FDA Releases Draft Guidance on Pulse Oximeters for Medical Purposes – Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations

FDA Issues Draft Guidance to Improve Accuracy and Address Bias in Pulse Oximeters

The FDA has released a draft guidance document aimed at improving the accuracy of pulse oximeters and addressing concerns about potential racial bias in their readings. This comes in response to growing evidence that pulse oximeters may be less accurate for people with darker skin pigmentation, potentially leading to health disparities.

• Addressing bias: The guidance emphasizes the need to evaluate pulse oximeter performance across different skin pigmentation levels to ensure accurate readings for all patients.
• Non-clinical and clinical testing: Within the document are recommendations for both non-clinical and clinical performance testing, including specific studies to assess accuracy in individuals with varying skin pigmentation.
• Labeling updates: The FDA is recommending updates to pulse oximeter labeling to inform users about potential limitations and factors that may affect accuracy, including skin pigmentation.
• Focus on safety and effectiveness: The overall goal is to promote the safe and effective use of pulse oximeters by providing clear and comprehensive information to both healthcare providers and patients.

Pulse oximeters are widely used in healthcare settings and at home to monitor blood oxygen levels. Inaccurate readings can lead to delayed or inappropriate treatment, particularly for individuals with darker skin tones. This guidance represents a significant step towards ensuring equitable and reliable healthcare for all patients. By addressing potential bias and improving accuracy, the FDA is working to enhance the safety and effectiveness of these important medical devices.

For the original update, please visit the FDA’s website.

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Questions?

For any further questions on the requirements on marketing your Pulse Oximeter as well as assistance with your submission to the FDA, please email mdi Consultants at: [email protected] RE: PulseOX.