Most medical devices have never been shown to be safe or effective. The US Food and Drug Administration have promised for years to subject some of the riskiest devices to a rigorous review.
The agency has failed to adequately regulate medical devices leaving certain types of devices already on the market approved for sale with less stringent reviews until the F.D.A. would require them to pass a more rigorous test. Consumers responded that the agency was failing to protect the public, and the industry groups acknowledged that the system was flawed in many different areas.
The agency has turned a blind eye to many medical devices, by ignoring the statue and failing to reclassify them. There is no question that the F.D.A. needs to fix its reclassification process asap.