A small medical device maker whose knee implant was cleared by the
US Food and Drug Administration (FDA) only to have that clearance later
revoked has filed suit against the agency. New Jersey-based ReGen
Biologics filed the lawsuit this week in the US District Court for the
District of Columbia, calling FDA's rescission of its original 510(k)
clearance of the company’s Menaflex Collagen Meniscus Implant unlawful,
arbitrary and capricious. FDA cleared the device in 2008, despite
reported objections from FDA scientists. Officials reviewing the
original decision later found that lobbying by four New Jersey
congressmen and ex-FDA Commissioner Andrew von Eschenbach had influenced
the agency’s decision to clear the device.
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