The Food and Drug Administration has codified testing and labeling controls for over-the-counter monitors that measure infants' pulse rate and oxygen saturation. Its order takes effect October 9, 2026, but the classification it writes into the regulations was applicable on November 8, 2023.
What the order does
FDA says it granted the earlier classification after reviewing Owlet Baby Care's request for its Dream Sock device. The new order adds the generic device category to 21 CFR 870.2705 as class II, which requires general safeguards and additional controls specific to the device.
The category covers devices that use light-based sensing, called photoplethysmography, to measure pulse and oxygen saturation. They may include alarms when readings go outside preset thresholds. The publication is a codification of that category, not an announcement that a new monitor has just been approved.
Readings and the person interpreting them
Clinical testing must demonstrate performance under expected conditions of use. It must evaluate factors such as skin pigmentation, whether the data represent the intended users and settings, and adverse events including skin irritation.
The controls also require software verification and hazard analysis, checks on incoming sensor-data quality, alarm validation, electrical safety and compatibility testing, and evaluation of components touching the skin.
Caregiver understanding is a separate requirement. Usability testing must show that caregivers can use the device from its labeling alone, correctly interpret its outputs and understand the next steps to take.
Limits belong in the instructions
The label must identify intended users, populations in which the device should not be used, and conditions of monitoring. It must explain what the device measures, how to interpret results, appropriate actions, circumstances in which performance may fall short, and cleaning instructions.
FDA identifies over-reliance on readings that delays treatment despite acute symptoms as one risk, alongside false positive and false negative readings. The order requires controls to address those risks; it does not eliminate them or recommend a particular product to families.
The device category remains subject to FDA's premarket notification process, known as 510(k). FDA has not exempted it from that requirement.