A coalition of patient, consumer, and public health groups urged the federal Food and Drug Administration to require more rigorous testing before a medical device used for addressing complications from aneurysm treatments can be sold.
“This decision by FDA sets a bad precedent for approving new devices,” said Lisa McGiffert, Director of Consumers Union’s Safe Patient Project. “Medical devices intended to save lives should require the FDA’s most rigorous safety testing. Bypassing such testing up front can put hundreds of thousands ...
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