Fitness wearables have come a long way from the Manpo-Kei or “ten thousand steps” pedometer, which debuted in Tokyo in 1965 as the first-ever wearable health device and the forefather of the personal fitness tracking or ‘biohacking’ industry. Today, the global wearable technology market size is valued at USD 92.9 billion in 2025 and is projected to grow from USD 103.1 billion in 2026 to USD 229.9 billion by 2033, at a CAGR of 12.1%.
Technological advancements that have made such wearables more compact and efficient, coupled with an increased demand for remote monitoring and personalised care, have driven the explosive growth of the fitness wearable industry.
A wristband, watch, or ring to track an ever-growing range of biomarkers, for every man, woman and child on the planet? It could be a reality within years, not decades.
Consumer Wearable or Medical Device?
Most wearable devices today are designed and used to identify key biomarkers in the human body, such as heart rate, body temperature, calorie intake, workouts, etc., which assist in monitoring or preventing diseases. For instance, the Apple Watch lineup features an integrated ECG function, blood oxygen sensors, and advanced temperature tracking sensors. Samsung, one of Apple’s competitors, has similarly embedded an ECG function and blood pressure monitors in its smartwatches. In addition to heart rate, sleep, and oxygen levels, Fitbit allows one to track and manage stress by calculating heart rate variability at different times of the day.
Further broadening the market, WHOOP has emerged as a major player focusing on continuous physiological metrics, tracking key biomarkers like resting heart rate, heart rate variability (HRV), respiratory rate, skin temperature, and sleep staging to calculate an individual’s daily strain and recovery. WHOOP has also expanded into integration with specialised metabolic, hormonal, and performance blood panels to analyse external digital biometrics alongside standard operational stats.
Meanwhile, Oura continues to offer its smart ring to provide in-depth analysis of sleep and health habits. Beyond general fitness tracking, the continuous tracking of metabolic biomarkers has seen a massive surge, driven by continuous glucose monitoring (CGM). Startups such as Supersapiens and Levels Health allow users to sync wearable continuous blood glucose monitors directly to specialised apps, facilitating real-time blood sugar management and dietary optimisation.
As wearables become more sophisticated, enabling them to monitor and analyse vital signs and pre-empt diseases, the line between a consumer and patient, and that of a wearable versus a medical device, gets blurred, giving rise to various challenges.
How does the FDA Regulate Wearables?
The 1938 Federal Food, Drug, and Cosmetic Act (FDCA) empowers the FDA to oversee medical devices. Under Section 201(h), a medical device is defined as an instrument intended for the diagnosis, cure, mitigation, treatment, or prevention of disease. However, Section 520(o)(1)(B) explicitly excludes software intended solely for maintaining or encouraging a healthy lifestyle from this definition. To clarify the grey area between consumer wearables and medical devices, the FDA issued its non-binding General Wellness: Policy for Low-Risk Devices guidance in July 2016, which was subsequently updated in January 2026.
The FDA guidance defines a general wellness product as one that meets the following criteria: it is intended only for general wellness use, and it is of low risk to the safety of its users and other persons.
The FDA has created two categories of intended uses to determine the nature of wearables, including for (i) general health and lifestyle, and (ii) disease-specific devices. It does not heavily penalise or regulate low-risk products that support overall well-being or assist users in managing life with a pre-existing condition, provided they do not make explicit, direct claims to cure, treat, or structurally alter the body.
What is the Key Determinant, Function or Form?
The FDA’s General Wellness Guidance applies only to low-risk products that are not invasive, implantable, or reliant on technologies that could pose safety risks (such as lasers or radiation), intended as general wellness products, may be regulated as medical devices if they fail the criteria.
While the guidance reduces regulatory burdens for low-risk wellness wearables and foster innovation, the FDA assesses products based on both their intended use and actual functionality, meaning that features performing medical device functions may still require regulatory approval despite being marketed for wellness purposes.
This distinction is illustrated by a wrist-worn wearable product intended to assess activity and recovery that outputs multiple biomarkers like hours slept, sleep quality, pulse rate, and blood pressure using non-invasive technology, which will be classified as a low-risk general wellness product. Whereas a wearable product intended to provide blood glucose estimation for monitoring nutritional impacts using a minimally invasive microneedle technology would not be classified as low risk, as it is invasive and therefore a medical device.
Conclusion
The FDA’s 2026 General Wellness Guidance provides greater regulatory certainty for consumer health technologies by reaffirming that only products intended solely for general wellness and presenting a low risk to users qualify for enforcement discretion, while introducing clearer rules for non-invasive physiological sensors. The guidance also clarifies that devices presenting a higher risk by incorporating invasive technologies, implants, radiation, disease-specific claims, or features that guide clinical decision-making remain subject to medical device regulation, regardless of how they are marketed. Ultimately, the update reinforces the FDA’s holistic approach to regulation, making clear that a wearable’s classification depends not only on its technology but also on its intended use, functionality, labelling, in-app content, and promotional claims.
Authors: Shantanu Mukherjee, Shruti Gupta, Maitreyi Ramdas
