The U.S. Food and Drug Administration (FDA) released its 2026 guidance on Low-Risk General Wellness Devices on January 6, replacing the 2019 version and bringing much-needed clarity to how wellness technologies should be designed and marketed in today’s digital health ecosystem. The document is short, but its implications stretch across fitness bands, smartwatches, health apps, and even AI-driven coaching platforms that sit at the edge of healthcare.
The core policy remains unchanged: the FDA does not intend to regulate low-risk general wellness devices as medical devices, provided they are: (i) intended solely for general wellness use (such as promoting healthy lifestyles or fitness) and (ii) present low risk to the safety of users or others.
The updated guidance introduces material clarifications mainly aimed at non-invasive wearable technology in the consumer health space. In effect, it draws a sharper, better-defined boundary between wellness and medical devices – a distinction that will shape the direction of digital health innovation in 2026 and beyond.
Defining “Wellness” More Clearly
The FDA now provides a far more explicit interpretation of where the “general wellness” category ends. The guidance states that devices may collect physiological data such as blood pressure, oxygen saturation, glucose, heart rate variability, and still qualify as general wellness tools, as long as it:
- is non-invasive and not-implanted;
- does not pose a safety risk if specific regulatory controls are not applied;
- is not intended for the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition;
- is not intended to substitute for an FDA-authorized, cleared, or approved device;
- does not include claims, functionality, or outputs that prompt or guide specific clinical action or medical management; and
- does not include values that mimic those used clinically unless validated (e.g. manufacturer testing, peer-reviewed clinical literature) to reflect those values.
This means, for example, that a smartwatch that tracks heart rate variability and offers stress-management tips can remain on the “wellness” side of the line, so long as it avoids implying that it detects anxiety disorders, arrhythmias, or other diagnosable conditions.
From a regulatory perspective, these distinctions are increasingly being scrutinized not just by product teams, but also by healthcare & life sciences lawyers advising digital health companies on how product design, data presentation, and user messaging can influence FDA oversight.
Crossing The Line
A product loses its low-risk status if it does not limit itself to general health purposes, and crosses into clinical territory. The new guidance identifies several disqualifying factors, including:
- Making clinical or therapeutic claims.
- Offering medical management prompts or treatment suggestions.
- Referencing specific diseases or medical conditions.
- Displaying alerts for “abnormal” results.
- Using a user interface resembling clinical monitoring tools.
The guidance clarifies that wellness products can include prompts advising users to consult a healthcare professional when data raises concerns, as long as those notifications avoid naming diseases, labelling results as abnormal or diagnostic, or referencing clinical thresholds or specific recommendations.
The guidance further flags labelling, advertising, user interfaces, and features that push a product into regulated medical device territory, such as mentions of specific diseases, clinical thresholds, treatment guidance, claims of equivalence to clinical tools, or statements positioning the product for diagnosis, screening, monitoring, or disease management.
Put simply, the FDA draws a line between data that informs general wellness and data that interprets or intervenes in health decisions – a boundary that developers must now navigate with greater precision. This makes wording, UX, and even visual design decisions part of a company’s regulatory risk profile, not just marketing choices.
Lessons From Whoop and Recent Precedents
The broader context for these updates includes recent regulatory debates over next-generation wearables. The FDA’s 2025 warning letter to Whoop, which found that its Blood Pressure Insights feature constituted an unapproved medical device, brought this issue squarely to the forefront.
Whoop argued that its feature delivered general feedback rather than diagnostic analysis, sparking industry-wide concern over regulatory ambiguity. For many founders and investors, the Whoop letter raised difficult questions: how much interpretation is too much, and when does an “insight” become a diagnosis?
The message is not that innovation in biomarker-based coaching is unwelcome; rather, it is that once a product appears to make clinical judgments about those biomarkers, it moves into the realm of regulated medical devices. For companies building AI-driven “insight engines,” this context will be crucial in designing both their algorithms and the way outputs are framed to users.
Alignment With Broader Federal Health Strategy
The 2026 update also aligns with the U.S. administration’s broader push to integrate digital health tools responsibly into care delivery systems. Programs like:
- The Centers for Medicare & Medicaid Services (CMS) ACCESS Program, which encourages digital health adoption for expanded access and engagement.
- The FDA TEMPO Pilot, which supports development of tech-enabled platforms that complement existing clinical practices.
Together, these initiatives reflect an evolving approach, one that invites wearables into the healthcare conversation without automatically subjecting them to medical device regulation. Policymakers appear to be aiming for a middle path: creating room for wellness technologies to support prevention, self-management, and behaviour change, while reserving stricter oversight for tools that effectively function as medical devices.
Looking Ahead
For developers, the 2026 guidance provides a clearer compliance roadmap but also raises the bar for internal diligence. Companies should:
- Audit labelling, marketing, and app content to ensure language does not imply diagnosis or treatment.
- Re-examine user interface design to avoid clinical aesthetics or “abnormal” result flags.
- Maintain transparent disclaimers differentiating general wellness insights from medical advice.
Consumers, meanwhile, can expect more refined and responsible products – tools that support self-awareness and healthy habits without crossing into unregulated medical advice territory. If implemented well, this guidance should lead to clearer on-screen explanations of what a device can and cannot do, helping users distinguish between wellness nudges and information that belongs in a doctor’s office. For companies operating at this intersection, early engagement with a best technology law firm can play a critical role in aligning innovation with evolving regulatory expectations.
Authors: Shantanu Mukherjee, Varun Alase
