Introduction to Medical Device Recalls: Industry Responsibilities
This presentation is an overview of Industry Responsibilities and the FDA’s role in the recall process of a medical device. The purpose of this presentation is to explain to Industry what their role and responsibilities are in a Medical Device Recall. The presentation discusses the basics of a recall, how to determine and initiate a medical device recall and how to report a medical device recall. It also covered the responsibilities and requirements of the recalling firm and the FDA, and finally the FDA’s overall role in a medical device recall.