Wearable health devices may soon operate under looser regulatory oversight following new guidance from the U.S. Food and Drug Administration (FDA). The agency said Tuesday that it will limit regulation of wearable devices and software designed to support healthy lifestyles, aiming to clarify how it approaches oversight in this rapidly growing sector.
“We want to let companies know, with very clear guidance, that if their device or software is simply providing information, they can do that without FDA regulation,” FDA Commissioner Marty Makary told Fox Business.
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“The only stipulation is if they make claims of something being medical grade … like blood pressure measurement. We don’t want people changing their medicines based on something that’s just a screening tool or an estimate of a physiologic parameter,” Makary added.
The announcement was welcomed by investors. Shares of continuous glucose monitor manufacturers Abbott, Medtronic, and Dexcom closed between 1% and 4% higher, while U.S.-listed shares of fitness smartwatch maker Garmin ended the day nearly 3% higher.
What is the U.S. Food and Drug Administration?
The U.S. Food and Drug Administration (FDA) is a federal agency within the Department of Health and Human Services responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, vaccines, medical devices, food, cosmetics, and radiation-emitting products. Established in 1906 following the passage of the Food and Drugs Act, the agency has since expanded its oversight to cover a broad range of products essential to daily life.
The FDA evaluates new drugs and medical devices before they reach the market, monitors post-market safety, and enforces labeling standards to ensure consumers receive accurate and reliable information. It also regulates food safety, oversees dietary supplements, and works to prevent contamination and foodborne illness. During public health emergencies, the agency may issue emergency use authorizations, allowing faster access to potentially life-saving medical products.
Beyond its regulatory role, the FDA conducts research, issues guidance to manufacturers, and collaborates with international partners to uphold health and safety standards. Its decisions can influence innovation, public trust, and healthcare outcomes. By balancing safety, efficacy, and timely access, the FDA plays a central role in safeguarding public health, though public perception of the agency may fluctuate over time.
What are wearable health devices?
Wearable health devices are electronic products worn on the body to monitor, track, or support health and fitness. These devices collect real-time data on physiological functions or activity levels, helping individuals—and sometimes healthcare professionals—make more informed decisions. Common examples include smartwatches and fitness trackers that monitor steps, heart rate, sleep patterns, and calorie expenditure; continuous glucose monitors that track blood sugar levels; and wearable ECG devices designed to detect irregular heart rhythms. More advanced products include smart clothing or adhesive patches that measure respiration, muscle activity, or posture.
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Most wearable devices rely on sensors such as accelerometers, optical sensors, or electrodes to collect data, which is typically synced to a smartphone or cloud-based platform for analysis and visualization. Potential benefits include early detection of health issues, improved management of chronic conditions, encouragement of healthier habits, and personalized fitness insights.
By drawing a clearer line between general wellness tools and medical-grade devices, the FDA says it aims to encourage innovation while protecting consumers from potential misuse or misinterpretation of health data.