FDA classifies infant pulse rate and oxygen saturation monitor as class II
The order assigns the device to class II, adding special controls to the codified language. The action is expected to enhance patients' access to beneficial innovative devices by reducing regulatory burdens.
Primary source
Federal Register rule, October 9, 2026
Medical Devices; Cardiovascular Devices; Classification of the Infant Pulse Rate and Oxygen Saturation Monitor for Over-the-Counter Use
Read the source: Medical Devices; Cardiovascular Devices; Classification of the Infant Pulse Rate and Oxygen Saturation Monitor for Over-the-Counter Use federalregister.gov
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