Explore the impacts of device recalls and safety alerts on clinical trials, and how proactive development of a risk management plan can help minimize confusion and negative consequences. Learn about Unexpected Adverse Device Effects reporting requirements to FDA, investigators, and IRBs. Understand the process of determining the need for a device recall and the steps involved in issuing a recall or safety alert. The speaker will discuss personal experiences and examples of device recalls, safety alerts, and the anticipated impact Unique Device Identification. Gain specific guidance on how to develop a plan for responding to implantable device recalls and alerts from a clinical trial management perspective. This session is a two-part "master series" program.
Identify at least two potential impacts of a device recall or safety alert in a clinical trial
Develop impact assessment tools for their clinical trials when faced with a device recall or safety alert
List at least three components of a medical device recall / safety alert management plan, including UDI implications