An FDA pathway to clear medical devices is putting patients at risk, research suggests

The Food and Drug Administration’s approach to evaluating some new medical devices might actually increase the risk that those devices will later be recalled over safety concerns.

For some medical devices, the FDA requires data from studies in people to show that the device, including things like implantable heart defibrillators or stents, is safe and effective. That process is roughly equivalent to how regulators review new medicines. But the FDA also approves devices including artificial joints, infusion pumps, and scalpels using a process known as the 510(k) pathway, which simply lets manufacturers show that the new devices are “substantially equivalent” to products already on the market. 

Two new papers published Tuesday in JAMA look at a specific wrinkle of the 510(k) problem: What happens if a new medical device is approved based on a device that has been recalled because of a safety problem?

The first paper, by a team that included Kushal Kadakia of Harvard Medical School and Harlan Krumholz of Yale University, looked at cases in which a device underwent what the FDA calls a Class I recall – meaning the device was temporarily removed from the market because of, in the FDA’s words, “a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.” Specifically, the researchers looked at cases in which a newer device was cleared using a comparison to the recalled device.

They found that devices that were approved based on comparison to a device that had previously undergone a Class I recall were about six times more likely to themselves be recalled than similar devices.

“This regulatory loophole allows safety issues to propagate for years and years, placing patient safety at risk,” Kadakia said.

In a statement, the FDA pushed back against the findings. “The Center for Devices and Radiological Health takes steps to prevent or discontinue the marketing of a device that relies on a recalled predicate where the root cause of the recall has not been adequately addressed in the new device, including, where appropriate, denial of clearance,” the agency said in a statement.  

“In addition, the agency has taken numerous steps to strengthen the 510(k) program performance, predictability, efficiency and safety. For example, we’ve clarified premarket expectations through guidance, implemented a refuse to accept policy to improve the quality of submissions, and improved consistency and thoroughness of review through implementation of standardized electronic review templates.”

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