The Food and Drug Administration (FDA) published new draft guidelines aimed at improving the accuracy and performance of pulse oximeters by considering the range of skin tones.

The guidance, Pulse Oximeters for Medical Purposes - Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations, refers to pulse oximeters intended for medical purposes that are mostly used in hospital settings or doctors' offices.

According to the FDA, there can be accuracy differences in pulse oximeter performance between individuals with lighter and darker skin pigmentation. 

The guidance provides pulse oximeter manufacturers recommendations on ways to collect clinical data to help enhance the clinical study design and validation efforts for pulse oximeter devices used for medical purposes and to evaluate their performance across the range of skin pigmentation.

The recommendations are aimed at generating a more representative study of the intended end-user population for these devices. 

 Key elements of the FDA's draft recommendations include:

• Gathering clinical data to assess device performance accuracy across the range of skin pigmentations.

• Expanding the number of clinical study participants.

• Utilizing subjective (Monk Skin Tone Scale) and objective (calculation of individual typology angle) methods for more standardized assessment of study participants' skin tone and accurate appraisal of device performance across skin pigmentations.

• If performance accuracy has been exhibited in a new premarket submission, including a notable labeling statement to help users identify that the pulse oximeter has demonstrated that it performs equally across groups of individuals with diverse skin pigmentation and is designed for medical purposes.

"This draft guidance is aligned with the FDA's broader commitment to helping facilitate the development of high-quality, safe and effective medical devices," Dr.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

"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."

The draft guidance is not applicable to pulse oximeters sold as general wellness products or sporting/aviation products, as those products are not reviewed or evaluated by the FDA prior to being available to the public.

The FDA is requesting comments on the draft guidance within 60 days of publication. The Agency will then review and consider comments before finalizing the guidance.