Studies find fault in FDA approval process for implanted medical devices
October 02, 2014 12:00
Even though it's an FDA requirement, most implanted medical devices lack publicly available scientific evidence that shows that they're "substantially equivalent" to devices already on the market, according to a new study published in JAMA.
Researchers at the National Center for Health Research in Washington put together a sample of 50 devices ranging from hip implants to surgical mesh that received FDA approval from 2008 to 2011. They also looked at 1,105 devices that were already on the market.
DOTmed News
Studies find fault in FDA approval process for implanted medical devices
October 02, 2014 12:00
Even though it's an FDA requirement, most implanted medical devices lack publicly available scientific evidence that shows that they're "substantially equivalent" to devices already on the market, according to a new study published in JAMA.
Researchers at the National Center for Health Research in Washington put together a sample of 50 devices ranging from hip implants to surgical mesh that received FDA approval from 2008 to 2011. They also looked at 1,105 devices that were already on the market.
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