Keith J. Winstein, Wall Street Journal 3/15/07 (Subscription Only) - Reports on Biliary-Stents
March 22, 2007 18:31

FDA Contests Biliary-Stent Marketing: "Food and Drug Administration staffers warned makers of bile-duct stents that the agency believes a number of them may be promoting the devices for unapproved vascular uses. At a Monday meeting in Washington with 10 to 20 stent makers, FDA staffers, including the head of its medical-devices unit, instructed manufacturers to detail how they would rein in their sales staffs, according to several people familiar with the matter. The agency displayed manufacturers' Web sites that it said crossed the line into unauthorized territory. It is illegal to market devices for uses other than those for which they were approved."