FDA’s New Guidance on Consumer Wearables Makes the Medtech Market More Complex

Why It Matters

The clarification expands the consumer wearable market while pressuring med‑tech firms to differentiate with clinical validation, reshaping competitive dynamics and patient‑care pathways.

Key Takeaways

• FDA clarifies wellness vs medical device boundary
• Wearables avoid regulation if no medical claims
• Med‑tech firms must emphasize clinical validation
• Companies adopt tiered wellness‑medical product portfolios
• Clinicians remain skeptical of unvalidated consumer data

Pulse Analysis

The FDA’s latest guidance on low‑risk wearables does not rewrite the rulebook; it simply re‑emphasizes the intended‑use test that separates general‑wellness gadgets from regulated medical devices. By stating that any claim to diagnose, treat, or manage disease triggers full FDA oversight, the agency gives consumer‑technology firms a clearer path to launch sensor‑rich products that stop short of medical assertions. This clarification reduces regulatory ambiguity, encouraging more companies to introduce health‑adjacent wearables that monitor heart rate, oxygen saturation, or glucose without seeking clearance, thereby expanding the wellness segment. Med‑tech manufacturers now face a dual‑front battle: retain clinical credibility while competing with cheaper, aesthetically appealing wellness devices. To stand out, firms must lean on proven accuracy across diverse patient groups, robust performance under motion or low‑perfusion conditions, and seamless integration into electronic health records. Companies such as Abbott, Dexcom and Medtronic illustrate a tiered approach, offering over‑the‑counter wellness sensors alongside fully regulated continuous glucose monitors and insulin‑pump systems. This portfolio segmentation creates early‑stage consumer engagement, builds brand trust, and provides a migration path from lifestyle monitoring to reimbursable medical therapy. Clinicians remain cautious because wellness wearables rarely meet clinical validation standards, forcing providers to duplicate measurements with FDA‑cleared devices before making treatment decisions. This limits the immediate utility of consumer data but does not eliminate its conversational value; trends can prompt further testing or lifestyle counseling. As the market blurs, clear labeling of intended use becomes essential to protect patients and preserve trust. Over time, successful integration will depend on hybrid models that combine the convenience of consumer sensors with rigorous back‑end analytics, creating a bridge between everyday health awareness and actionable medical insight.

FDA’s new guidance on consumer wearables makes the medtech market more complex

By Bill Betten, S3 Connected Health

Abbott’s Lingo is an over‑the‑counter wearable biosensor for continuous glucose monitoring (CGM). Abbott is just one medical device developer that is expanding its portfolios across the wellness–medical continuum.

The FDA’s recent guidance on wearables has been widely described as a major shift, but the changes are really more incremental.

What the FDA has done is clarify (rather than redraw) the boundary between general‑wellness products and regulated medical devices. Devices intended to diagnose, treat, cure, or manage disease remain fully regulated. Devices positioned purely for general wellness—such as those that track fitness, recovery, and lifestyle habits—continue to fall largely outside formal FDA oversight.

The decisive factor remains intended use and claims. A wearable can measure physiological signals like heart rate, oxygen saturation, or even glucose, but it becomes a medical device the moment it claims to guide medical decisions. That distinction is not new, and the FDA’s guidance reinforces it rather than relaxing it.

Consumer wearables are becoming more sophisticated, but clinicians are still wary of using them to diagnose, treat, or manage conditions.

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By explicitly allowing more sensor‑based wearables to qualify as general‑wellness products, the FDA has reduced regulatory ambiguity for consumer‑technology companies. This gives manufacturers greater confidence to launch devices that monitor increasingly sophisticated physiological data—provided they stop short of medical claims.

The result will almost certainly be more consumer wearables that look, feel, and sound medical without being regulated as such. Wearables will continue to push upward, offering richer data and health‑adjacent insights framed around trends, awareness, or lifestyle optimization.

However, this creates a tension around value. If a device cannot claim medical accuracy or clinical utility, what are consumers actually paying for? For many users, the answer may be convenience, design, brand, or perceived insight rather than proven clinical benefit.

For clinicians, the situation is more complicated. In theory, data from consumer wearables could provide useful context or early signals. In practice, most clinicians remain cautious. Wellness devices are typically not validated to medical standards, not tested across complex patient populations, and not designed for use in challenging real‑world clinical conditions.

If a patient arrives with data from a consumer wearable, clinicians frequently must repeat the measurement using a regulated medical device before acting on it. That limits the practical utility of wellness data in clinical workflows.

Accuracy and reliability are also concerns. Consumer devices often perform well on healthy users under ideal conditions, but struggle with motion, low perfusion, tremors, poor circulation, or incorrect placement—precisely the scenarios common in older or sicker patients.

As a result, most clinicians see wellness wearables as informational at best: something that may prompt a conversation or further testing, but rarely as a basis for diagnosis or treatment.

What does this mean for medical device companies?

For medical device companies, the FDA guidance does not reduce regulatory burden, but it does increase competitive pressure.

Regulated devices must now compete in a market crowded with cheaper, consumer‑grade alternatives that appear similar on the surface. This makes differentiation harder and puts pressure on pricing, positioning, and value propositions.

To stand out, medical device companies must emphasize what consumer wearables cannot easily replicate: proven accuracy across diverse and high‑risk populations; performance under non‑ideal conditions; clinical validation and regulatory approval; and integration into clinical workflows and decision‑making.

At the same time, many established med‑tech companies are responding by expanding their portfolios across the wellness–medical continuum, rather than remaining anchored at the fully regulated end of the spectrum. Abbott provides a clear example, with a glucose‑monitoring portfolio that now includes:

• Lingo – positioned as a wellness glucose monitor

• Libre Rio – targeted at people with Type 2 diabetes

• FreeStyle Libre – a fully medical‑grade continuous glucose monitor (CGM) used in clinical care

Rather than treating wellness and medical markets as mutually exclusive, they have embraced a segmented approach, offering solutions at multiple levels of regulatory oversight and clinical involvement. This allows them to engage consumers earlier, build familiarity and trust outside traditional clinical settings, and create on‑ramps that may later lead to more formal medical care.

Importantly, this strategy is not about diluting medical rigor. Abbott continues to invest heavily in regulated devices, clinical evidence, and provider relationships. The expansion into wellness reflects a recognition that health engagement increasingly begins outside the healthcare system, and that ignoring that reality risks ceding ground to consumer‑technology companies.

Dexcom and Medtronic are pursuing similar trajectories. Both have historically operated squarely within regulated, clinician‑driven markets, but are now experimenting with ways to reach broader populations, simplify access, and lower friction—whether through over‑the‑counter pathways, consumer‑friendly design, or partnerships that blur the line between clinical and lifestyle use.

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In summary

Ultimately, the FDA’s guidance makes the market more complex rather than making life easier for medical device companies. Success will depend not just on engineering or regulatory expertise, but on strategic clarity: knowing which problems are best solved with wellness tools, which require medical‑grade solutions, and how to connect the two without undermining trust.

The risk, of course, is confusion. When a company offers both wellness and medical solutions, it must be exceptionally clear about intended use, limitations, and appropriate contexts. Regulators, clinicians, and patients alike will scrutinize whether these distinctions are maintained in practice, not just in labeling. It is challenging for a consumer to wade through this morass of information.

A useful parallel can be drawn with the pharmaceutical industry. Drugs are designed to treat, prevent, or cure diseases and are regulated by the FDA. Supplements are intended to supplement the diet and support overall health, not treat specific ailments, and therefore are treated basically as food and are not regulated in the same fashion as drugs.

Perhaps consumer wearables are the supplements of the medical‑device world. In that case, the term “caveat emptor” (“let the buyer beware”) is particularly relevant, meaning the buyer alone is responsible for checking the quality and suitability of goods before a purchase.

Bill Betten is director of solutions — medtech at S3 Connected Health, where he utilizes his decades of experience in the medical and life‑science industry to advance medical‑device and product development, with an emphasis on connected devices and digital health. Betten previously served in development and executive‑management roles at several medical‑device and Fortune 500 companies.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of Medical Design & Outsourcing or its employees.