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FDA Will Define Preclinical Testing Requirements For Drug-Coated Stents

This article was originally published in The Gray Sheet

Executive Summary

Preclinical data requirements for drug-eluting stent sponsors will be addressed in a forthcoming FDA guidance. Items to be covered include material analysis, integrity and fatigue testing, stent/catheter system testing, and animal testing, according to Center for Devices and Radiological Health reviewers.
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