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Guidance on Tests/Labeling for Intravascular Stents
08/18/2015
 

Federal Register Notice: FDA is making available a guidance: 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 FDA’s thinking on certain non-clinical testing for these devices. While FDA is considering more substantial updates to the “Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems” guidance (http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm071863.htm), it is issuing this update on select sections in order to notify the industry in a timely manner of our revised recommendations. To download this guidance, click here. To view this notice, click here.

 
 
 
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