FDA Ignored Device Reclassification Process, DC Circ. Told

FDA Ignored Device Reclassification Process, DC Circ. Told

ReGen Biologics Inc. urged a D.C. Circuit panel on Tuesday to nix an 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 ...read more

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