Minneapolis mass tort and complex litigation attorney Bucky Zimmerman discusses the regulation of medical devices.
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They’re regulated by the FDA through and approval process and what people don’t really understand about the FDA is they don’t do any scientific testing they review testing and scientific data from the companies. The review the data and then they pass or don’t pass on the approvals, but what they don’t do is their own testing. And so the FDA is simply being told what the device can and cannot do and what the science may or may not show and sometimes they’re wrong. Sometimes the science comes out later to show that the device really didn’t perform the way it was supposed to and that’s when they issue the recall. But what they don’t do is test, monitor and test in the way some people think that they do. It’s really up to the company.