Executive Summary
The Food and Drug Administration (FDA) is tasked with the job of ensuring that all products produced within medical device, food and beverage, pharmaceuticals, biologics, and all other industries encompassed within the food and drug arena are produced safely and effectively. The FDA receives more than 400,000 reports on adverse events each year. In order to give each of these events the individual attention necessary to mitigate risk, the FDA must be properly informed by an organization of all reportable adverse events—and in an industry that produces devices that directly affect human lives, proper collaboration with the FDA is crucial.