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Expert Analysis

FDA Deviations In Menaflex Knee Device Clearance

Law360 (October 5, 2009, 1:46 PM EDT) -- In an unusual "preliminary report" released recently, the U.S. Food and Drug Administration admitted to "multiple departures from processes, procedures and practices" in the 510(k) clearance of ReGen Biologics' Menaflex knee repair implant, which "leave[s] the basis for a review decision in question."...

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