Medical Implants Are Bypassing FDA Approval By Using 1970's Loophole

A lot of folks are under the mistaken belief that for a device to be able to be implanted in a human body in the United States, it has to be approved by the FDA. That's simply not the case and there's this weird process called a 510(k). There are no clinical testing requirements and there is no requirement that the device be tested for safety or efficacy as long as it's substantially equivalent to a device that was already on the market, even if it piggybacked off of a device that was recalled.