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Ivy Sports Medicine, LLC v. Sylvia Mathews Burwell, et al
Case Number:
13-5139
Court:
Nature of Suit:
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September 26, 2014
DC Circ. Knocks FDA's Backtrack On Knee Implant Approval
The D.C. Circuit ruled Friday that the U.S. Food & Drug Administration didn't follow the proper procedure to revoke marketing clearance for a knee implant more than two years after it had initially granted it, finding the agency's inherent authority cannot trump Congress's rules for reclassifying medical devices.
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April 08, 2014
FDA Ignored Device Reclassification Process, DC Circ. Told
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.