FDA Issues Guidance On IDEs For Knee Cartilage Replacement
By
Sue Darcey / Email the Author / “The Gray Sheet” Jul. 16, 2007, Vol. 33, No. 029
Regulatory / Word Count: 608 / Article # 01330290010
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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