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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

UPDATE: Pulse Oximeter Accuracy and Limitations - FDA Safety Communication

The FDA continues to evaluate all available information pertaining to factors that may affect pulse oximeter accuracy and performance. Because of ongoing concerns that these products may be less accurate in individuals with darker skin pigmentations, the FDA is planning to convene a public meeting of the Medical Devices Advisory Committee later this year to discuss the available evidence about the accuracy of pulse oximeters, recommendations for patients and health care providers, the amount and type of data that should be provided by manufacturers to assess pulse oximeter accuracy, and to guide other regulatory actions as needed. Further details concerning the agenda, timing and location of the Advisory Committee meeting will be announced in the coming weeks.

Questions?

If you have questions about this safety communication, contact the Division of Industry and Consumer Education (DICE).