Most of the medical devices recalled in the FDA's highest-risk recall category were cleared for sale through the weaker of the agency's two regulatory schemes, according to a study published in the
The authors looked at the 113 medical device recalls between 2005 and 2009 that the FDA classified as posing the highest risk of serious health problems or death and determined what regulatory processes the devices had gone through.
Only 19 percent of the devices had been approved through the more stringent premarket approval (PMA) process, which requires clinical testing. Seventy-one percent went through the 510(k) process, which requires that the device be substantially equivalent to a "predicate" device already on the market. Another 11 percent did not go through either process (they were exempt, counterfeit, or categorized as "other").
The researchers wrote that the 510(k) process "was specifically intended for devices with less need for scientific scrutiny, such as surgical gloves and hearing aids." But devices became more complex. At the same time, they explained, "in an era of aggressive deregulation," the process changed to allow devices with different materials and mechanisms to serve as predicate devices if they had similar safety profiles-and to allow 510(k)-cleared devices to serve as predicate devices.
"While even the more rigorous PMA criteria for device approval are often scientifically inadequate to ensure patient safety, PMA standards are clearly superior to 510(k) standards," the authors wrote.
The authors' recommendations included putting life-saving and life-sustaining devices through PMA and expanding the FDA's authority to inspect the manufacturing of 510(k) devices and to require postmarket surveillance.
Hunter Shkolnik, a lawyer in New York City, expressed concern that if the FDA strengthens its 510(k) requirements, manufacturers will argue that state law tort claims for injuries caused by 510(k) devices are preempted, an argument they have successfully made about devices approved through the PMA process.
PMA supplements are another problem, Shkolnik said. The manufacturer of a PMA-approved device can submit a supplement to modify the device-so it can sell an altered device and still benefit from the liability protection PMA approval affords, he said.
With both 510(k) and PMA, "the FDA has to critically analyze these things, and they're not," Shkolnik said.
Paul Pennock, another New York City attorney who handles pharmaceutical device cases, said the study may be helpful in litigation. "It will help to establish that 510(k) is not an FDA approval process-it's a free pass, and it regularly results in bad devices reaching patients," he said.
Pennock added, "I am willing to bet that almost all Americans who have a medical device implanted in them or used on them believe that they have been carefully approved by the FDA."