Court Rules that FDA has the Inherent Authority to Rescind a 510(k) Substantial Equivalence Determination if It Does so Within a Reasonable Period of Time
ReGen Biologics, Inc. (“ReGen”), which has been acquired by Ivy Sports Medicine, LLC (“Ivy”), filed suit in 2011 challenging FDA’s authority to rescind the 2008 510(k) substantial equivalence determination for the company’s “Menaflex” product, a collagen meniscus implant intended to reinforce damaged meniscal soft tissue. ReGen Biologics, Inc. v. Sebelius, No. 1:11-cv-01006 (D.D.C. filed May 31, 2011).