A guidance has been posted titled, “Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems - Guidance for Industry and Food and Drug Administration Staff."
FDA has developed this guidance to inform the coronary and peripheral stent industry about selected updates to FDA’s thinking regarding certain non-clinical testing for these devices. While FDA is in the process of making more substantial updates to the Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems guidance, we are issuing this guidance update on select sections in order to notify the industry in a timely manner of our revised recommendations.
To view the Guidance, please see:
MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/UCM458490. pdf.