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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
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Medical Device Industry Responds

The study, which is published in the Archives of Internal Medicine, comes as the FDA is weighing changes to how it approves medical devices. It drew sharp criticism from the medical device industry, which countered that the percentages of class I (highest-risk) recalls involving products given 510(k) reviews is small compared to the absolute number of products approved under that program each year.

“There are more than 3,000 devices and diagnostics cleared through the 510(k) process every year compared to 20-40 products cleared through the PMA [premarket approval] process. To conclude that the safety profile of the 510(k) process is inferior because a larger number of 510(k) products are recalled is like concluding that the United States’ system of cancer care is inferior to Monaco’s because more people die of cancer in the U.S. each year than in Monaco without considering the population differences,” says AdvaMed, a group that lobbies for the medical device industry, in a statement.

The researchers, however, stand by their analysis, saying that they were focused on patient safety.

“Our decision to focus on the numberof high-risk recalls that were cleared through the less stringent 510(k) process, rather than the percentageof 510(k) clearances that were later recalled, is not an error in data analysis,” Zuckerman says. “It represents the public health approach to the problem, rather than the industry approach.” 

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.

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