NY Times Editorial Focuses on Failures in Medical Device Regulation

A recent New York Times Sunday editorial focused on the deplorable state of medical device regulation. We simply can no longer trust FDA clearances, particularly 510ks:

"Regulatory loopholes — some of which date to the dawn of device regulation and were not meant to be permanent — enable companies to bring new or “update"d” medical devices to market without testing them in human trials first. Companies need only to convince regulators that their products are similar to ones that are already approved, even if the other products are decades old or were subsequently pulled from the market. Eight years ago the Institute of Medicine advised the F.D.A. to abolish at least one of these loopholes, what’s known as the 510(k) pathway. It’s past time for the agency to heed that advice, and to ensure that no medical device intended for permanent residence inside a human body is used on patients without first being rigorously tested."

There's a balance that needs to be struck between speed to market and safety of the public. Right now the regulations are tipped too heavily in favor of the corporations.

https://www.nytimes.com/2019/05/04/opinion/sunday/medical-devices.html