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A member asked:
Does fda test medical devices?
A doctor has provided 1 answer
Yes but not directly: The fda requires approval for marketing of devices that monitor, treat, or diagnose medical problems. They do not directly test the devices but have approved third party companies that can verify the function and accuracy of devices and may require clinical trial data or some types of devices (ie. Those used to diagnose, monitor or treat serious conditions).
Answered 7/29/2012
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