The Food and Drug Administration put patients' lives at risk by halting enforcement of 30-year-old requirements that medical device makers meet federal laboratory standards prior to testing their products on humans, a watchdog group charges in a new report.
The rules at issue cover studies on an array of devices, including life-saving products such as defibrillators, pacemakers, coronary stents and heart valves.
Bush FDA decision put patients in danger
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A...
