More than three quarters of medical devices recalled by the Food and Drug Administration for life-threatening or very serious hazards were approved through an expedited process or were classified as exempt from review, according to a study published online in the Archives of Internal Medicine.
Quick approvals tied to device recalls: study
Led by Diana Zuckerman, president of the Washington-based National Research Center for Women & Families, researchers analyzed five years of high-risk device recalls from the FDA to determine what level of approval process had been used.
Of the 113 devices recalled from 2005 to 2009 because the agency said they could cause serious harm or death, 71% were approved through the 510(k) process—an expedited process for devices that are viewed as low risk—and 7% were exempt.
Additionally, 12% of the recalled devices that had been approved through the 510(k) process were marketed for risky indications that require full premarket review by law, according to the study.
“Our findings reveal critical flaws in the current FDA device review system and its implementation that will require either congressional action or major changes in regulatory policy,” the authors wrote in the study.
The study's release comes on the same day the FDA issued a final rule easing the approval process for some hardware and software products that are used with medical devices.
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