U.S. FEDRegulation
FDA classifies over-the-counter infant pulse rate and oxygen saturation monitor as class II
The Food and Drug Administration classified the over-the-counter infant pulse rate and oxygen saturation monitor into class II with special controls. The agency determined the classification provides reasonable assurance of the device's safety and effectiveness and said it should expand patient access to innovative devices by reducing regulatory burden. The order took effect October 9, 2026.
Key points
- Over-the-counter infant pulse rate and oxygen saturation monitor classified class II.Federal Register
- Special controls identified in the order form the codified classification language.Federal Register
- FDA says classification gives reasonable assurance of safety and effectiveness.Federal Register
- Agency expects reduced regulatory burden and wider patient access.Federal Register
- Order effective October 9, 2026; the classification has applied since November 8, 2023. Published as 91 FR 64615.Federal Register
- Amends 21 CFR part 870 (FR Doc. 2026-20726).Federal Register
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RegulationU.S.FDA Class II Classification: Infant Pulse Rate and Oxygen Saturation Monitor for Over-the-Counter Use (2026)HealthcareFor practitionersFor governance