ReGen sues US FDA for "unlawful" revoking of Menaflex clearance
This article was originally published in SRA
Executive Summary
ReGen Biologics has filed a lawsuit against the US Food and Drug Administration, contending that the agency's rescission of the 510(k) clearance of its Menaflex collagen meniscus implant was "unlawful, arbitrary and capricious"1,2.
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