After numerous news releases and reports of pending lawsuits regarding metal hip implants, the FDA is taking action to require additional safeguards and testing before such products are put on the market. The problematic hip joint implants have involved major corporations such as Johnson & Johnson, Zimmer Holdings, and Smith & Nephew, PLC. Along with the hip implant devices, the FDA is doing an extensive evaluation of various medical devices that have known defects, such as electroconvulsive therapy devices for depression and emergency defibrillators. All of the products subject to the new evaluation were approved under the FDA’s shortcut approval process known as 510K. This process requires only that the company prove that their new product is “basically equivalent” to another product already on the market. The FDA is now acknowledging that there are some products, including metal hip implants, which should require extensive clinical studies and should not be allowed to go through the expedited approval process. As is evident from the severe defects in these products, the product manufacturers should have to provide thorough scientific evidence and testing results to the FDA before the products are accessible to the public.
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