Updates for 2020

FDLI remains committed to providing high-quality educational programs while keeping our members and event attendees safe during the current pandemic. With this in mind, we are excited to announce that the 2020 Introduction to Medical Device Law and Regulation Course will be a completely virtual event. Please know we are actively exploring options to ensure an engaging and enjoyable experience. Be sure to check the course website regularly for additional announcements and updates.

Overview

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)
  • 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)
  • Food and Drug Administration Amendments Act of 2007 (FDAAA)
  • 21st Century Cures Act (2016)
  • Medical Device User Fee Reauthorization Legislation (including Food and Drug Administration Reauthorization Act of 2017 (FDARA))

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

Register

Industry & Firms

$1199
  • +$400 for non-members

Non-Profit

$799
  • +$200 for non-members

Government

$799
  • +$200 for non-members

Academic

$799
  • +$200 for non-members

Student

$99
  • full-time students only
Register Now

 

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A Valuable Reference In Your Preferred Format

Preorder FDLI’s A Practical Guide to FDA’s Food and Drug Law and Regulation, 7th Edition, now available in e-book and print formats, for an accessible overview to the key legal and regulatory topics.

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.

Previous Agenda

Day 1

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

8:35–9:35 AM
Overview of Medical Device Law and Regulation

9:35–9:50 AM
Break

9:50–11:35 AM
Premarket Notification 510(k) and De Novo Applications

11:35 AM–12:35 PM
Lunch Break

12:35–1:35 PM
Registration and Listing

1:35–2:45 PM
Clinical Investigations: Investigational Device Exemption (IDE), Institutional Review Boards (IRBs), and informed Consent

2:45–3:00 PM
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)

 

 

Day 2

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

8:30–9:30 AM
Manufacturing and Quality System Regulation (QSR)

9:30–10:40 AM
Post Marketing Issues

10:40–10:55 AM
Break

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

12:00–1:00 PM
Lunch Break

1:00–2:30 PM
Promotion and Advertising

2:30–2:45 PM
Break

2:45–4:00 PM
Manufacturing and Quality System (QS) Regulation

4:00–5:00 PM
International Issues

5:00 PM
Adjournment

 

 

Continuing Legal Education

FDLI applies for CLE credits in Ohio 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.