<i>How I See It: </i>Uncertainty in medical device industry
A recent development signals the U.S. Food and Drug Administration intends to broaden its regulatory powers, leaving companies in the medical device industry and those that invest in development of medical technologies in a state of uncertainty.
The FDA announced its intention to rescind a 510(k) medical device registration held by ReGen Biologics Inc., for the company’s Menaflex collagen scaffold. The FDA granted marketing approval for the product in 2008. However, on Oct. 14, 2010, the FDA notified the company that it intended to rescind prior clearance, stating, “The FDA has now concluded that the Menaflex device is intended to be used for different purposes and is technologically dissimilar from devices already on the market” and that “these differences can affect the safety and effectiveness of the Menaflex device. For example, instead of simply repairing or reinforcing damaged tissue like predicate devices, Menaflex is intended to stimulate the growth of new tissue to replace tissue that was surgically removed. Because of these differences, the Menaflex device should not have been cleared by the agency.”