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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Pulse Oximeter Safety Communication Updated with Advisory Committee Meeting Information

The U.S. Food and Drug Administration (FDA) is announcing a virtual meeting of the CDRH Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee on November 1, 2022, from 9 a.m. to 6 p.m. Eastern Time.

The committee will discuss ongoing concerns that pulse oximeters may be less accurate in individuals with darker skin pigmentations. The committee will also discuss factors that may affect pulse oximeter accuracy and performance, the available evidence about the accuracy of pulse oximeters, recommendations for patients and health care providers, and 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.

Questions?

For additional meeting details, see the meeting announcement in the Federal Register.

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