Also, the concept of "substantially equivalent" has been modified over the years to allow that classification even for devices made from different materials and which use a different mechanism of action.
The FDA did not respond to a request for comment on the report.
Zuckerman, Brown and Nissen noted that the resource-challenged FDA uses the 501(k) process "because it is less expensive and enables the relatively small Center for Devices and Radiological Health (CDRH) to review thousands of devices each year."
For example, the average cost for the FDA to review a 510(k) submission "was estimated at $18,200, while a PMA submission cost the agency $870,000 to review," they wrote.
Of these recalls, the largest group were for cardiovascular use and 35 – involving 31 separate devices – and most were automated external defibrillators (AEDs) approved for resuscitation of patients in cardiac arrest. About one in five of the one million AEDs in circulation have been recalled, "and hundreds of people died due to AED malfunction," the researchers wrote. Of these 35, 23 were cleared through the 510(k) process.
The second largest high-risk recall category involved 27 general hospital devices, such as insulin pumps, intravenous infusion devices and patient lifts. Of these, 20 (74%) were cleared through the 510(k) process.
The third largest high-risk recall category involved devices used in anesthesia, including mechanical ventilators. All were cleared by the 510(k) process or were exempt.