Regulating Wellness and Medical Wearables in an Age of Blurring Boundaries

Wearable devices — smartwatches, fitness bands, continuous glucose monitors, sleep trackers — are poised to play a growing role in public health. In the U.S., 30 percent of adults own a smart watch or fitness tracker. Globally, the total population using these devices exceeds 500 million.

Growing public interest in lifestyle-based chronic disease prevention, combined with rapid advances in sensor technology and machine learning, has transformed these products from novelty gadgets into sophisticated health monitoring tools. For Contract linical Research Organizations (CRO), device manufacturers, and regulatory professionals, understanding the evolving regulatory climate is now a business-critical priority.

The U.S. Federal government has demonstrated a growing interest in the potential for devices to address problems with access and chronic disease treatment. In 2024, the FDA launched a Home as Health Care Hub. This featured collaboration among medical device manufacturers, health care providers, and diabetes patients to imagine digital solutions in a home setting.

The pro-device sentiment has accelerated with the political tailwinds of the past 12 months, bolstered by a coalition of advocates, including Silicon Valley venture capital and the Make America Healthy Again movement.

Since becoming Secretary of Health and Human Services, Robert F. Kennedy Jr. has called for every American to own a wearable within four years. His agencies also announced plans for the Centers for Medicare and Medicaid Services (CMS) to reimburse providers for using devices with patients. Independent of the political context, the policy signals are real and worth monitoring.

Changing Technology and Usage Patterns

Two trends define the regulatory challenge. The first is the expansion of wearable use beyond the original, narrowly defined populations. Continuous Glucose Monitors (CGMs) were once exclusively prescribed for patients with diabetes. In recent years, they have found broad adoption among non-diabetics as tools for monitoring diet, exercise, and metabolic stress.

“I believe CGM is the most powerful technology for generating the data and awareness to rectify our Bad Energy crisis in the Western world,” writes Casey Means in her book Good Energy. Means is the CEO of the Andreessen Horowitz-funded startup Levels, and the Trump nominee for Surgeon General (although not yet confirmed by the Senate). She is one of many lifestyle health entrepreneurs who have recently gained power and influence in policy decisions, advocating device usage for all-purpose applications that transcend any single disease state.

The second trend is the increasing technical sophistication of the devices themselves. A decade ago, wearables offered little more than step counts and calorie estimates derived from general population averages. Improvements in sensor technology and machine learning now enable personalized insights drawn from continuous, individual-level data streams. Heart rate variability, blood oxygen saturation, skin temperature trends, and sleep architecture are among the metrics now routinely surfaced by consumer devices — outputs that, in a clinical context, would be considered diagnostically meaningful.

Together, these trends put increasing pressure on the traditional binary framework that the FDA had used to evaluate devices. As Oura CEO, Tom Hale, observed in a Wall Street Journal editorial: "The FDA categorizes them and their associated software in two categories: general wellness products and medical devices. The former have minimal oversight and no standards. The latter — products intended to diagnose, treat or prevent disease — must meet requirements for design, labeling, and manufacturing." The problem, as the industry was about to discover, is that a growing number of products fit neither category cleanly.

The Whoop Dustup — and What It Revealed

The tension in these ambiguities came to a head with the FDA's 2025 warning letter to Whoop for a blood pressure feature it described as an unapproved medical device — a decision the company aggressively disputed. Whoop had launched "Blood Pressure Insights" in 2024 with an explicit warning statement that the feature did not measure blood pressure or diagnose hypertension. The name of the feature told a different story. Clinicians and regulators argued that users would reasonably interpret the feature as a blood pressure measurement based on the product's user interface and in-app messaging. This, they asserted, posed risks of both false reassurance and unnecessary clinical anxiety.

The case crystallized a principle that has since become central to the FDA's updated approach: what a product says in its fine print matters far less than what a user reasonably understands it to do.

once-niche application now promoted for mainstream use

The FDA's Updated Guidance: Four Key Signals

The Whoop incident and similar controversies catalyzed a policy response. In January 2026, the FDA updated its general guidance on wearables. The update did not resolve every ambiguity — and was not designed to — but it sends four clear signals to the industry.

1. A middle tier is real, even without a formal classification.

The FDA reaffirmed that it does not intend to regulate low-risk general wellness products that are non-invasive, not implanted, and pose low risk to users. Crucially, however, it also formally acknowledged what many in the industry had long argued: a meaningful middle tier of devices exists between "general wellness" and "medical device." This tier includes wearables that generate real-world evidence and have the potential to influence care decisions without crossing into diagnosis or treatment. The FDA has not yet created a formal classification. The "digital health screener" category proposed by Oura's Tom Hale remains aspirational. Nonetheless, the agency has validated the concept and signaled a willingness to engage with innovators operating in this space.

2. Disclaimers are not a regulatory strategy.

The FDA has made clear that it evaluates wearable features based on user perception, not fine-print intent. A feature named "Blood Pressure Insights" will be scrutinized as a blood pressure tool regardless of what the accompanying disclaimer says. For manufacturers, this means that product branding, user interface design, data presentation, and consumer communication are regulatory decisions, not just marketing ones. Regulatory review needs to be integrated into the product design process from the start, not layered on at the end.

3. Enforcement discretion is strategic and conditional — not a free pass.

The agency has signaled a willingness to exercise enforcement discretion for middle-tier wearables under defined conditions, particularly in the context of structured real-world evidence generation. This is not a blanket exemption. It is a conditional posture tied to specific programs and specific commitments around data quality and clinical rigor. Whoop received a degree of regulatory latitude given the prior ambiguity in guidance; manufacturers should not expect the same flexibility going forward.

4. Two new federal programs — ACCESS and TEMPO — are opening a structured pathway.

The most significant long-term development in the updated guidance is the launch of two complementary federal programs. The CMS ACCESS Model (Advancing Chronic Care with Effective, Scalable Solutions), announced in late 2025, expands technology-enabled care for patients with chronic conditions — with a specific emphasis on remote wearables and digital monitoring for diabetes, hypertension, and chronic pain — and introduces reimbursement mechanisms for qualifying devices.

Paired with ACCESS is the FDA's TEMPO program (Technology-Enabled Meaningful Patient Outcomes), which offers select wearable manufacturers enforcement discretion from premarket authorization requirements while their products are used with real-world patients within the ACCESS framework. Together, these programs create a structured pathway for middle-tier wearables to generate clinical evidence, establish reimbursement eligibility, and build regulatory credibility — without first navigating the full 510(k) or De Novo process.

Implications for CROs and Manufacturers

The updated guidance does not offer the comprehensive classification framework many in the industry hoped to receive. Given how rapidly the boundaries between "medical" and "general wellness" are shifting in society at large, perfect regulatory clarity was probably never a realistic expectation. What the guidance does offer is a set of clear strategic signals:

1. Treat user perception as a regulatory input, not a marketing variable.

Whoop received some latitude given the prior ambiguity in guidance. Do not expect that accommodation going forward. Product naming, interface design, data visualization, and consumer messaging should be developed with regulatory review integrated into the process — not appended afterward. If a feature could reasonably be interpreted as diagnostic by a non-clinical user, it will be evaluated as such.

2. Make the ACCESS/TEMPO decision before product features are locked.

The FDA has not created a formal digital health screener classification, but it has validated the middle tier and provided a structured pathway through TEMPO. Manufacturers need to decide early whether to pursue TEMPO enrollment for structured real-world evidence generation or to pursue formal 510(k)/De Novo clearance — and that decision should inform feature scope, labeling strategy, and clinical study design from the outset. Treating it as a downstream regulatory question is a costly mistake.

3. Real-world evidence is becoming a strategic asset — build the infrastructure now.

The ACCESS and TEMPO programs signal a future in which structured real-world data generated by wearables can support both regulatory submissions and reimbursement eligibility. Organizations that establish data integrity protocols, define clinical endpoints, and build RWE infrastructure now will be significantly better positioned when middle-tier wearables are formally integrated into reimbursement models. A hybrid clinical-digital study strategy developed in advance of that transition — rather than in response to it — is likely to be a durable competitive advantage.

Conclusion

Wearable device manufacturers and their clinical regulatory partners are well-positioned to play a defining role in transforming U.S. public health over the next decade. The secular trends supporting them — growing consumer interest in lifestyle-based prevention, increasing sophistication of biosensor technology, and meaningful engagement from federal regulators and payors — are structural, not cyclical.

The boundaries between wellness and medicine are not disappearing. But they are converging — and the space between them is becoming both more contested and more commercially significant. The organizations that understand the regulatory terrain at that intersection now and build their product, clinical, and data strategies accordingly will be best placed to define what comes next.