Bankrupt medical device maker ReGen Biologics Inc. has sued the Food and Drug Administration, claiming that the agency overstepped its authority when it reclassified the company’s knee implant and forced it off the market.
Such a reclassification is unprecedented, and ReGen argues the FDA has no right to do it. But FDA officials have faulted their predecessors for greenlighting ReGen’s device in the first place, saying the review process was wrongly influenced by lobbying and intense Congressional scrutiny.
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