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# Reducing the Potential for Pulse Oximeter Bias
- URL: https://www.fdaweb.com/reducing-the-potential-for-pulse-oximeter-bias/
- Published: 2024-01-17T12:00:00.000Z
- Updated: 2026-09-14T14:20:32.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156150

Medtronic says it supports FDA efforts to further enhance industry standards for pulse oximeters and to reduce potential health disparities related to using the devices by considering skin pigmentation, race, and ethnicity. Commenting on an agency discussion paper on the topic, Medtronic [says](https://www.regulations.gov/comment/FDA-2023-N-4976-0006?ref=fdaweb.com) that while there is still work to do to finalize guidelines and standards for using pulse oximeters, “we have made significant progress over the past 18 months, which is reflected in FDA’s discussion paper. We believe that by being united in purpose (across FDA, industry, patient groups, and other stakeholders), our collective efforts will culminate in transformative change in this area, ensuring equitable care for all patients regardless of skin color.”

In its [response](https://www.regulations.gov/comment/FDA-2023-N-4976-0005?ref=fdaweb.com), AdvaMed says FDA should set requirements that are supported by scientific evidence. “There is not yet enough data to support the agency’s recommendations around non-disparate bias requirements,” it says. It also notes such a requirement is not in the draft International Standards Organization standard with which AdvaMed says FDA should align its standard and any future guidance.