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

Abstract

In the past, some medical device manufacturers were obtaining marketing clearance for metallic stents indicated for biliary use; however, these devices were being promoted and used in the peripheral vasculature, creating a patient safety problem. The US Food and Drug Administration (FDA) acted in 2006-2008 to help decrease off-label use of metal expandable biliary stents. This communication describes the early and continued efforts of the FDA to address safety concerns relating to off-label use