FDA Warns Against Using Unauthorized Smartwatches and Rings for Blood Glucose Measurement

The FDA has not authorized, cleared, or approved any smartwatch or smart ring

The U.S. Food and Drug Administration (FDA) has issued a safety communication advising against the use of smartwatches or smart rings that claim to measure blood glucose levels without piercing the skin. This warning is directed at consumers, patients, caregivers, and healthcare providers, emphasizing that the FDA has not authorized, cleared, or approved any such devices for this purpose. The alert distinguishes these products from smartwatch applications that display data from FDA-authorized devices, such as continuous glucose monitoring devices (CGMs), which do require skin piercing. The FDA's concern stems from the potential for inaccurate blood glucose measurements provided by these unauthorized devices, which could lead to serious errors in diabetes management. Such inaccuracies could result in taking incorrect doses of insulin or other medications, leading to dangerously low glucose levels, mental confusion, coma, or even death.

The FDA strongly recommends against purchasing or using smartwatches or smart rings that claim to measure blood glucose levels, as their safety and effectiveness have not been reviewed. Consumers are advised to consult healthcare providers for FDA-authorized devices that accurately measure blood glucose. Healthcare providers are also urged to inform their patients about the risks associated with using these unauthorized devices and to assist them in selecting an appropriate, FDA-authorized device for their needs. The communication covers any device claiming to measure blood glucose non-invasively, regardless of the manufacturer or brand, due to the devices not directly testing blood glucose levels but claiming to do so through non-invasive techniques.

In response to the emergence of these unauthorized products on the market, the FDA is taking action to prevent the illegal marketing of these devices and is alerting the public to their potential risks. The agency encourages reporting of any problems or adverse events experienced with these unauthorized devices through the MedWatch Voluntary Reporting Form. This effort is part of the FDA's ongoing commitment to monitor the medical device market and ensure the safety and efficacy of medical devices available to consumers. The FDA promises to keep the public informed of any significant new information regarding these devices.