Developers of pulse oximeters will need to demonstrate that their devices are effective across a wide range of skin tones under new guidance from the US Food and Drug Administration.
Pulse Oximeter Guidance Calls For Greater Diversity In Trial Populations
The FDA's new draft guidance for pulse oximeters requires developers to demonstrate device effectiveness across diverse skin tones to address accuracy issues, especially for people with darker skin. The guidance includes clinical study requirements, labeling changes, and recommendations for comparing new devices to predicates.
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