The FDA will not regulate wearable devices that provide nonmedical-grade health information, a move aimed at giving technology companies clearer guidance as AI-driven health tools proliferate, Fox Business reported Jan. 6.
FDA Commissioner Marty Makary, MD, announced the shift during an interview on Varney & Co., saying devices and software that offer general health information, rather than clinical-grade measurements, can operate without FDA oversight.
“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,” Dr. Makary said, according to Fox Business.
The exemption applies as long as companies do not market their products as medical-grade or clinically appropriate, Dr. Makary said. Devices that claim to provide clinical blood pressure readings or other diagnostic-level measurements would still fall under FDA regulation.
The distinction is intended to prevent patients from making medical decisions based on estimates or screening tools, Dr. Makary said.
“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 said.
The clarification comes as the FDA seeks to adapt to rapid advancements in AI and digital health technologies. Dr. Makary told Fox Business the agency must take a more proactive approach as innovation accelerates.
The policy is also expected to offer more predictability for companies and investors navigating the wearable health technology market.
When asked about the accuracy of nonmedical-grade wearables, Dr. Makary said the marketplace, not regulators, should determine which products succeed. He said physicians can choose from a competitive range of tools when deciding what to recommend to patients.
Dr. Makary also referenced new FDA guidance released Jan. 6 related to AI-powered support tools such as Google and ChatGPT. He said the agency does not plan to regulate platforms that simply provide information, even if some outputs may be inaccurate.
“If something is simply providing information like ChatGPT or Google, we’re not going to outrun that lion,” Dr. Makary said, according to Fox Business. “We have to promote these products and, at the same time, just guard against major safety concerns.”
