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 is exploring how to regulate medical devices that incorporate artificial intelligence (AI) and machine learning (ML), acknowledging that their traditional regulatory framework is not fully equipped for the adaptive nature of these technologies. Traditionally, the FDA regulates medical devices through pathways like premarket clearance (510(k)), De Novo classification, or premarket approval, and also reviews significant modifications to existing devices. However, AI and ML-driven software changes often necessitate a premarket review due to their dynamic nature.

The Food and Drug Administration (FDA) in the US is in charge of ensuring the security of implantable medical devices. There are about thousands of different kinds of devices available, ranging from pacemakers to artificial joints, to brain implants. Many are secure and safe as regulated by the FDA, however, the medical system is not perfect and is a very large business. There are risks associated with all medical device implants, even the most routine ones.