Many Recalled 510(k) Devices Had Recalled Predicates: Study

Researchers from several academic medical centers say that among 156 medical devices cleared through the 510(k) pathway and subject to a Class 1 recall from 2017 through 2021, 44.1% were authorized using predicates that were also subject to Class 1 recalls. Devices authorized using these predicates were 6.4 times more likely to be subject to a Class 1 recall than were devices that used recall-free predicates, they report in the Journal of the American Medical Association.

The researchers say that safeguards for the 510(k) pathway are needed to prevent problematic predicate selection and ensure patient safety.

The study notes that the Federal Food, Drug, and Cosmetic Act “appropriately prohibits devices from serving as predicates if they are subject to mandatory recalls, but there is a loophole. Manufacturers may use, and FDA may authorize, devices that use recalled predicates if the predicate was recalled voluntarily by the manufacturer.”

The researchers say that voluntary manufacturer recalls are the usual approach for medical devices, with FDA exercising its recall power just three times between 1990 and 2010.

FDA says a “submitter is permitted to cite as a predicate a device that has been recalled by the manufacturer due to safety concerns,” the study says, and estimates that this affects less than 1% of the 3,000-some devices authorized annually under the 510(k) pathway.

However, the authors say their analysis shows the practice is common among devices subject to Class 1 recalls. Notably, the authors write, most of the Class 1 recalls were still active at the time of new device authorization, meaning that descendants were being cleared using predicates for which safety concerns were not only known but had yet to be resolved.