MedTech Dive November 17, 2023
The agency published a paper on improving the evaluation of pulse oximeters to take skin pigmentation into account.
Dive Brief:
- The Food and Drug Administration is seeking feedback on the use of pulse oximeters in people with darker skin pigmentation ahead of an advisory committee meeting next year.
- The agency, under pressure to mitigate the risk of bias, published a discussion paper on improving the performance evaluation of pulse oximeters, taking skin pigmentation, race and ethnicity into account.
- Feedback on the paper will inform the virtual public meeting of an advisory committee that the FDA has scheduled for February. The committee will discuss how to improve premarket studies and the type and amount of data that developers of pulse...
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