Recall Study Results Suggest 510(k) Reform Needed

A new study examining high-risk recall rates of medical devices in the US has added weight to contentions that the Food and Drug Administration’s 510(k) clearance process needs strengthening. Industry advocates including the Advanced Medical Technology Association (AdvaMed) have wasted no time decrying the study’s methodology and results. But that should prove hardly surprising given how doggedly AdvaMed has pushed against any moves to make the 510(k) process more rigorous. The study, available on the Archive of Internal Medicine’s website, assessed 113 serious medical device recalls made between 2005 and 2009 using data available on the FDA website; researchers found that only 21 of those recalled products had gone through the FDA’s stringent premarket approval (PMA) process, while 80 of those products had obtained less strict 510(k) clearances and eight additional products had been exempted from FDA review. Of the largest category of recalled devices—cardiovascular products—two-thirds of those devices had earned 510(k) clearances. Acknowledging (and anticipating) arguments made by (AdvaMed) that the number of 510(k)-cleared devices recalled between 2005 and 2009 constitute a small percentage of products cleared through premarket notification, study authors Diana Zuckerman, Paul Brown and Steven Nissen posit that such statistics do not take into account the impact of such recalls on public health. If the FDA continues to rely on the 510(k) process to clear devices for the US market, they argue, then that process must more vigorously assess those devices before commercialization. The study also recommends four changes to the FDA review process to reduce future recalls. First, the FDA should fully implement current law requiring submission of all Class III devices to the PMA process. Second, FDA definitions of high-risk devices should include potential risks of those devices’ failures. Third, the FDA should inspect 510(k) device manufacturing as the agency currently does for PMA devices. Finally, the agency should apply the same special controls in place for PMA devices—postmarket surveillance, performance standards and general-guidance documents—to 510(k) devices.

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