FDA Ignored Device Reclassification Process, DC Circ. Told
By Erica Teichert
Law360, Washington (April 8, 2014, 3:23 PM EDT) -- ReGen Biologics Inc. urged a D.C. Circuit panel on Tuesday to nix a U.S. Food and Drug Administration decision reclassifying its knee implant device as not being substantially similar to others on the market, an action the company claims drove it into bankruptcy, saying the agency should have undergone a full notice and comment process to reach that conclusion.
According to ReGen, the FDA ignored its congressionally mandated device reclassification procedures when it revoked its initial determination that the collagen meniscus implant at issue was substantially...