Study: Unsafe medical devices gain FDA approval through loophole

Editor's Note

A study done by investigators from Yale, Harvard, and the University of California-San Francisco, published on January 10 in JAMA, found that “many medical devices subject to recall had received Food and Drug Administration (FDA) approval based, in part, on the products’ similarities to earlier devices,” Healthcare Purchasing News January 24 reports.

That is a loophole in federal law that some manufacturers use. Because FDA authorization for most medical devices can be based on similarities to other approved devices, “manufacturers are often allowed to bypass clinical testing by building on previous FDA approvals,” noted the article.

The study also found that many of the approved devices used as a basis for new approvals had also been recalled, including Class I recalls (an FDA designation that indicates possible patient harm or death). That means the loophole found was a way for more unsafe medical devices to enter the market based on earlier products that were also unsafe.

The study “reconstructed the regulatory history of all medical devices that were subject to Class 1 recalls from 2017 through 2021,” and found that:

• safety issues were pervasive
• 44% of recalled devices were related to older devices that had been subject to earlier Class 1 recalls
• approximately one in four of these earlier devices were recalled before the FDA approved the next generation of devices
• the new devices, in turn, often supported the authorization of additional devices that also were later recalled.

The investigators also compared the recall rates among devices that were approved based on recalled devices versus recall rates among devices approved based on recall-free products. “They found that devices approved using recalled devices were more than six times as likely to be subject to a Class I recall,” the study concluded.