The number of medical device recalls has been climbing steadily—from just over 2,300 in 2013 to more than 3,200 in 2017. But not all recalls are created equally. A voluntary manufacturer recall has far different ramifications, both fiscally and socially, than a forced recall by the U.S. Food and Drug Administration (FDA). Whether your recall is Class I, Class II, or Class III, you need to understand the process completely and know what proactive steps you can take.
Angela Bazigos has more than 40 years of experience in the medical industry: She’s worked on quality assurance, regulatory compliance, project management, and clinical lab science. Join her for this in-depth virtual boot camp to examine FDA’s medical device recall policy. Learn how to determine if you are affected, what your firm’s responsibilities and action points are, what exceptions there are to the FDA process, and what sort of enforcement action you can expect.
After attending this event, you will know how to create a communication and recall strategy, what you need to follow up on, how to obtain recall status reports, and what factors to consider when recalling a device. You will also fully understand FDA’s enforcement policy, expectations, recall classification, and recall termination status. Learn all the ins and outs of this process before the FDA comes calling!Session Highlights
Here is a taste of what you will uncover: