ReGen Biologics, Inc. Receives 'Not Substantially Equivalent (NSE)' Letter from FDA for Collagen Scaffold device

HACKENSACK, N.J.--(BUSINESS WIRE)--ReGen Biologics, Inc. (OTC: RGBI) announced today that the company is in receipt of a not substantially equivalent (NSE) letter from the U.S. Food and Drug Administration (FDA) regarding the 510(k) submission for its Collagen Scaffold device. The FDA indicated the device is not substantially equivalent to existing Class II devices already in receipt of FDA clearance. ReGen filed the 510(k) submission in late 2006 based on guidance received from FDA following the Company’s appeal of an original NSE decision based on the Company’s initial 510(k) submission in December 2005.

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