The U.S. Food and Drug Administration has said it will limit regulation of wearable devices and software designed to support healthy lifestyles, issuing new guidance intended to clarify how such products are evaluated. The approach builds on existing policy that categorizes low-risk wellness tools as non-medical devices when they do not make claims related to disease diagnosis or treatment.
According to the FDA, products such as fitness applications and activity trackers that encourage exercise or provide general health information will remain exempt from more stringent regulatory oversight, as long as they avoid positioning themselves as medical-grade technologies. FDA Commissioner Marty Makary said the agency aims to strike a balance between encouraging innovation and ensuring patient safety.
“We have to promote these products and at the same time, just guard against major safety concerns,” Makary said in an interview, referring in part to artificial intelligence-based software used for health-related purposes. He added, “if people are looking up a symptom on an AI-based tool, let's have that conversation when they come in to see their doctor or do a virtual visit.”
Makary emphasized that companies are free to provide information through devices and software without FDA regulation when those tools are positioned clearly as wellness products. “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,” he said.
However, the commissioner noted that limits remain in place when companies claim medical-grade accuracy. “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 said.
The FDA’s stance follows enforcement actions taken last year, including a warning letter to fitness band maker WHOOP. The agency said the company’s blood pressure insights feature blurred the line between wellness and medical devices by estimating systolic and diastolic values typically used to diagnose hypertension. The FDA has also issued broader warnings to consumers about risks associated with unauthorized devices.
The market responded positively to the announcement. 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 rose nearly 3%.
The guidance reflects the FDA’s effort to provide regulatory clarity as wearable technologies and AI-driven health tools continue to expand, while maintaining safeguards against misuse or misinterpretation of health data.
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