Once a medical device is brought to market, FDA surveillance of its safety continues. “To facilitate incremental improvements in safety and effectiveness, the FDA allows manufacturers to modify ...

In 2016, medical device giant Abbott issued a recall for its MitraClip cardiac device — "a Class I recall, the most serious type," the FDA said. "Use of this device may cause serious injuries or death ...

Among the products subject to litigation for alleged damages are those regulated by FDA. From one perspective, FDA regulation can provide a defense against the possibility of recovery for damages ...