US bans European bovine material in devices
This article was originally published in Clinica
Executive Summary
US medical devices cannot be made from bovine material originating in western Europe because of the threat of bovine spongiform encephalopathy (BSE), says a new FDA guidance on medical devices containing materials derived from animal sources. In addition, materials from Oman, Albania, Bosnia-Herzegovina, Bulgaria, Croatia, the Czech and Slovak Republics, Hungary, Poland, Romania and Slovenia are also banned.