The Safe Medical Devices Act, 1990 requires

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The Safe Medical Devices Act, 1990 requires that injuries, illness, or death from any device be reported. The act also requires manufacturers and importers of medical devices to report  to the Food and Drug Administration (FDA) any device-related deaths, serious injuries, or illnesses. This helps to ensure that the FDA is informed of any potential safety issues with medical devices and can take appropriate action to protect the public.

The Safe Medical Devices Act, 1990 Requires