6 doctors weighed in:

Does fda test medical devices?

6 doctors weighed in
Dr. Foster Carr
General Practice
5 doctors agree

In brief: 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).

In brief: 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).
Dr. Foster Carr
Dr. Foster Carr
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