As new consumer hardware and software capabilities have bumped up against medicine over the last few years, consumers and manufacturers alike have struggled with identifying the line between “wellness” products such as earbuds that can also amplify and clarify surrounding speakers’ voices and regulated medical devices such as conventional hearing aids. On January 6, 2026, the U.S. Food and Drug Administration issued new guidance documents clarifying how it interprets existing law for the review of wearable and AI-assisted devices.
The first document, for general wellness, specifies that the FDA will interpret noninvasive sensors such as sleep trackers or heart rate monitors as low-risk wellness devices while treating invasive devices under conventional regulations. The other document defines how the FDA will exempt clinical decision support tools from medical device regulations, limiting such software to analyzing existing data rather than extracting data from sensors, and requiring them to enable independent review of their recommendations. The documents do not rewrite any statutes, but they refine interpretation of existing law, compared to the 2019 and 2022 documents they replace. They offer a fresh lens on how regulators see technology that sits at the intersection of consumer electronics, software, and medicine—a category many other countries are choosing to regulate more strictly rather than less.
What the 2026 update changed
The 2026 FDA update clarifies how it distinguishes between “medical information” and systems that measure physiological “signals” or “patterns.” Earlier guidance discussed these concepts more generally, but the new version defines signal-measuring systems as those that collect continuous, near-continuous, or streaming data from the body for medical purposes, such as home devices transmitting blood pressure, oxygen saturation, or heart rate to clinicians. It gives more concrete examples, like a blood glucose lab result as medical information versus continuous glucose monitor readings as signals or patterns.
The updated guidance also sharpens examples of what counts as medical information that software may display, analyze, or print. These include radiology reports or summaries from legally marketed software, ECG reports annotated by clinicians, blood pressure results from cleared devices, and lab results stored in electronic health records.
In addition, the 2026 update softens FDA’s earlier stance on clinical decision tools that offer only one recommendation. While prior guidance suggested tools needed to present multiple options to avoid regulation, FDA now indicates that a single recommendation may be acceptable if only one option is clinically appropriate, though it does not define how that determination will be made.
Separately, updates to the general wellness guidance clarify that some non-invasive wearables—such as optical sensors estimating blood glucose for wellness or nutrition awareness—may qualify as general wellness products, while more invasive technologies would not.
Wellness still requires accuracy
For designers of wearable health devices, the practical implications go well beyond what label you choose. “Calling something ‘wellness’ doesn’t reduce the need for rigorous validation,” says Omer Inan, a medical device technology researcher at the Georgia Tech School of Electrical and Computer Engineering. A wearable that reports blood pressure inaccurately could lead a user to conclude that their values are normal when they are not—potentially influencing decisions about seeking clinical care.
“In my opinion, engineers designing devices to deliver health and wellness information to consumers should not change their approach based on this new guidance,” says Inan. Certain measurements—such as blood pressure or glucose—carry real medical consequences regardless of how they’re branded, Inan notes.
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