New FDA Pulse Oximetry Guidance: Strengths and Weaknesses

The US Food and Drug Administration (FDA) issued new draft regulatory guidance for pulse oximeters related to skin pigment. The guidance is a step forward but it may have unintended consequences. Authors Michael Lipnick, MD, and Philip Bicker, MD, PhD, professors of anesthesia at University of California, San Francisco, discuss this and more with JAMA Executive Editor Gregory Curfman, MD. Related Content: Pulse Oximetry and Skin Pigmentation—New Guidance From the FDA Adherence to FDA Guidance on Pulse Oximetry Testing Among Diverse Individuals, 1996-2024 Addressing Racial and Ethnic Bias in Pulse Oximeters—A Wicked Problem Evaluating the Accuracy of Pulse Oximetry in Children According to Race