FDA draft guidance addresses pulse oximeter accuracy, AI devices

Editor's Note

The US Food and Drug Administration (FDA) has issued new draft guidance January 6 providing recommendations improving the use of pulse oximeters and supporting the safety of AI-enabled medical devices, among other topics.

Released January 6, draft guidance supporting the safety and effectiveness of AI-enabled devices would, if finalized, “be the first guidance to provide comprehensive recommendations” for these throughout the total product lifecycle, including design, development, maintenance and marketing. The new guidance consolidates learnings from over 1,000 already authorized AI-enabled devices and complements recently finalized recommendations on predetermined change control plans, which address updates after market entry. Among other challenges, it addresses considerations for risk management, performance monitoring, documentation, minimizing algorithmic bias. The agency invites public comments on the guidance through April 7.

Also released January 6, FDA’s draft guidance on pulse oximeters aims to improve accuracy and performance when used with darker skin tones. The draft guidance provides manufacturers with updated recommendations for clinical data collection and study design to validate device performance for diverse populations. Specific recommendations include collecting data to assess accuracy across different skin tones; expanding study participant pools to better represent the target population; employing both subjective (Monk Skin Tone Scale) and objective (typology angle calculation) methods to assess skin tone; and updating labeling statements to verify for users that the devices have been tested and will perform as intended.

Other recent FDA press announcements cover new guidelines on including tissue biopsies in clinical trials and advancing the credibility of AI models used for drug and biological product submissions.