Evidence Lacking to Support Most Devices Cleared by FDA’s 510(k) Process

October 8, 2014 | Strategic Insights for Health System


​For most of the implanted medical devices cleared between 2008 and 2012 by the U.S. Food and Drug Administration's (FDA) 510(k) process, manufacturers did not make scientific evidence of substantial equivalence publicly available, according to the results of a study published September 29, 2014, in JAMA Internal Medicine. The study's researchers used FDA's databases to determine the device categories of the first five implanted medical devices cleared through the 510(k) process in 2008 (cardiovascular, dental, general and plastic surgery, neurological, and orthopedic), then identified the first two implanted medical devices approved in each of these categories for each year from 2008 through 2012. They found that scientific data to support the claim of substantial equivalence was publicly available for 8 of the 50 devices sampled (16%) and 31 of their 1,105 listed predicates (3%).

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