Many cardiac implantable electronic device models now in use were approved via a Food and Drug Administration review process in which the models were assumed safe and effective based on approval of prior versions of the device. This is according to a study in the January 22/29 issue of emJAMA/em. "In the United States, the Food and Drug Administration (FDA) reviews high-risk medical devices-those that support human life, prevent illness, or present ...
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titled Most CV Devices Approved by Process Does Not Require New Clinical Data.
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Thursday, January 23, 2014
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