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FDA Issues Guidance On IDEs For Knee Cartilage Replacement

This article was originally published in The Gray Sheet

Executive Summary

Investigational device exemption (IDE) applications for knee cartilage replacement products should include a detailed product description, manufacturing and packaging methodology, and nonclinical testing data to assess biological responses and toxicology, FDA advises in a July 9 1draft guidance

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Pain And Function Are Best Endpoints For Knee Cartilage Trials – FDA Panel

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