If medical device companies are going to use the 510(k) expedited regulatory process, they should have a greater responsibility to make sure the product they take to market is safe since it did not go through normal safety channels. Medical device companies stand to make a substantial profit off of devices like vaginal mesh kits that went through the expedited regulatory process. It is not unfair to expect these same companies to be responsible for the monitoring of these devices as they make their way through market and, subsequently, be held responsible if the device is later found to cause the injury.
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