FDA Commissioner Marty Makary reported new policies on wearable devices. According to the policy on wearable devices, non-medical-grade information will no longer need to follow FDA regulation as they reframed and provided more clarity with their approach to digital health and artificial intelligence.
According to Dr. Makary, “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 added, “The only stipulation is if they make claims of something being medical grade, like a clinically appropriate, clinical grade 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,” he added.
Digital Health Regulation 2026
The changes to the FDA policy on wearable devices is to provide a more clear guidance for the healthcare industry and a better understanding for investors.
The reason for this clarification is due to the rapid pace of artificial intelligence and technological advancements that the government agencies are unable to manage.
Wearable Health Tech Regulation
Makary wants the FDA to be more proactive. According to him the decision on whether the wearables provide accurate measurements pr not should be left to the market for non-medical-grade devices.
The new FDA guidance shall provide the wearable tech a clear picture on the types of claims it can make. From now on, FDA is not going to take action against a feature that describes a physiological measurement based solely on that measurement being an indicator for an unstated disease. Companies can avoid disease claims by being clear that the device is not intended to diagnose disease and the product is not a substitute for FDA-cleared products as well as does not prompt or guide specific clinical action or medical management based on the blood pressure data.
New guidance for ChatGPT
On Tuesday, FDA announced new guidance regarding support tools such as Google and ChatGPT.
Markary said, “If something is simply providing information like ChatGPT or Google, we’re not going to outrun that lion. We’re not going to go in there and say, ‘There’s one result that is inaccurate, therefore we’ve got to shut this down'”.
Though new policies came about there is still a blurry line between regulated and unregulated, there is still a lot of gray area that requires careful consideration before any wearable company has a feature to market that measures a user’s health data.
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