FDA To Beef Up DES Testing Requirements

FDA will issue new, more stringent testing guidelines for drug-eluting stents, CDRH Director Daniel Schultz told the Wall Street Journal. The guidelines are expected to cover things like how many patients should be involved in premarket and postmarket studies, and how long the studies should go. They could also recommend how long patients should stay on anti-clotting drugs after implantation. Expect DES studies to get even more costly than they already are.