Examining The Scope Of FDA's 510(k) Recission Authority

Law360, New York (June 20, 2013, 2:58 PM EDT) -- The United States District Court for the District of Columbia issued an opinion in Ivy Sports Medicine LLC v. Sebelius, a lawsuit filed in May 2011 by ReGen Biologics Inc. (“ReGen”) against the U.S. Food and Drug Administration and decided on April 10, 2013. (Ivy Sports Medicine acquired ReGen in June 2011.)

The recent ruling is the latest event in ReGen’s attempt to reinstate the Dec. 18, 2008, 510(k) clearance for its Menaflex collagen scaffold device that the FDA rescinded on March 30, 2011. Although the...
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