Friday, March 4, 2011

DePuy ASR Hip Implant Recall And The FDA Approval Process Reviewed

 A study published in the Archives of Internal Medicine,  suggests that most medical devices recalled for life-threatening or very serious hazards were cleared by the Food and Drug Administration through an expedited review process called 510(k), or were considered so "low risk" they were exempt from review entirely

Dr. Steven Nissen and his colleagues examined the number of medical device recalls between 2005 and 2009 and determined which regulatory pathway they had taken -- 510(k) or the more rigorous premarket approval process.  Out of 113 recalls of devices determined by the FDA to cause serious health problems or death, 80 were cleared through 510(k). Another eight were exempt from FDA regulation. If a device is shown to be substantially similar to one already on the market, the 510(k) pathway allows its makers to bypass the PMA pathway's rigorous preclinical testing and inspections.
In fact, according to Dr. Nissen, "Some 80 percent or so of devices being recalled were actually never fully clinically tested in people."

FDA’s ReactionIn September 2009, the FDA asked the Institute of Medicine to review the 510(k) process. The FDA then simultaneously established two internal committees to make recommendations for making the system better. The internal committees suggested 55 changes to the process in August 2010, but a plan announced in January only had 25 of those changes

The FDA isn’t conceding that Nissen’s study reveals a problem with the review system.
"The devices that were evaluated via this program, over 19,000 of them serve the American public very well and they're safe. There are some occasional devices, for which we issue recalls or advisories. And that's appropriate," an FDA spokesperson said.

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