U.S. Food and Drug Administration and Off-Label Use of Expandable Metal Biliary Stents within the Peripheral Vasculature

Expandable metal stents are used to maintain the patency of compromised ducts, lumens, and vessels. As medical devices, these products are regulated by the Center for Devices and Radiological Health of the U.S. Food and Drug Administration (FDA). During the past several years, the FDA has become aware of the increasing prevalence of off-label use of expandable metal stents cleared for biliary use within the peripheral vasculature. The authors provide an overview of how the FDA regulates medical devices and expandable stents and summarize safety issues reported to the Agency with regard to the off-label use of these biliary stents.