FDA issues draft guidelines for drug-eluting stents
The potential increased risk of thrombosis associated with the implantation of drug-eluting stents (DES) has led the FDA to issue a draft guidance to aid in the development, testing, and manufacture of the devices. According to the agency, the new document outlines recommendations that could provide data that will help address potential safety concerns. The guidance contains expertise from two FDA centers-the Center for Devices & Radiological Health and the Center for Drug Evaluation & Research-and highlights the information necessary for a complete marketing submission. In addition, the document provides guidance on assessing the toxicity of the drug used to coat the stent, both on its own and as part of the final product, and the types of tests necessary to assess the device?s overall safety. A copy of the guidance, "Draft Guidance for Industry on Developing Coronary Drug Eluting Stents," can be found Federal Register and on the FDA comment on the draft guidance will be accepted for 120 days.