But not everyone is convinced by these findings. The National Research Council for Women & Families, a Washington, DC-based advocacy group long critical of the 510(k) process, dismissed the industry’s interpretations.

“The issue is not what percentage of 510(k) devices are recalled,” Dr. Diana Zuckerman, the group’s founder, told DOTmed News. “The issue is how many people are harmed. So, you can have one recall that affects 20 million people.”


As an example, she mentions the 2000 recall of more than one million bottles of contact lens solution. Some of the bottles, contaminated by a fungus, led to eye injuries and even in some cases, blindness.

Further, she said the reports aren’t accurate because no one knows what the “real” denominator is for the 510(k) process. Many cleared devices are never sold, she argues, either because the company decided to discard the product or because it only got approval for the device to use it as a “bridge” product. That is, to use it as a predicate device for which to clear another product.

“There should be zero high-risk recalls,” she said. “If a product by 510(k) is, by law, not a high-risk product, it should not end up with a high-risk recall. If it’s a high-risk recall, the product was high-risk to begin with.”

Public Citizen, a corporate watchdog group founded by Ralph Nader, also finds the process lacking. In the July 2010 article “Left to Their Own Devices: Breakdowns in United States Medical Device Premarket Review,” published online in the peer-reviewed journal PloS Medicine and co-authored by Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, the organization noted that device approvals were generally laxer than drug ones.

“In practice, [New Drug Applications] typically contain two or more well-controlled clinical studies, whereas for PMA applications, a single study is the norm and most 510(k)s contain no clinical data,” the authors wrote. “Thus, data that would never be sufficient to support the approval of a drug can result in the approval of a device used to treat the same condition, potentially diverting patients from effective drugs to less-effective devices.”

As an example, the authors cite the approval of a vagus nerve stimulator, intended to treat depression, using evidence that an FDA psychopharmacology expert said would not suffice for an antidepressant drug.

Even so, PMAs get almost five times more attention than 510(k)s, according to the paper. The average review time – circa 2006 – for a 510(k) submission is only 54 days, whereas it’s nearly 283 days for PMAs.

“The 510(k) premarket approval process has failed to keep dangerous and ineffective medical devices from the market,” Public Citizen concludes on its website.

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