FDA Approval Of Medical Devices Involves Shockingly Little Research

Are federal regulators playing fast and loose with the health of the tens of millions of Americans who rely on medical devices to see, walk and survive?

That’s the suggestion of a new study that finds most medical devices go to market with little evidence that they work or are safe.

Groups like Consumer Reports and the Government Accountability Office have long criticized the U.S. Food and Drug Administration for approving medical devices that end up killing thousands of people a year. They’ve been most critical of the fact that the FDA allows 99 percent of new devices to go to market without any new clinical testing whatsoever.

But a team at the Yale School of Medicine found that even the 1 percent of devices that are studied before getting FDA approval likely aren’t being studied enough.

This 1 percent consists of so-called “high-risk” devices, which are very different from any others on the market and which are implanted within the body or directly support human life. The Yale researchers found that these devices are subjected to an average of just one major study apiece before being granted FDA approval. This means that doctors are implanting devices like coronary stents, replacement hips and intraocular lenses in thousands of patients after they’ve been tested on groups of just a couple hundred people each.

Dr. Joseph Ross, a professor at Yale School of Medicine and one of the authors of the paper, said that this state of affairs is the result of federal legislation stipulating that the FDA can only require manufacturers to do the bare minimum amount of research to demonstrate the efficacy and safety of a new medical device.

“The laws are written in a way to facilitate earlier access to therapy, because —> Read More