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Disproportionate Number of Medical Device Recalls Due to Lax Review

by Greg Marcum, JD, PE on February 18th, 2011

A study published in the Archives of Internal Medicine on February 14 by researchers at the National Research Center for Women & Families is critical of the FDA’s medical device premarket notification and review program that is known as the 510(k) process. The study reviewed records of medical devices that were recalled from 2005 to 2009 due to defects which could potentially cause life-threatening or serious harm.

The FDA 510(k) process allows the agency to review 3,000 devices per year via a fast-track process that does away with clinical trials otherwise required of new medical devices. Only devices which are considered low- to moderate-risk devices and which are “substantially similar” to existing devices already on the market are eligible for 510(k) review. The study found that 80 out of 113 (71%) of recalled products were cleared through the shorter 510(k) review. In response, an industry group and the FDA alleged the study contained factual errors and faulty data analysis. Their primary argument is one of scale. With 3,000 devices cleared per year over the 2005 – 2009 time-frame,  only 113 out of 15,000 devices were recalled, a rate of less than one-tenth of one percent. Their secondary argument is one of patient access – the 510(k) process allows certain medical devices to be made available to U.S. consumers much sooner than the clinical trial process. Other countries have similar programs that result in foreign patients having access to some devices 2-33 years before U.S. patients.

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From → Health Law