Expert: Studies linking recalled 510(k) devices to problematic predicate products are ‘warning shot’ for manufacturers

Regulatory NewsRegulatory News | 17 January 2023 |  By 

Two recent studies that link the recall of 510(k)-cleared medical devices to problematic predicate products should serve as a “shot across the bow” for companies as they develop new devices headed for the less stringent US Food and Drug Administration (FDA) review pathway, an industry expert says.
The studies – Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance, and Use of Recalled Devices in New Device Authorizations Under the US Food and Drug Administration’s 510(k) Pathway and Risk of Subsequent Recalls – were published in the JAMA on 10 January.
The two papers question the adequacy of the popular device review pathway. Most devices – more than 3,000 a year – enter the US market as 510(k)s, which means they were shown to be substantially equivalent to already-authorized and marketed products.
The authors of the “Association” study reported that roughly 11% of 35,176 devices granted 510(k) clearance between 2003 and 2018 underwent a high-risk class I or moderate-risk class II recall. Of those 4,007 recalled products, 6.1% cited predicate devices that were also subject to at least one recall.
“Even though the 510(k) pathway facilitates expedient iterative device development, hundreds of 510(k) devices are recalled annually due to potential patient harm,” the authors wrote, noting that the recalls “have raised concerns that substantial equivalence may be a poor marker of safety and efficacy.”
Eric Henry, senior quality & regulatory compliance advisor at the law firm King & Spalding, said in a 13 January interview with Focus that the studies are a “warning shot across the bow of manufacturers that when you include a device as a predicate for your own submission, you should look at that device and any devices upstream that are still on the market, and incorporate those devices as part of your postmarket surveillance and postmarket risk management program.”
Despite this caution to device makers, Henry said he wasn’t alarmed by the study results.
“A lot of products, as they undergo change over time, may have a change that drives a recall. Those recalls are addressed. They are mitigated in some way, possibly resolved, and the product is made safe and effective again,” he said. “If you base a 510(k) submission on any product, the product was deemed safe and effective at the time that you declared it a predicate, based on the fact that it’s in the market in a cleared state.”
Henry further said it’s important to keep in mind that the definition of “recall” is broad and doesn’t necessarily mean a product was so troublesome or unsafe that it had to be yanked from the market.
“Companies correct their products all the time to address issues, and corrections meet the definition of a recall,” he said. “So, we need to really confine our concern to class I recalls.”
And that’s where the second study – the “Use” study – comes into play. That study’s authors reviewed 156 510(k)s that underwent a class I recall between 2017 and 2021. Of those recalled devices, roughly 44% used as predicates products that also underwent a class I recall.
“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 study authors wrote. They concluded that the review pathway needs “safeguards” so questionable predicates aren’t used in 510(k) submissions, and to “ensure patient safety.”
But the study doesn’t consider that a class I recall “can be the result of a product that was deemed safe and effective, but there are some unforeseen circumstances that occurred that drove the recall. It could also be a result of a change that occurred, and that change had an unintended impact that then drove the recall,” Henry said. “It’s impossible to really know what the impact is on the state of a submission when a predicate product may, at some future time, undergo a class I recall.”
The JAMA studies are the latest in a string of concerns about the 510(k) pathway dating back more than a decade. Several high-profile cases of patient injury have been linked to 510(k)-cleared devices, including pelvic mesh and metal-on-metal hip implants. The “Association” study also notes that the Institute of Medicine said in 2011 that “substantial equivalence to predicate medical devices is insufficient for demonstrating safety and efficacy.” In response, FDA in 2018 announced plans to strengthen and modernize the review pathway, but any major retooling of the 510(k) program would have to come from Congress, which created it.
“The 510(k) program has a lot of detractors. There are some concerns that should be addressed at some point in a review of the program,” Henry said. “And while these studies provide a piece of information, they shouldn’t be seen as an indictment of the program overall. That’s because they miss some key elements that would help us understand the relationship between a predicate product, its potential subsequent recalls, and the use of that predicate product within a 510(k) submission for a later product. We don’t really understand that impact as well as the studies might imply.”


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