A 510(k) clearance “is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device,” according to the agency, meaning new devices can align themselves with previously approved devices, some of which have been recalled because of the risk of death or serious adverse effects.
The study found that of the 156 medical devices that carried the 510(k) sticker and were part of a Class I recall from 2017 through 2021, 44.1 percent had predicates with known safety issues.
“Devices that were authorized using these predicates were 6.4 times more likely to be subject to a Class I recall than were devices that used recall-free predicates,” the researchers wrote.
A second study, also published Jan. 10 in the Journal of the American Medical Association, showed products were more likely to be recalled if they were cleared based on similar data from another recalled device.
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