FDA Issues Draft Guidelines on Drug-Eluting Stents
Safety aspects of development, testing and manufacture of devices covered
THURSDAY, March 27 (HealthDay News) -- The U.S. Food and Drug Administration has issued a set of draft guidelines on drug-eluting stents, used in two-thirds of U.S. patients surgically treated for coronary atherosclerosis.
So far, three drug-eluting stents have attained FDA approval, and 650,000 of the one million U.S. patients who undergo surgery for coronary atherosclerosis are treated with them each year. The new FDA guidance document provides manufacturers with recommendations on pre-market clinical evaluation and post-market studies that can address concerns about clot formation in patients after treatment with drug-eluting stents, as well as other safety concerns.
The guidance notes also recommend what information is necessary in a marketing submission for a drug-eluting stent and gives guidance on assessing toxicity of the drug used. The document has drawn on the expertise of two FDA centers: the Center for Devices and Radiological Health and the Center for Drug Evaluation and Research.
"This guidance demonstrates how FDA will need to work across traditional product boundaries to guide the development of innovative new products," said Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research, in a statement.