Dive Brief:
- The Food and Drug Administration posted two notices on Tuesday warning about unauthorized blood pressure and infant monitoring devices sold over the counter.
- Many devices for measuring blood pressure and monitoring infant vital signs are currently sold over the counter without FDA marketing authorization, the agency said. The FDA recommended looking for an authorized device.
- The regulator has sent warning letters in the past to companies for selling monitoring devices without authorization.
Dive Insight:
The FDA sent a warning letter in July to Whoop, a company making a wellness wristband, for marketing an unauthorized blood pressure insights feature. Whoop has since pushed back on the warning letter, indicating last month that it does not plan to disable the feature.
Similarly, in 2021, the FDA sent a warning letter to Owlet for selling “smart socks” to track health metrics for babies, such as oxygen saturation and heart rate. Owlet pulled the device from the market and reintroduced it two years later after receiving the FDA’s de novo authorization.
The FDA said it sent the pair of notices on Tuesday after it “became aware of unauthorized products being marketed to consumers through routine monitoring of the medical device market.”
The FDA warned patients not to use unauthorized devices that claim to measure or estimate blood pressure. These can include software features on wearables, such as smartwatches and smart rings, the agency said. Because high blood pressure often has no physical symptoms, accurate measurements are critical, the FDA said. Inaccurate blood pressure measurements can lead to problems with diagnosing hypertension or low blood pressure, which can result in delayed treatment or lack of treatment.
In a separate notice, the agency instructed patients to avoid unauthorized infant monitors for measuring vital signs, such as heart rate, oxygen saturation, breathing and body temperature. Infant monitors are designed to alert caregivers when values are outside of set ranges, so they can call a doctor or seek emergency care. Inaccurate measurements could lead to unnecessary medical care or delayed treatment.
Devices on the market have not been evaluated to support monitoring for asthma, apnea, sudden infant death syndrome or the overall health condition of infants, the FDA said, adding that infant monitors are also not a replacement for adult supervision and safe sleep practices.
To see if the FDA has authorized specific devices , the agency said to search its 510(k) and de novo databases for devices with the product codes “DXN” for blood pressure and “QYU” for infant monitoring.
