FDA Clamps Down on Medical Device Makers

The Food and Drug Administration is asking several medical device makers, including Zimmer Holdings, Inc. and Medtronic to justify their devices’ safety and effectiveness. This comes in spite of the fact that many of the medical devices are already on the market. Zimmer’s Durom Cup hip implant has faced major scrutiny for defective design.
Of course, the medical device companies are trying to avoid further clinical trials of their products by persuading the federal agency to re-classify them as less risky medical devices.
The controversy stems from a 1990 Congressional order that demanded the FDA to collect sound scientific evidence that the medical devices classified as Class III (most risky) were indeed safe. The problem is that the law was never fully implemented by the FDA. Instead, many medical devices that should have been bound by the Congressional order, received what is known as a 510(k) classification. This “exemption” allowed hundreds of Class III medical devices to be sold in spite of the lack of clinical testing required by law.
In the meantime, consumers remain at risk from these medical devices that have been allowed to slip through the bureaucratic cracks of the FDA. Medical device manufacturers win since they’re can continue to sell products that may in fact be dangerous to consumers and have not been bound to the rigorous and extensive clinical testing required by a Class III categorization.