Federal Register #2026-20726

FDA Class II classification for over-the-counter infant pulse and oxygen saturation monitors

The FDA issued a regulatory classification for over-the-counter infant pulse and oxygen saturation monitors; this notice is not a procurement or contract award. - Government agency: U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA). - OEM/requester named: Owlet Baby Care, Inc., associated with its Dream Sock device. - Device: an over-the-counter infant monitor that uses photoplethysmography to measure pulse rate and oxygen saturation and may provide caregiver alarms. - Class II special controls include clinical and non-clinical performance testing; software verification, validation, and hazard analysis; biocompatibility; electrical safety and electromagnetic compatibility testing; human factors and usability testing; and specific labeling requirements. - No products or services are being solicited for purchase, and no quantities, part numbers, contract value, or period of performance are stated.

Description

The FDA is classifying the infant pulse rate and oxygen saturation monitor for over-the-counter use as a class II medical device with special controls. The device uses photoplethysmography to measure pulse rate and oxygen saturation in infants and may include alarms for vital signs outside preset thresholds. The final order identifies special controls, including clinical and non-clinical performance testing, software verification and validation, biocompatibility, electrical safety and electromagnetic compatibility testing, human factors testing, and labeling requirements. The classification was applicable beginning November 8, 2023, and the order is effective October 9, 2026.

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