The scientific evidence backing up the clearance of many medical devices is often not publicly available, according to a study appearing in JAMA Internal Medicine.
Through its 510(k) process, the US Food and Drug Administration clears moderate to high-risk medical devices for use, often by device makers showing that their product is" substantially equivalent" to one already on the market, the study notes.
Researchers led by Diana Zuckerman from the public health think tank National Center for Health Research examined the evidence used to determine such equivalence for a sample of 50 implantable devices cleared between 2008 and 2012. Zuckerman and her team found that scientific data supporting the claims was publicly available for only eight of the newly cleared devices. Further, data was only available for 31 of 1105 predicate devices.
"If wonderful studies are being done, there is no evidence of this, and there's no way for the public to see it," Zuckerman tells the Wall Street Journal. "It's shocking how little information is available despite an FDA leadership that talks about transparency."
In their paper, she and her colleagues call for better enforcement of the Safe Medical Devices Act of 1990, which requires summaries of the scientific evidence submitted for 510(k) reviews to be made publicly available.
According to the Journal, FDA said that it "reviews a significant amount of data — far more than what is publicly available."