FDA-Cleared Is Not the Same as FDA-Approved in This Last Week Tonight with John Oliver Clip

This week’s Last Week Tonight with John Oliver takes aim at a topic that is always fun and never gross at all: medical devices. As Oliver explains, these can range from eye contacts to hip replacements. Basically, if it goes in your body, it’s a medical device. And one would think these devices have met the highest standards an American good can, right? The Food and Drug Administration would never let doctors implant products in human bodies without proper human testing. Well …

Medical manufacturers have a loophole that allows products to move into public use without actual human trials. This workaround—known as the 510(K) plan—states that a device can hit the market as long as it is “substantially similar” to a product that has come before it. Intended to prevent stifled innovation within companies, it has become what Oliver describes as “a high-stakes game of telephone.” A device is close enough to its most recent predecessor, but following its family tree leads to decades of minimal testing. A ball-and-joint replacement with a fatal new flaw reaches patients before anyone is even aware.

Even more confusingly, these products that receive a mark stating they are “FDA cleared.” That sounds convincing enough—even doctors are sometimes fooled, Oliver notes. But “cleared” does not mean “approved,” a label meaning said medical device has been strenuously tested.