Rottenstein Law Group Encouraged by FDA’s Plan to Tighten Metal-on-Metal Hip Replacement Regulations
After more than 500,000 metal-on-metal hip replacements from companies such as DePuy have experienced early failure, becoming the subjects of hip replacement lawsuits and hip recalls, the U.S. Food and Drug Administration said on Jan. 17 that it would seek to tighten regulations on these devices, according to a New York Times report.
(PRWEB) January 17, 2013
After more than 500,000 metal-on-metal hip replacements from companies such as DePuy have experienced early failure, becoming the subjects of hip replacement lawsuits and hip recalls, the U.S. Food and Drug Administration said on Jan. 17 that it would seek to tighten regulations on these devices, according to a New York Times report.
The Rottenstein Law Group is encouraged by this proposal, which according to the Times [report calls for makers of metal-on-metal hip replacements to prove the safety and efficacy of such devices before they can continue to sell existing ones or obtain approval for new metal-on-metal hip designs.
The new proposal fixes a glaring error in the FDA’s previous approval process, the Times said. The 510(k) process allows companies to gain approval for devices without clinical trials if the devices resemble ones already approved and on the market. This led to approval of several metal-on-metal hip replacement systems because the designs were similar enough to previous ceramic hip implants.
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