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Category: Defective Medical Devices

High Risk Devices Still Not Reclassified

12/13/2012
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By the end of the year, the U.S. Food and Drug Administration (FDA) had stated it would make sure that high-risk medical devices were approved through the most stringent premarket approval (PMA) review process to assure the safety of consumers. But it looks as though that will not happen. High-risk […]

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Medical Regulators in EU Allows Bogus Hip to Market

11/14/2012
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There are about 70 notifying bodies scattered around Europe that are in charge of deciding whether or not a medical device can be sold in that respective country. It is their alternative to the U.S. Food and Drug Administration (FDA), which is considered more rigorous in ensuring patient safety. Or […]

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