Fast-Track Approval of Medical Devices Called into Question
The United States is the largest medical device market in the world with sales expected to reach $133 billion by 2016. In most cases, medical devices save and improve lives. Unfortunately, not all devices undergo the same rigorous review process before hitting the market. A number of new medical devices can and do bypass scrutiny by the U.S. Food and Drug Administration (FDA) through a fast-track approval process called the 510(k) program. If a manufacturer…