The U.S. Food and Drug Administration (FDA) approval process can be so slow that people die waiting for potentially life-saving drugs and medical devices that are fully developed, but not yet available. One way to get devices to people sooner is the FDA’s post-approval studies program (PAS). It requires far less from device makers before approval, as long as they promise to continue studying the devices after they are approved. It is risky and basically treats patients like guinea pigs, but it is an attempt to find a balance between safety and making devices available more quickly.
Device Makers Do Not Follow Through
Of course, device makers want to get their products to market as soon as possible so they can start racking up the profits, but there are patients who are desperate for new solutions, too. Even if you feel that the trade-off is acceptable, there is another problem. The device makers are not following through with the studies. A recently published study found that, for the 28 high-risk devices approved through the PAS pathway in 2010 and 2011, only 13% of postmarket studies were actually completed.
If the FDA does not enforce its requirement for post-market studies, device makers will continue to take advantage of a system that allows them to avoid costly and time consuming studies, and patients will ultimately pay the price when the devices they depend on fail causing serious injury or killing them.
If you have been harmed by a defective medical device, please talk to an experienced defective medical device attorney right away to learn more about your rights.
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