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Guidance on Knee Cartilage Repair Products

01/18/2012

Federal Register Notice: FDA is making available Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage. It provides IDE and IND sponsors recommendations about information that should be included in a submission for a product intended to repair or replace knee cartilage. The guidance does not apply to prostheses such as unicondylar or total knee implants, or meniscus replacement products. The document also finalizes the draft guidance of the same title dated 7/2007. To view this notice, click here.

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