Thursday, February 21, 2013

U.S. FDA Clamps Down on Metal-on-Metal Hips, Proposes Highest Risk Classification

2/20/13 from the FDA

Manufacturers of metal-on-metal (MoM) hip implants will need to file premarket approval (PMA) applications proving the devices are safe and effective in humans, under a proposed order published by the U.S. Food and Drug Administration (FDA). The proposal — which applies both to MoM hips that include a cemented acetabular component and those that do not — would move the devices from Class II to Class III and require companies with products already on the market to go back and obtain premarket approval. The agency also issued a stronger patient safety warning on the hips.

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