Guidance maps clearance process for trials of knee cartilage products

01/20/2012 | MassDevice.com (Boston)

New guidance from the FDA outlines the process for obtaining clearance for clinical studies of devices, combination products and biologics designed to replace or repair knee cartilage. The guidance requires manufacturers seeking investigational device exemption to submit documents describing materials used, individual elements, anticipated product changes and related data.

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MassDevice.com (Boston)

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