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Zdrowie i gospodarka · 30.08.2013

Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Select Updates for Non- Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems." 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 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), we are issuing this update on select sections in order to notify the industry in a timely manner of our revised recommendations. This draft guidance is not final nor is it in effect at this time.

Source: Federal Register — Food and Drug AdministrationOpen original release →