Reforms Needed in FDA’s 510(k) Process, Studies Say

Applications to the FDA for new devices that cited predicate devices subject to ongoing recalls resulted a higher risk of recall of the new devices, two research teams reported in the Journal of the American Medical Association (JAMA).

The first study, led by Harvard health economist Alexander O. Everhart, evaluated 35,176 devices cleared through the 510(k) pathway between 2003 and 2018 and subsequent recalls. The analysis found that 11 percent of new devices experienced a Class I or II recall, noting that sponsors submitting applications for new devices that cited similar predicate devices that had ongoing recalls resulted in a 14 percent higher relative risk of recall. 

A second study, led by Kushal Kadakia of Harvard, found that among the 156 devices authorized through the 510(k) pathway with Class I recalls from 2017 through 2021, nearly half had used predicates that had been subject to Class I recalls themselves, including a large number that were both known and unresolved at the time. 

The findings raise the question: “Why would a device with an ongoing recall be allowed to serve as a predicate for any new device authorization?” wrote Daniel B. Kramer and Robert W. Yeh, both of Harvard Medical School, in a JAMA editorial focused on the two studies.

Kramer and Yeh noted that when devices cited predicates that had been subject to Class I recalls they had a more than six-fold risk of themselves being subject to a future recall. They called this “a critical weakness in the current 510(k) process.”