Medical Devices Lack Safety Evidence, according to Recent JAMA Study
The Wall Street Journal reports that a recent study reveals that the majority of FDA approved moderate- to high-risk medical devices lack publicly available scientific evidence regarding safety and efficacy.
According to a recent study published in JAMA Internal Medicine, researchers found that 42 out of 50 specific FDA approved medical devices lacked such data, despite a 1990 regulation calling for sufficient detail in order to justify FDA clearance. Dr. Diana Zuckerman, a study author and president of the National Center for Health Research, said, “If wonderful studies are being done, there is no evidence of this, and there’s no way for the public to see it. It’s shocking how little information is available despite an FDA leadership that talks about transparency.”
The 510(K) review is a type of medical device approval whereby approximately 400 medical devices are approved each year and cleared for marketing. Under this system, the device company is not required to conduct studies in human patients – although it may. Most devices are able to receive FDA clearance simply by showing that they are roughly equivalent to another product already on the market. The theory is essentially that if the older, similar device is proven to be safe and effective, then the newer one should be too. However, this 510(K) process has led to large-scale cases for thousands of injured individuals across the country, including a recent Multidistrict Litigation involving metal-on-metal hips manufactured by DePuy (In re: DePuy Orthopaedics Inc. ASR Hip Implant Products Liability Litigation, MDL 2197).
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