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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

FDA stent guidance: Agency releases 1guidance April 30 on non-clinical engineering tests and recommended labeling for intravascular stents and stent delivery systems. The document suggests what test data should be included and how data should be formatted. For example, the guidance makes testing recommendations regarding material composition, fatigue/durability, MRI safety and compatibility, crush and kink resistance, shelf-life and biocompatibility. The guidance covers self-expanding and balloon expandable stents used in coronary and peripheral arteries, as well as stents for other vascular indications; non-vascular stents and stents used in the intracranial vasculature are outside the scope of the guidance. Some of the recommendations are relevant to drug-eluting and biodegradable stents, but additional recommended tests for these devices are outlined in drug-eluting stent draft guidance, FDA notes. The document supersedes January 2005 guidance

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