This intensive introductory course provides a thorough overview of the legal framework for medical devices. Attendees will gain a comprehensive understanding of the Food and Drug Administration’s (FDA) medical device regulatory and approval process.


Coming soon.

Draft Agenda

Introduction to Medical Device Law and Regulation Course:
The Legal Framework for Medical Device Regulation

*Agenda subject to change

Day 1

8:00 AM
Registration and Continental Breakfast

8:30 AM
FDLI Welcome and Announcements

8:35 – 10:00 AM
Overview of Medical Device Law and Regulation

  • Review the statutory framework of how the government regulates the medical device industry
  • Define “device” and differentiate between the medical device classes
  • Explore the nuances of combination products
  • Examine the purpose and outcome of medical device user fees

10:00 – 10:15 AM
Organizational Structures

  • Review the government organizational structure, their respective roles and jurisdiction, and communications

10:15 – 10:40 AM
Networking and Refreshment Break

10:40 AM – 12:05 PM
Premarket Notification (510(k))

  • Examine the legal basis and content for a 510(k)
  • Define Substantial Equivalence
  • Obtain updated information on the 510(k) Working Group, the Institute of Medicine Study and the future of 510(k)s
  • Assess 501(k) case study

12:05 – 1:30 PM
Networking Lunch

1:30 – 2:00 PM
Registration and Listing

  • Define Registration and Listing and their applications to the medical device industry
  • Describe who must and who does not have to register and list

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

  • Review the definition of Investigational Device Exemption
  • Determine when an IDE is needed
  • Examine the components of Institutional Review Boards and the elements of Informed Consent

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

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

  • Identify the responsibilities of clinical trials sponsors and investigators
  • Recognize examples of Adverse Event Reporting (AER)
  • Become familiar with the purposes of Bioresearch Monitoring (BIMO)

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

  • Review the legal basis and content of a Premarket Approval Application
  • Differentiate between a 510(k) and a PMA
  • Define Humanitarian Device Exemption

5:00 – 6:00 PM
Networking Reception

Day 2

8:00 AM
Continental Breakfast

8:30 – 8:35 AM
FDLI Announcements

8:35 – 9:20 AM
Coverage, Coding and Payment – Collaboration Between FDA and the Centers for Medicare and Medicaid Services (CMS)

  • Gain a clearer context of the Centers for Medicare and Medicaid Services relationship with FDA – reimbursement and approval
  • Distinguish the data needs of CMS from FDA

9:20 – 10:40 AM
Post Marketing Issues

  • Review the definitions and purposes of Complaint Handling, Medical Device Reporting, Recalls, Corrections and Removals, Safety Alerts and Ongoing Monitoring/ Postmarket Surveillance
  • Examine risk communication initiatives

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

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

  • Explore FDA’s enforcement jurisdiction and the 2009 Enforcement Initiatives
  • Review the various prohibited acts and penalties
  • Discuss FDA’s inspection scope and use of enforcement tools

12:00 – 1:00 PM
Networking Lunch

1:00 – 2:15 PM
Promotion and Advertising

  • Review the scope of FDA authority concerning medical device promotion and advertising
  • Define “label” and “labeling” and “false and “misleading”
  • Discuss off-label issues, claims substantiation and Direct-to-Consumer (DTC) Advertising

2:15 – 2:45 PM
Hypothetical/Case Study

  • Working in small groups and using knowledge obtained during the course, participants will identify and address regulatory issues during this problem-solving exercise.

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

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

  • Explore the background, purpose and regulatory requirements of the Quality System Regulation
  • Become familiar with the components and definitions associated with the QSR History, Purpose and Scope
  • Differentiate the International Standards Organization (ISO) from the QSR

4:15 – 5:00 PM
International Issues

  • Examine the legal framework concerning imports and exports of medical devices
  • Review the basis of unapproved devices

5:00 PM

Speaker Biographies

Coming soon.

Onsite Materials

Coming soon.

Continuing Legal Education

Continuing Legal Education credits will be awarded for attending this program.

FDLI applies directly to Ohio, Pennsylvania, and Virginia. New York recognizes Pennsylvania approvals. These states are generally recognized as approved jurisdictions by other states, however, each state bar has its own requirements, and it is the responsibility of the attorney seeking CLEs to know and fulfill such requirements.  Please contact your Bar Association for guidance.

Virginia, Pennsylvania, and Ohio approvals are pending.

FDLI applies for CLE credits prior to each meeting but sometimes the approval is not granted until after the meeting. As approvals are received, updated CLE information will be posted here, and you can request to be notified.

Location and Overnight Accommodations

Coming soon.