A 29-year-old member asked:

Does fda test medical devices?

1 doctor answer6 doctors weighed in
Dr. Foster Carr
General Practice 35 years experience
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).
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Last updated Jul 29, 2012


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