Course offering number:0907-707
Course ID:
2316
Failure to Warn and Medical Device Preemption
Pre-recorded Course
AN ON-DEMAND ONLINE TRAINING FORMAT
Who Should Attend
This course is a must for anyone in the medical device regulatory field including personal in the following positions:
• Quality Assurance and Control
• Regulatory Affairs
• Medical Device Representatives and Managers
• Sales Personnel
• Manufacturers
• Physicians
• Pharmacists
• Health Care Providers and Practitioners
• Attorneys
• In House Counsel
• Risk Managers
• Enforcement Personnel
Description
The duty of the health care provider, medical device manufacturer and pharmacist to warn has become more and more important and
complicated especially with the United States Supreme Court landmark decision of Riegel v. Medtronic. This 90-minute accredited online
program offers the opportunity for participants to learn the latest about legislative initiatives. The Duty to Warn will be analyzed. The course will
include a case study demonstrating a lawsuit brought against a medical device manufacturer for the failure to warn.
Module 1:
• What is Preemption?
• How does the Preemption Doctrine apply to Medical
Devices?
Module 2:
• Who has a specific duty to warn – Health care provider or
medical device manufacturer?
• Update on Legislative Initiatives
Module 3:
• What are the ethical considerations involved?
• Case study
Questions and Answer Session