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Study: Recalled Devices Had Less Strict FDA Review

Researchers Say Many Recalled Medical Devices Were Approved in a Less Intensive Process

Medical Devices and the FDA

The FDA classifies medical devices into three categories, based on their potential to cause harm to patients.

Class I devices are the least risky and include things like tongue depressors, bandages, and crutches. Class II devices involve intermediate risk, and these include things like hearing aids, contact lens solutions, hip and knee implants, and powered wheelchairs. Class III devices pose the most risk to patients and include things like pacemakers, heart stents, and HIV diagnostic tests.

Class III devices are intended by law to undergo premarket approval, a process that requires extensive testing, including “valid scientific evidence” to assure that a device is safe and effective for its intended use. Most class I and some class II devices are exempt from premarket approval but are cleared for market through the 510(k) process.

In recent years, the researchers note an increasing number of class III devices that should have gone through premarket approval instead went through the 510(k) process.

When a product has been shown to have substantial safety concerns, either because it is defective, dangerous, or both, it is recalled.

The FDA has three levels of recalls, I through III. Class I is considered the highest risk recall, indicating that there’s potential for a product to cause serious harm or death.

Investigating Device Recalls

For the current study, researchers analyzed class I recalls from January 2005 through December 2009.

Of 113 Class I recalls during that time, only 21 of those products, or 19%, were found to have been approved through the more stringent premarket approval process. Eighty products were given 510(k) clearance. Eight were exempt from regulation or were merely registered with the FDA.

“Simply put, this means that more often than not, the highest-risk medical devices are being approved, marketed, and used in patients without any clinical trial data,” says Rita F. Redberg, MD, a cardiologist and professor of medicine at the University of California, San Francisco, who wrote a commentary that accompanied the study.

“Undoubtedly, we need more clinical trials of high-risk devices,” Redberg says.


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