FDA To Rescind A 510(k): Rare Action Targets ReGen's Menaflex Device

Article preview from "The Gray Sheet" - October 18, 2010

FDA says it will seek to rescind a much-scrutinized 510(k) clearance of an implantable knee device, initiating a rarely used regulatory authority that some in industry argue does not exist.

FDA To Rescind A 510(k): Rare Action Targets ReGen's Menaflex Device

Article preview from "The Gray Sheet" - October 18, 2010

The agency announced Oct. 14 that after a yearlong reevaluation, it has decided that its December 2008 clearance of ReGen Biologics' Menaflex collagen scaffold for repairing and reinforcing knee meniscal tissue should not have happened.

Specifically, FDA now says that the device "is intended to be used for different purposes and is technologically dissimilar from devices already on the market, called 'predicate devices.'"

The original Menaflex review process, which included two findings of "not substantially equivalent" prior to the 2008 clearance decision, was fraught with internal FDA disputes and marred by public charges that political pressure drove the final decision. (See " Device Center Discord: 510(k) Review Process Is Flash Point At CDRH " - "The Gray Sheet" March 16, 2009.)

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