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  • Posts tagged "medical devices" (Page 5)

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FDA Skirts Own Rules Requiring Sex-related Data For Device Approvals

March 2, 2011 / SGWHC Editorial Team / Blog
0
Cardiac Devices Should Fit Women

The Food and Drug Administration (FDA) repeatedly failed to hold cardiac device manufacturers to government standards for demonstrating safety and efficacy in women as well as men, according to a study published in Circulation and Cardiovascular QualityOutcomes.     In effect, the FDA has approved implantable and other cardiovascular devices with out  requiring the requisite data […]

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CVD, Devices, FDA, medical devices
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