Food and Drug Administration has ordered all producers of “metal-on-metal” artificial hips to commence studies of the implants, which have been linked to high early failure rates.  The order was directed to 21 manufacturers of “metal-on-metal” hip devices.  Manufacturers will be required to submit a research protocol to the FDA that addresses specific safety issues related to these devices. Data from the studies conducted will enable the FDA to better understand these devices and their

The New England Journal of Medicine reports that at an April 13, 2011 hearing before the Senate Special Committee on Aging focused on a Government Accountability Office report identifying safety concerns about the FDA’s process for approving medical devices. According to the report, the FDA has reclassified only 1 of 27 types of high-risk devices that, in 2009, could still enter the market through the less stringent 510(k) process instead of being submitted to the