Express preemption and premarket approval under the Medical Device Amendments.

Millions of dollars are spent each year in an effort to develop new medical devices designed to help individuals facing serious medical conditions. However, before these devices can reach consumers, they must be reviewed and cleared by the Food and Drug Administration ("FDA"). Innovative medical devices which pose the greatest risks and are aimed at helping the most critically ill consumers are subjected to intense FDA scrutiny under a process known as pre-market approval ("PMA"). Having undergone an extensive, time-consuming, and expensive pre-market review by the FDA, those devices which meet the FDA's strict requirements may then be offered for sale in the United States.