The FDA issued a critical safety communication on September 16, 2025, advising against the use of unauthorized infant devices designed to monitor vital signs such as heart rate, oxygen saturation, respiratory rate, and body temperature. This announcement is directed at parents, caregivers, and health care providers, emphasizing the risks of inaccurate measurements and delayed treatment that these devices may pose.
What Are Infant Monitors?
Infant monitors are devices intended to track vital signs and notify caregivers if measurements fall outside preset thresholds. Many of these devices are marketed as wearable items, such as foot or belly monitors, or contactless setups like mattress sensors and camera-based systems. The goal of these devices is to prompt intervention, such as contacting a health care provider or seeking emergency care when concerning signals are detected.
Why Is the FDA Acting?
The FDA has found that many over-the-counter infant monitors available on the market lack FDA marketing authorization. This means the agency has not assessed their safety or effectiveness. Unauthorized devices may provide inaccurate data that can lead to both unnecessary medical procedures or delayed care for serious symptoms. Furthermore, no infant monitoring device has been authorized by the FDA to prevent Sudden Infant Death Syndrome (SIDS) or Sudden Unexpected Infant Death (SUID).
The agency highlighted that products claiming to prevent SIDS or SUID are misleading and unsupported by clinical or scientific evidence. Safe sleep practices and adult supervision remain the cornerstone of infant care.
Risks of Unauthorized Devices
Using unauthorized infant monitors can lead to multiple risks, including:
- Failure to detect critical changes in heart rate, oxygen levels, breathing, or temperature.
- Delays in seeking treatment due to reliance on unreliable alerts.
- Adverse tissue reactions, including burns or rashes caused by wearable devices.
- Unnecessary medical interventions prompted by incorrect measurements.
Parents and caregivers are advised to choose FDA-authorized devices for infant monitoring when medical decisions depend on accurate data. Devices authorized by the FDA can be identified through the De Novo and 510(k) databases, where products with the code QYU appear.
Are These Devices Low Risk?
Infant monitors marketed for vital sign tracking do not qualify as general wellness products. These devices are categorized as higher-risk and must undergo evaluation by the FDA to obtain lawful marketing authorization in the United States.
What Should You Do?
If you currently use or are considering purchasing an infant vital sign tracking device, the FDA advises the following:
- Avoid devices claiming to monitor heart rate, respiratory rate, oxygen saturation, and body temperature unless they are FDA-authorized.
- Steer clear of products claiming to prevent SIDS or SUID, as no such device has FDA approval for these uses.
- Use the FDA’s De Novo and 510(k) databases to verify whether a device has received marketing authorization under the product code QYU.
- Discuss monitoring needs with health care providers to identify appropriate FDA-authorized options.
Reporting Issues
If you experience any problems due to inaccurate measurements or adverse events arising from the use of unauthorized infant monitors, report these incidents to the FDA using the MedWatch Voluntary Reporting Form. Health care personnel should follow facility-based reporting protocols. Prompt reports help the FDA enhance safety monitoring and regulatory actions.
Manufacturer Actions
As part of its regulatory oversight, the FDA monitors the medical device market for unauthorized products and takes steps to manage unlawfully marketed devices. The agency is committed to balancing innovation in digital health with a strong focus on patient safety.
Conclusion
Parents, caregivers, and health care providers should avoid reliance on unauthorized infant vital sign monitors due to significant safety and effectiveness concerns. Always consult with medical professionals to ensure the use of FDA-authorized devices that meet your child’s health requirements.
Disclaimer
This post is intended for informational purposes only and is not legal advice. Always consult regulatory professionals for compliance-related matters.
Mandatory FDA Line
For full information about the FDA announcement, see the link below.