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FDA medical device approval process under fire

On Behalf of | Aug 1, 2011 | Dangerous Or Defective Products

A series of high profile recalls led the Food and Drug Administration (FDA) to seek recommendations for how the medical device approval system could be improved. Recently, defective product recalls involving Medtronic defibrillators and DuPuy artificial hips have drawn significant attention to how the FDA grants approval for medical devices. These and many other medical devices were approved under a fast-track process known as 510(k). According to at least one group, the process is inherently flawed.

The institute of Medicine (IOM) released a report claiming the fast-track process fails to properly protect patients. They concluded that the process should be scrapped and replaced with an entirely different regulatory framework. The FDA and the manufacturers of medical devices were quick to label this proposal as reactionary. They believe that the problems can be addressed under the basic guidelines of the 510(k) process.

Much of the concern stems from an aspect of the fast-track process that allows medical devices to be used on patients more quickly if the device is similar to existing devices. Roughly 4,000 devices were approved in 2009 under this provision. While that provision is popular among medical device manufacturers, it does not go far enough to protect patients in the view of the IOM.

Victims of defective medical devices must be able to protect their rights. Defective devices are a threat to the public and will continue to cause injury and death as long as they are on the market. By pursuing legal action, victims of defective products can help the FDA identify malfunctioning devices and issue recalls to protect others from harm.

Source:, “U.S. advisers call for overhaul of FDA device approval process,” Andrew Seaman, 29 July, 2011