MedTech Dive November 7, 2023
The AGs want the FDA to “require manufacturers and vendors of pulse oximeters to include clear, comprehensible and evidence-based warning labels.”
Dive Brief:
- Attorneys general from 25 states have asked the Food and Drug Administration to “act with urgency” to address pulse oximeters’ race and color bias, one year after the agency held a public meeting in response to accuracy and safety concerns.
- In a letter to FDA Commissioner Robert Califf, the attorneys general outline evidence that the accuracy of pulse oximeters is affected by skin tone and call on the regulator to immediately take six actions to ensure the safety and effectiveness of the devices.
- The attorneys general want the FDA to “require manufacturers and vendors of pulse...
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