The Wearables Tightrope

The modern wearable is no longer a step counter. It is a continuous health interface – an always-on, sensor-based platform that captures physiological signals, interprets them through AI, and translates them into actionable insight. This transformation is fueled by capital investment, rising company valuations, and a broader ambition to build a “personal health OS” that integrates wearable data with clinical records and other biomarker inputs.

Product makers are expanding into new physiological domains associated with healthspan, with companies like Clair Health developing continuous hormone monitoring wearables, while neurotechnology enters wearable form factors through devices like the Muse S headband and Cove. Meanwhile, wearables are becoming critical to longevity-focused research, as evidenced by WHOOP’s participation in the ARPA-H Prospr program – a federally backed initiative to identify markers and develop assessment tools targeting the underlying causes of age-related disease.

The result is a convergence of consumer platforms, biotechnology, and clinical care. It is within this environment that wearable companies must navigate regulatory boundaries never designed for such convergence.

When Does a Wearable Become a Medical Device?

A foundational question every wearable company faces in product development and launch carries significant legal repercussions: is the wearable a medical-grade device?

Under the Federal Food, Drug, and Cosmetic Act (FDCA), a “device” is any instrument “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.” This determination turns on intended use – typically inferred from labeling, marketing claims, and product functionality.

The 21st Century Cures Act, enacted in 2016, introduced a statutory carveout for products “intended for maintaining or encouraging a healthy lifestyle” that present minimal risk to safety. This “general wellness” category has become the primary vehicle through which wearable companies seek to position ever more sophisticated features outside active FDA oversight.

As capabilities expand into blood pressure, cardiac rhythm analysis, and other biomarkers, however, the boundary between lifestyle support and disease-related functionality becomes more challenging to operationalize.

FDA Signals: Clearance, Enforcement, and Evolving Guidance

The US Food and Drug Administration (FDA) has established – through clearance decisions and enforcement – that certain wearable functionalities fall within device regulation. The Apple Watch ECG feature, cleared via the De Novo classification pathway in 2018, marked a key moment in demonstrating that consumer products can incorporate clinically validated functionality subject to FDA oversight.

More recently, the FDA concluded in a 2025 warning letter to WHOOP that the company’s “Blood Pressure Insights” (BPI) feature met the definition of a device because it was “intended for use in the diagnosis of disease or other conditions,” citing blood pressure estimation and cardiovascular health claims. The agency determined the feature required premarket authorization that WHOOP had not obtained.

After WHOOP publicly contested the FDA’s conclusion, the agency issued updated guidance in early 2026 on general wellness products that directly addressed emerging wearable features, including blood pressure tracking. The guidance clarified that products measuring physiological parameters may remain within the wellness category, provided they do not make claims to diagnose, treat, or mitigate disease – emphasizing that the distinction turns on whether outputs are positioned as general insights versus clinical determinations.

The Intersection of Product Classification and Consumer Protection

The WHOOP warning letter has taken on significance beyond the FDA context. In a putative federal class action filed against WHOOP in California in 2025, the plaintiff purchasers of WHOOP products rely directly on the FDA’s conclusions about the BPI feature to support claims that the company misled them about the product’s capabilities and level of validation.

Whether the FDA’s 2026 guidance alters the trajectory of the case remains unclear. Regardless, the litigation presents a critical issue for all wearable companies: how a product is classified under the FDCA has potential consumer protection implications.

That dynamic also invites scrutiny from the Federal Trade Commission (FTC), which evaluates whether health-related claims are truthful and adequately substantiated under separate statutory authority. The FTC can challenge wearable product claims on its own initiative regardless of whether the FDA has taken any action, and FTC enforcement does not depend on FDA findings.

Beyond Devices: Wearables as Care Infrastructure

The closer a wearable approaches medical device territory, the more likely it implicates frameworks governing the practice of medicine. Where a platform delivers individualized health assessments guiding treatment or integrates clinician review, state boards of medicine and attorneys general may view those activities as triggering licensure requirements and corporate practice of medicine restrictions.

Wearables are also beginning to intersect with reimbursement frameworks. Some third-party payers have incorporated consumer wearables into wellness and incentive-based benefit designs – such as activity-based rewards, engagement programs, and supplemental benefit allowances – in which devices like fitness trackers are used to encourage behavior change and generate ongoing health data. At the federal level, the Centers for Medicare & Medicaid Services has signaled growing interest in leveraging digital health infrastructure, including connected consumer devices, in federal health care programs through initiatives like the Health Tech Ecosystem.

In short, wearables are evolving beyond consumer products. They are steadily positioned to serve as the rails on which clinically relevant data flows, payment decisions are made, and care relationships are structured – subject to the compliance expectations that may follow.

Where the Line Goes Next

Offering continuous, AI-driven health insights, wearables are indispensable tools for consumers pursuing whole-person health and extended healthspan. But existing regulatory regimes were designed for episodic, intervention-based care.

Bridging that gap will likely require congressional action to establish categories, clarify standards, and create pathways that account for ongoing monitoring, real-time data streams, and the heightened data security and accuracy obligations they necessitate. One possible model is the proposed THRIVE Act from the Healthspan Action Coalition and Kitalys Institute, which calls for a modernized FDA pathway for “healthspan devices” – products that influence long-term health outcomes without fitting neatly into existing device classifications.

In the meantime, wearable companies must traverse a landscape where regulatory positioning, product design, reimbursement strategy, and liability considerations are tightly intertwined. Both risk and reward turn on anticipating where the line between wellness and medical care is heading – and designing for that future.

Originally published by Longevity.Technology.