When medical devices that have been cleared under the FDA’s “fast track” 510(k) pathway are recalled, how often did the similar older versions (predicates) get recalled? That’s the question posed by three researchers whose findings on the subject were published as a cross-sectional retrospective analysis in the Jan. 10 edition of the Journal of the American Medical Association

The researchers found that while “nearly all medical devices progress to market under the 510(k) pathway,” some products approved under the 510(k) approval process were subjects of Class I recalls—the FDA’s most serious recall classification, in which a medical device is deemed dangerous enough to cause serious injury or death.

Of 156 medical devices that were approved under the 510(k) approval pathway and later subject to Class I recall from 2017 through 2021, 56 of them (44.1%) were approved based on an older device that was also subject to a Class I recall.

To receive authorization under the FDA’s fast-track approval to sell in the US market, medical device manufacturers submit a 510(k). This premarket submission is designed to demonstrate to the FDA that the medical device is safe and effective based on being “substantially similar” to a previously approved device. If a medical device manufacturer selects a predicate device and demonstrates with proper documentation that the new device is equivalent to the older, already-approved device, the FDA is more likely to approve the 510(k). 

Due to the findings of the researchers, however, the 510(k) approval process is being questioned. “Many 510(k) devices subjected to Class I recalls in the US use predicates with a known history of Class I recalls. These devices have substantially higher risk of a subsequent Class I recall,” the researchers conclude, adding, “Stronger safeguards are needed to prevent problematic predicate selection and ensure patient safety.”  

The associated risk of a medical device that was granted fast-track approval and ultimately issued a Class I recall was over 6 times higher for medical devices using a predicate never issued a Class I recall. Based on their data, the researchers note that predicate devices that have been recalled should not be the basis for future approvals.