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Medical devices are necessary to the survival of many patients throughout the U.S. Unfortunately, a mistake or oversight in the design, marketing or manufacturing process can lead to catastrophic injury. Some examples of common mistakes leading to physical injuries include metal-on-metal hip replacement device failures and negative side effects of IVC filters.
Medical Device Failures Medical devices must be approved by FDA prior to use by doctors. What most people don’t realize, however, is that there are two methods of approval: pre-market approval (PMA) and “510(k)” approval, and they are very different.
With PMA approval, the manufacturer must submit a lengthy application to FDA, which details the design and clinical-test results of the product. The PMA approval process weighs the benefits of the device with the risks of using it. The manufacturer of the new device must strictly comply with any approval including the approved design, marketing, and manufacturing process.
With a 510(k) clearance, however, the manufacturer must merely show that the new device is substantially similar to a product that previously received PMA approval by FDA. Unbeknownst to patients, with a 510(k) approval, no testing is required by the manufacturer or FDA prior to the device being implanted in them. Companies strive to use this much easier (and less safe) pathway to FDA approval so they can get new products to the marketplace faster.
Whether the problem can be traced back to the design, manufacturing, or labeling of the product, our team will work to investigate every avenue of compensation available to you and your loved ones. Our attorneys are nationally-recognized for their work in record-setting and otherwise large cases. Together, they bring over half a century of legal experience to the table and are passionate about holding large medical device manufacturers responsible for the injuries they have caused.
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