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US reclassifies certain software, hardware used with devices as low-risk

This article was originally published in RAJ Devices

Executive Summary

The US Food and Drug Administration has issued a final rule that reclassifies certain software and hardware products used with medical devices as Class I or low-risk products1,2. Until now, these devices were considered to be either Class III (high-risk) devices requiring pre-market approval or accessories to an existing medical device.

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