The FDA released a draft guidance titled "Pulse Oximeters for Medical Purposes: Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations". The guidance seeks to provide updated recommendations for the performance testing, labeling, and premarket submissions of pulse oximeters—devices widely used by healthcare professionals and consumers to monitor blood oxygen saturation noninvasively.

"This draft guidance is aligned with the FDA's broader commitment to helping facilitate the development of high-quality, safe, and effective medical devices," said Michelle Tarver, M.D., Ph.D., director of the FDA's Center for Devices and Radiological Health.

Once finalized, the document will replace the 2013 guidance, reflecting advancements in device technology and updated expectations for performance standards. The draft emphasizes the need for manufacturers to conduct robust performance testing under diverse conditions and populations to ensure accurate readings, particularly for individuals with varying skin tones. This stems from concerns about potential inaccuracies in pulse oximeter readings in patients with darker skin pigmentation, an issue highlighted in recent studies and clinical observations.

"Our draft recommendations are based on the best available science to help address concerns of disparate performance of pulse oximeters based on an individual's skin pigmentation," Dr. Tarver added.

The guidance outlines specific non-clinical and clinical testing requirements. For non-clinical evaluation, the FDA recommends assessing device accuracy, robustness, and potential interference from factors such as motion artifacts, ambient light, and low perfusion. Clinical performance testing is advised to evaluate the device's accuracy under controlled oxygen desaturation studies involving subjects with a broad range of skin tones.

Additionally, the FDA provides detailed labeling recommendations, requiring manufacturers to disclose known limitations, including potential variations in accuracy due to pigmentation. The guidance also suggests including disclaimers about the conditions under which pulse oximeters may be less reliable, such as low perfusion states or high-motion environments.

Manufacturers are encouraged to submit public comments on the draft guidance until March 7, 2025. The FDA stated that the finalized guidance will aim to address current challenges associated with pulse oximeter accuracy while fostering innovation and ensuring patient safety.

Pulse oximeters have seen widespread use in both medical settings and at home, particularly during the COVID-19 pandemic, for monitoring respiratory conditions. This guidance underscores the agency's effort to align performance standards with evolving clinical needs and public health priorities.

For further information or to access the full draft guidance, visit the FDA's website or review the document through the Federal Register.

Reference:

U.S. Food and Drug Administration. Pulse oximeters for medical purposes: non-clinical and clinical performance testing, labeling, and premarket submission recommendations