Data / Federal rules / 2026-20726
Medical Devices; Cardiovascular Devices; Classification of the Infant Pulse Rate and Oxygen Saturation Monitor for Over-the-Counter Use
The Food and Drug Administration published this final rule in the Federal Register on October 9, 2026. It took effect on October 9, 2026.
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What the agency says
The Food and Drug Administration (FDA) is classifying the infant pulse rate and oxygen saturation monitor for over-the-counter use into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the infant pulse rate and oxygen saturation monitor for over-the-counter use. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Key facts
- Document number
- 2026-20726
- Type
- Final rule
- Action
- Final amendment; final order
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- October 9, 2026
- Takes effect
- October 9, 2026
- Dates
- This order is effective October 9, 2026. The classification was applicable on November 8, 2023.
- Docket
- Docket No. FDA-2026-N-10993
- Code of Federal Regulations
- 21 CFR 870
- Topics
- Medical devices
- Pages
- 3
Other documents from the Food and Drug Administration
Everything from the Food and Drug Administration · Rules on medical devices · Published in October 2026
Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.