On Nov. 16, the FDA announced two new initiatives to help ensure pulse oximetry is equitable and accurate for all patients.
To that end, the FDA published a new discussion paper for public comment outlining one possible approach to improve the quality of premarket studies and associated methods used to evaluate the performance of pulse oximeters, taking into consideration patient skin pigmentation and patient-reported race and ethnicity.
The agency also announced an upcoming advisory committee on Feb. 2, 2024, where pulse oximeters will be discussed.
FDA has the annoucement.
