & McNamara, PC

4:15–5:00 PM
International Issues
Sarah H. Stec
, Associate, Squire Patton Boggs (US) LLP

5:00 PM
Adjournment

 

 

Overnight Accommodations

A block of rooms has been reserved at the Fairfield Inn and Suites, located in walking distance of the course location.   Reservations can be made online. The group rate is $253/night. Reservations must be received by March 8, 2018 in order to receive the group rate. After this date, rooms will be subject to prevailing rates and availability.

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.

13.0 credits in Virginia
13.5 credits in Pennsylvania & Ohio

Location and Overnight Accommodations

Location

Venable LLP
600 Massachusetts Ave NW
Washington, DC 20001

The course location is within walking distance from the Gallery Place (green, yellow and red lines) and Mt. Vernon Square (green and yellow lines) Metro stations.  Parking is available for $20 per day in the adjacent garage through the entrance on Massachusetts Avenue NW. 

Overnight Accommodations

A block of rooms has been reserved at the Fairfield Inn and Suites, located in walking distance of the course location.   Reservations can be made online. The group rate is $253/night. Reservations must be received by March 8, 2018 in order 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.

2018-04-16T12:31:06+00:00