- Medical devices that cite predicate products that are subject to recalls in their 510(k) filings are more likely to be recalled, according to studies published in the Journal of the American Medical Association.
- A pair of studies tackled the topic from different angles. One study found devices that reference predicate products with three or more ongoing recalls are significantly more likely to be recalled themselves. The other study showed predicates subject to Class I recalls increased the risk of the new device being subject to the same regulatory action by 6.4 times.
- The authors of the second study see their research as evidence that “stronger safeguards are needed to prevent problematic predicate selection and ensure patient safety.”
Currently, 510(k) filings can cite previously approved devices, known as predicate devices, that are subject to actions by the U.S. Food and Drug Administration, including Class I recalls. The two papers seek to show how the characteristics of predicate devices affect the likelihood that the newly cleared products will face regulatory problems.
The larger of the two studies took a broad look at the question by analyzing the 35,176 medical devices cleared by the FDA between 2003 and 2018 via the 510(k) pathway. The researchers evaluated the links between a range of characteristics of the predicate devices, including recall status and age, and the likelihood of a new product being recalled.
Applicants that cited predicate devices with three or more ongoing recalls were 81.2% more likely to be recalled compared to the average. The researchers found applicants that cited older medical devices were less likely to be subject to recalls of their newly cleared products.
The second study had a narrower focus, looking specifically at the 156 devices that received 510(k) clearance and were subject to Class I recalls from Jan. 2017 through Dec. 2021. In that dataset, 56 devices used predicates that had been part of a Class I recall.
In light of the “substantially higher risk of a subsequent Class I recall,” the researchers said “safeguards for the 510(k) pathway are needed to prevent problematic predicate selection and ensure patient safety.” The authors of the larger, broader study reached a different conclusion, stating that “regulators would need to weigh multiple factors ... when deciding whether to change the requirements about which predicate medical devices can be cited in 510(k) submissions.”