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Benefits Of Non-Regulated Medical Software Far Outweigh Their Risks: Report

The US FDA’s latest report on non-regulated health and medical software finds they are not associated with any substantial increase in risks, though the agency admits there may be some underreporting.

Balancing stones on a blue sky and sea background.

The US Food and Drug Administration says based on data it has gathered and reviewed, certain medical software that are not regulated by the agency don’t carry a significant level of risk.

Under the 21st Century CURES Act, the FDA is required to collected data on five types of medical software that are not regulated by the agency, and therefore are not...

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