The FDA’s 510(k) provides companies with a faster and more cost-effective clearance pathway for medical devices. As a result, many new medical devices enter the market via this process. Last year, GlobaData’s database accounted 90% of medical devices entering the US market to be approved through a 510(k) process. Approval of the device will require to show substantial equivalence to a predicate device on the market.

Though, the 510(k) program has allowed to expedite the time it takes for these potential lifesaving devices to reach the hands of patients, critics have highlighted a loophole in the system. According to Eric Henry, senior quality & regulatory compliance advisor at the law firm King & Spalding, overtime predicate devices that are used as blueprints for new devices may have changed in such a way that “drive[s] a recall”. The main concern revolves around predicate devices that underwent class 1 recalls. Current regulations continue to allow manufacturers to use devices that were subject to a Class I recall as predicates to new devices if the recall was voluntarily performed by them.

Two 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 conducted to further understand the relationship between predicate devices and new devices under a 510(k). One of the studies tracked down 127 predicate devices out of a pool of 156 devices subjected to a 510(k) between 2017 and 2021. The findings were that 44% were approved based on predicates that had undergone their own Class 1 recalls. Though it’s important to note, that the study does not account for unforeseen circumstances that could have led to the recall, after being deemed safe and effective.

Attempts to close the loophole were made back in 2012 in response to injures from patients from metal-on metal hip implants, but the proposal failed to reach Congress.

Companies fast tracking their product development through the 510(k) process may incorporate these device testing tips provided by Qualio to ensure safety, efficacy, and substantial equivalence prior to submission:

1. Set the testing criteria based on the product claims of the predicate device

2. Reference ISO 14971

3. Research historic recalls associated with your device, focusing on reoccurring faults

4. Track design control activity of device

What are other suggested strategies that will help increase the transparency in the use of predicate devices and safeguard new medical devices for patient safety? What can reduce the probability of a device recall if using a predicate device to undergo a 510(k)?

Overview Discussion: https://www.raps.org/news-and-articles/news-articles/2023/1/expert-studies-linking-recalled-510k-devices-to-pr

Litigation Insight: https://www.bowmanandbrooke.com/insights/recalls-and-predicates

510k Process: https://www.drugwatch.com/fda/510k-clearance/