FDA reconsidering approval of ReGen knee device
The FDA is reconsidering the approval of ReGen Biologics Inc’s knee device after an investigation showed that unprecedented industry and Congressional involvement influenced the agency’s decision. Joshua Sharfstein, the agency’s principal deputy commissioner, said, however, that patients who have had Menaflex implanted in their knee need not panic and noted that the device is still on the market. ReGen Chief Executive Gerald Bisbee said in a statement that the report didn’t evaluate the scientific evidence about the device. The company said the product is safe and helps knee-surgery patients recover more quickly.
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