FDA News

ReGen Biologics 510(k) to be Considered by FDA Orthopaedic Panel

(Nov 11, 2008)-- ReGen Biologics announced that the Food and Drug Administration ("FDA") has scheduled a meeting of the Orthopaedic and Rehabilitation Devices Advisory Panel ("Orthopaedic Panel") to discuss and make recommendations on the ReGen collagen scaffold 510(k). The meeting is scheduled for November 14, 2008, to be held at the Hilton Washington DC North/Gaithersburg, Salons A, B and C, 620 Perry Parkway, Gaithersburg, MD beginning at 8:00 AM EDT. The meeting is open to the public. The FDA notice is posted at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory /details.cfm?mtg=710.

ReGen submitted its latest collagen scaffold 510(k) in July 2008 for clearance as a class II surgical mesh with an intended use that includes the reinforcement and repair of chronic meniscus injuries. After the meeting, it is expected that the FDA will use input from the Orthopaedic Panel to make a formal clearance decision regarding the ReGen 510(k) submission.

Formore information, please visit http://www.regenbio.com

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