FDA Deviations In Menaflex Knee Device Clearance

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Law360, New York (October 05, 2009) -- 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.”

The report, authored by FDA Acting Chief Counsel Michael Landa, Acting Chief Scientist Jesse Goodman and Associate Commissioner for Policy and Planning Jeffrey Shuren, recommends an independent science-based reevaluation of the Menaflex 510(k) clearance decision.

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