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Guidance on Non-Clinical Testing for Intravascular Stents

08/30/2013

Federal Register Notice: FDA is making available a draft guidance entitled Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems. The agency has developed this guidance to inform the coronary and peripheral stent industry about selected updates to its thinking on certain non-clinical testing for these devices. FDA is considering more substantial updates to the Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems guidance and is issuing this update on select sections in order to notify the industry in a timely manner of the revised recommendations. To download this draft guidance, click here. To view this notice, click here.

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