Is the FDA Too Easy On Medical Devices?

Sounds like the FDA is about to get tougher on new medical devices: The acting director of the agency’s device division tells the WSJ and New York Times that stricter criteria for approval are on the way. His comments come as a couple new journal articles suggest many devices are approved based on studies that lack rigor. One article, published in JAMA , looked at cardiovascular devices that were approved by the FDA between 2000 and 2007 and were subject to the agency’s most stringent level of scrutiny for devices

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Is the FDA Too Easy On Medical Devices?

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Filed under: ED • FDA • IT • Medical Devices • Uncategorized • heal • health • quality

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