MASSDEVICE ON CALL — A commentary co-authored by the California and Australian researchers called for the FDA to close the 510(k) "loophole" that allows medical devices considered a potentially "high risk" to patients to enter the U.S. market without undergoing clinical trials.
"This could be potentially very dangerous. Many Americans – patients and even physicians – are not aware of how many devices in this country are on the market without having clinical data of safety and effectiveness," co-author and University of California, San Francisco, director of women’s cardiovascular services Dr. Rita Redberg said in a prepared statement.
The perspective piece focused on metal-on-metal hip implants, which have also been the subject of high-profile recalls and thousands of patient lawsuits. Many metal-on-metal hips were cleared by the FDA by demonstrated that they’re "substantially equivalent" to other devices already on the market, rather than by demonstrating safety and efficiency on their own.
"High-risk medical devices should go through randomized clinical trials done in people so we can assure patients they are safe and effective," Redberg said. "Even the more stringent pre-market approval process doesn’t always mean that you actually have gone through randomized clinical trials, so we have to make sure these devices not only go through pre-market approval but randomized clinical trials as well."
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