FDA Panel Prefers Enhanced Labeling for Pulse Oximeters, Larger Clinical Trial Group

Pulse oximeter manufacturers should conduct larger premarket studies to evaluate the accuracy of the devices when used on individuals with differing skin pigmentation, according to an FDA advisory committee.

The Anesthesiology and Respiratory Therapy Devices Panel met Friday to discuss how to improve premarket studies and methods that evaluate pulse oximeters, considering specifically a patient’s race, ethnicity and skin pigmentation. Clinical trials should be more inclusive and representative of different patient profiles, the committee said, advising larger trial groups than the 24 healthy participants currently recommended by the FDA.

The panel also addressed the labeling of OTC pulse oximeters and differences with the devices used by practitioners, suggesting both OTC and medical-grade oximeters should be similar in data standards with simplified but concise labeling.

Read the FDA Executive Summary here.

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