FDA General Wellness Policy for Wearable Devices (2026): What Qualifies as a Non-Regulated Wellness Product

The Biggest Change to FDA's Wellness Policy in a Decade

On January 6, 2026, the FDA updated its final guidance "General Wellness: Policy for Low Risk Devices," materially expanding the types of wearable features that may avoid medical device regulation. The update — announced by FDA Commissioner Marty Makary at CES 2026 and characterized as a way for FDA to "get out of the way as a regulator" — responds to the explosive growth of consumer health technology and the confusion caused by the agency's July 2025 warning letter to WHOOP over its "Blood Pressure Insights" feature.

HHS Secretary Robert F. Kennedy Jr. said the changes "[unlock] wearable devices for general wellness that have, for too long, been tied up in red tape."

The most significant expansion: the FDA now says that certain wearable devices that estimate or output physiologic parameters — including blood pressure, blood glucose, oxygen saturation, and heart rate variability — may qualify as general wellness products when their outputs are intended solely for wellness uses and meet specific criteria.

This guide explains the new policy, how to determine whether your product qualifies, and where the boundaries between wellness and regulated medical device remain.

Background: General Wellness Under the 21st Century Cures Act

Section 3060(a) of the 21st Century Cures Act (December 2016) amended Section 520 of the FD&C Act to remove certain software functions from the definition of "device." Specifically, software "intended for maintaining or encouraging a healthy lifestyle and is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition" is not a device under Section 201(h) of the FD&C Act.

The FDA's General Wellness guidance interprets this statutory exclusion and describes the agency's enforcement discretion policy for products that may technically meet the device definition but pose low risk and are intended only for general wellness.

The 2019 version of the guidance provided six illustrative examples but was silent on products that measure physiologic parameters like blood pressure or glucose — creating years of uncertainty for wearable manufacturers.

The Two-Part Test: Does Your Product Qualify?

To qualify as a general wellness product that is not regulated as a medical device, a product must satisfy both of these factors:

Factor 1: Intended for General Wellness Use Only

A product's intended use is determined by its labeling, advertising, marketing materials, website, app store descriptions, user interface, and any other communications. General wellness use falls into two categories:

Category A — Pure wellness claims (no disease references): Claims that promote or support a general state of health or a healthy activity without referencing a specific disease or condition. Examples include:

• Weight management and fitness tracking
• Sleep management and relaxation
• Stress management and mental acuity
• General physical fitness or endurance

Category B — Lifestyle-linked disease risk claims: Claims that link healthy lifestyle choices to reducing the risk of, or helping people live well with, a chronic condition — where that link is well-established and generally accepted (e.g., the relationship between regular exercise and reducing the risk of heart disease).

Factor 2: Low Risk to Users and Others

The product must present a low risk to the safety of users and other persons. For wearable devices, the FDA typically considers:

• Non-invasive: The product does not penetrate the skin in ways that raise safety concerns
• No implants: The product is not implanted in the body
• No harmful energy: No lasers, radiation, or other potentially harmful energy delivery
• No risk without controls: The product does not pose a non-trivial risk if specific regulatory controls are not applied

The 2026 Expansion: Physiologic Parameters Now Allowed

The headline change in the 2026 update is the FDA's explicit recognition that certain products using non-invasive sensing to estimate or output physiologic parameters may be general wellness products. The guidance states:

"FDA may consider certain products that use non-invasive sensing (e.g., optical sensing) to estimate, infer, or output physiologic parameters (e.g., blood pressure, oxygen saturation, blood glucose, heart rate variability) to be general wellness products when such outputs are intended solely for wellness uses."

But the Conditions Matter

This is not a blanket exemption. The FDA attached six critical conditions:

1. Non-invasive technology only: The product must use non-invasive or minimally invasive technology that does not raise safety concerns. The FDA considers microneedle penetration of the stratum corneum as potentially not meeting the "low risk" threshold.

2. No higher-risk interventions: The product must not involve higher-risk interventions or technologies.

3. No disease diagnosis or treatment claims: The product must not be intended for diagnosing, treating, curing, or preventing any disease or condition.

4. Not a substitute for an FDA-authorized device: The product must not be intended to replace a cleared or approved medical device.

5. No clinical action prompts: The product must not prompt users to take specific clinical or medical actions, such as adjusting medication, managing a condition, or seeking emergency care based on diagnostic thresholds.

6. No clinically mimicking values (unless validated): The product must not output values that mimic those used clinically unless those values are validated — for example, through manufacturer testing or peer-reviewed clinical literature — to accurately reflect the physiologic parameter.

FDA's New Illustrative Examples

The 2026 update adds three new examples that illustrate how the policy applies to wearables measuring physiologic parameters:

Example 7: Multi-Biomarker Wrist Wearable

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 noninvasive technology.

FDA's determination: This qualifies as a general wellness product because:

• It uses non-invasive technology
• It is intended for activity and recovery assessment (wellness)
• Blood pressure output is presented in a wellness context, not a diagnostic context
• No disease or treatment claims are made

Example 8: Blood Glucose Estimation Wearable

A wearable product intended to provide blood glucose estimations for monitoring nutritional impacts using a minimally invasive microneedle technology.

FDA's determination: This is a more nuanced case. If the product is:

• Not intended for diabetic or pre-diabetic populations
• Marketed solely for nutritional awareness in a healthy population
• Using non-invasive technology

Then it may qualify. However, the FDA notes that minimally invasive microneedle technology that penetrates the stratum corneum may not meet the "low risk" criterion — meaning the technology itself can disqualify a product even if the claims are wellness-only.

Example 9: Athletic Performance Wearable

A noninvasive wearable product intended for monitoring electrolyte imbalance, lactate, and hemoglobin. The product is advertised toward elite athletes and is labeled for use in an exercise/fitness context only, with a disclaimer against use for diagnosing any condition.

FDA's determination: Qualifies as general wellness because:

• Non-invasive technology
• Targeted at athletes for performance monitoring
• Explicit disclaimer against diagnostic use
• No disease or treatment claims

Where the Line Is Drawn: Wellness vs. Medical Device

Understanding the boundary is critical. The following table contrasts permissible wellness positioning with claims that trigger medical device regulation:

The Presentation Trap

The FDA evaluates the overall impression created by all product elements — not just the explicit claims. Even if your marketing copy avoids disease language, the following can push a product into regulated territory:

• Color-coded alerts using clinical thresholds (e.g., red/green zones based on clinical guidelines)
• Notifications that prompt medical action (e.g., "Your blood pressure is high — see your doctor")
• Contextual framing that implies medical utility (e.g., showing lab-reference ranges alongside measurements)
• Targeting disease populations in advertising or app store descriptions

The FDA does permit certain general safety nudges — for example, notifying users that "seeking evaluation by a healthcare professional may be helpful when outputs fall outside ranges appropriate for general wellness use." But these notifications must not include clinical thresholds, diagnoses, or treatment recommendations.

The WHOOP Warning Letter Context

The 2026 update directly responds to the confusion caused by the FDA's July 2025 warning letter to WHOOP over its "Blood Pressure Insights" feature. That letter raised concerns about blood pressure estimation features being marketed without adequate validation and in ways that implied clinical utility.

The 2026 guidance essentially establishes the framework under which such features can be offered without triggering device regulation — but with guardrails that require validation and careful positioning.

Impact on the Wearable Industry

The updated policy has significant commercial implications:

Winners

• Consumer wearable companies (Oura, WHOOP, Apple, Garmin, Samsung): Expanded ability to offer physiologic monitoring features without 510(k) clearance, provided claims are carefully managed
• Digital health startups: Lower regulatory barriers for wellness-focused products
• Sports and fitness companies: Can offer advanced biomarker monitoring for athletes without device classification

Considerations

• Companies targeting disease populations: Products for diabetics, hypertensives, or other disease groups still require full regulatory compliance
• Products using invasive sensing: Microneedles and other skin-penetrating technologies may not qualify for the wellness exemption regardless of claims
• Products with AI-driven insights: If AI algorithms interpret data in clinically meaningful ways, the product may cross into regulated territory even if individual data points are "wellness-only"

Practical Checklist for Manufacturers

If you are developing a wearable or digital health product and want it to qualify as a general wellness product:

• Audit all product claims: Review labeling, marketing, website, app store descriptions, press releases, and social media for any disease-related language
• Review UI/UX for clinical framing: Ensure no clinical threshold alerts, diagnostic color coding, or medical action prompts
• Validate physiologic measurements: If outputting blood pressure, glucose, SpO2, or other clinical parameters, ensure accuracy through manufacturer testing or peer-reviewed validation
• Confirm non-invasive technology: Verify the sensing technology meets the FDA's "low risk" standard
• Add appropriate disclaimers: Include clear statements that the product is not intended for diagnosis, treatment, or management of any medical condition
• Document your analysis: Maintain records showing how your product meets both factors of the general wellness test
• Train marketing and sales teams: Ensure anyone communicating about the product understands the boundary between wellness and medical claims
• Monitor for claim drift: Regularly review user communications, social media, and app content to ensure no unauthorized claims emerge

What This Does NOT Cover

The General Wellness policy does not address:

• Clinical Decision Support (CDS) software: Addressed in a separate, simultaneously updated FDA guidance
• Software as a Medical Device (SaMD): Products that make clinical decisions or provide diagnostic outputs remain regulated
• Products requiring 510(k) clearance: If your product makes medical claims, it still needs appropriate FDA authorization
• State-level requirements: Some states may have additional requirements for health-related products
• FTC advertising requirements: Even if FDA does not regulate your product as a device, the FTC has authority over health claims in advertising
• HIPAA and privacy: Wellness products that collect health data may still have privacy obligations

The TEMPO Pilot: A Complementary Initiative

In parallel with the General Wellness guidance update, the FDA announced the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot. TEMPO seeks to promote digital devices for managing chronic diseases under clinician supervision. Unlike the General Wellness policy (which exempts products from regulation), TEMPO creates a pathway for regulated digital health devices to demonstrate meaningful patient outcomes.

The TEMPO pilot focuses on four clinical areas:

1. Early cardio-kidney-metabolic conditions (hypertension, dyslipidemia, obesity)
2. Heart failure and arrhythmias
3. Diabetes and metabolic conditions
4. Respiratory conditions

This initiative represents a separate track for companies that want to make clinical claims but need a streamlined pathway.

Key Takeaways

• The FDA's January 2026 General Wellness update significantly expands the types of wearable features that can avoid medical device regulation, including blood pressure, glucose, and oxygen saturation estimation.
• Products must still meet both factors of the general wellness test: wellness-only intended use AND low risk.
• The FDA added three new illustrative examples showing how multi-biomarker wearables, glucose estimation devices, and athletic performance monitors can qualify as non-regulated wellness products.
• The boundary between wellness and medical device remains driven by intended use — claims, marketing, and UI/UX presentation all factor into the FDA's analysis.
• Manufacturers should audit all product communications, validate physiologic measurements, and document their general wellness analysis.

Sources: FDA Final Guidance "General Wellness: Policy for Low Risk Devices" (January 6, 2026); Foley & Lardner LLP analysis (January 2026); Troutman Pepper Locke analysis (2026); McGuireWoods analysis (January 2026); Loeb & Loeb analysis (January 2026); Hardian Health analysis (2026); Blank Rome analysis (January 2026); Berkley Life Sciences analysis (2026); FDA Warning Letter to WHOOP, Inc. (July 14, 2025); Latham & Watkins analysis (January 2026).