Even with an ideal design and production process, medical devices can begin to exhibit unintended effects once they are on the market. Companies need to be prepared to take the necessary steps to prevent patient harm from these complications. However, as evidenced by the volume of 483 and Warning Letter violations they account for, product recalls, corrections, and removals, as well as their accompanying Part 806 reports, continue to be a source of confusion for medical device companies. In this webinar, long-time FDA veteran and esteemed regulatory consultant, Steven Niedelman, explains how to get it right.
