
Bias in measuring blood oxygen in patients with dark skin: comment on the FDA’s latest draft guidance for pulse oximeter makers
This document offers comment to the FDA regarding their draft guidance for makers of pulse oximeters.
The FDA’s standards for allowing medical devices on the market are too weak. As a result, dangerous — even deadly — or ineffective devices enter the market. Public Citizen’s doctors and medical experts work to ensure that medical devices are safe and effective.
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