Guidance for Industry and FDA Staff - Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems

• Date: May 03, 2010
• Source: www.fda.gov

This guidance provides FDA’s current thinking on non-clinical engineering tests that are submitted in investigational device exemption applications (IDEs) and premarket approval applications (PMAs) to support the safety and effectiveness of intravascular stents and their associated delivery systems. This guidance also provides recommendations for labeling for these devices.

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