The digital health landscape is undergoing a seismic shift—and January 2026 marked a major milestone. The U.S. Food and Drug Administration (FDA) released two transformative guidance documents, one focused on Clinical Decision Support (CDS) software and the other on General Wellness Products. These new policies redraw the regulatory lines for what qualifies as a “medical device,” and where the FDA is willing to exercise its enforcement discretion, opening a wide lane for health tech developers building in the CDS, wellness, longevity, and wearable tech space.
This two-part series breaks down the 2026 updates and what they mean for your business. Whether you're designing clinical software or consumer wellness tools, the implications are huge. The updated guidance doesn't just tweak definitions—it significantly expands the boundaries for innovation, allowing some technologies previously considered “devices” to now fall outside FDA oversight entirely.
Part One, which you're reading now, focuses on General Wellness Products and the opportunities created by this new guidance. The FDA has clarified and, crucially, loosened restrictions around non-invasive physiological tracking, labeling practices, and low-risk devices. For companies developing health wearables, lifestyle apps, or longevity tech, this is the green light you've been waiting for.
Part Two will dive into the updated guidance for Clinical Decision Support tools. These revisions matter deeply for software developers aiming to build AI-driven diagnostics, triage tools, or clinician-facing analytics engines without triggering burdensome regulatory requirements.
From the resurgence of preventative wellness to the rise of bio-tracking in consumer devices, the FDA’s new 2026 policy isn’t just a compliance update—it’s a blueprint for innovation. If you’re a startup founder, product manager, or regulatory strategist in the health tech space, now is the time to act.
Let’s unpack how the new General Wellness guidance reshapes the opportunity landscape in 2026 and beyond.
General Wellness Products: The FDA Loophole Powering Consumer Healthtech
Understanding the regulatory landscape for general wellness products requires knowing its origin story. In 2016, Congress passed the 21st Century Cures Act, which carved out specific software functions from the definition of “medical device”-effectively exempting software functions intended “for maintaining or encouraging a healthy lifestyle and is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition” from FDA oversight. The FDA refers to these as “general wellness products.” Separately, the FDA exercises enforcement discretion for low-risk general wellness products that technically meet the definition of a device but pose minimal safety concerns. This dual framework-statutory exemption plus agency discretion-created a safe harbor for companies to innovate in the wellness space without navigating the costly, time-intensive FDA compliance process. The 2026 guidance update significantly expands this safe harbor, making it critical to understand what qualifies for exemption and what crosses the line into regulated territory.
The 2019 policy was FDA’s first attempt at clarifying the agency’s interpretation of this provision of the Cures Act. This document and the most recently published 2026 guidance aren’t law per se, but serve to provide insight into how the agency might think through an analysis of a particular software function to determine whether it is exempt from FDA clearance. The 2026 update modernizes FDA policy in several ways:
- Expanded safe harbor for physiologic parameter monitoring: Products using non-invasive sensing (e.g., optical sensing) to estimate or output physiologic parameters like blood pressure, oxygen saturation (SpO2), blood glucose, and heart rate variability may now qualify as general wellness products, provided they meet specific criteria and don't substitute for FDA-authorized devices or guide clinical action.
- Clarification on displaying values and contextualization: Products can now display values, ranges, trends, baselines, or longitudinal summaries and contextualize these outputs in relation to wellness domains like sleep, activity, stress, and recovery while still qualifying as general wellness products.
- SpO2 monitoring explicitly included: The guidance now explicitly recognizes monitoring oxygen saturation (SpO2) during exercise as low-risk technology that doesn't require regulatory controls when used for general wellness purposes.
- Enhanced validation pathways: Companies can validate clinically mimicking values through manufacturer testing, clinical studies, or peer-reviewed clinical literature to maintain general wellness product status.
- Refined boundaries on notifications: Clear exception allowing products to notify users that healthcare professional evaluation may be helpful when outputs fall outside ranges, provided specific conditions are met (no disease identification, no diagnostic characterization, no clinical thresholds).
It's important to note that the guidance doesn't contain explicit analysis for every use case, intended use, or product function-the FDA can't anticipate every innovation. However, the guidance is a framework for analysis, especially when supplemented with consideration of evolving federal policy trends. For thoughts on this, be sure to follow me on LinkedIn. Things are moving fast.
How do I know if my product qualifies as a General Wellness Product?
FDA’s policy on general wellness products has always rested on two pillars:
- The product must be intended solely for general wellness use. That is, it promotes or encourages maintaining a "healthy lifestyle," and it is not intended to diagnose, cure, mitigate, prevent, or treat a specific disease or condition.
- The product must be low-risk to its users and others.
So, what does that mean, specifically?
The FDA recognizes two primary categories of “general wellness use" (with important 2026 expansions discussed below):
Category 1: General Health Improvement (No Disease References)
You may not make any reference to diseases or conditions—this category is for making general improvements to health.
Permissible claims may relate to:
- weight management,
- physical fitness, including products intended for recreational use,
- relaxation or stress management,
- mental acuity,
- self-esteem,
- sleep management, or
- sexual function.
Examples of Category 1 products include fitness trackers, mindfulness apps, and dietary logging tools, provided they avoid disease-specific claims.
Category 2: Healthy Lifestyle with Disease References (Limited Scope)
You may reference specific diseases or conditions, but only in the context of maintaining or generally improving functions associated with overall health. If you make a Category 2 claim, you should be able to point to peer-reviewed scientific studies, statements, or other publications that support this claim.
Category 2 has two subcategories:
- intended uses to promote, track, and/or encourage choice(s), which, as part of a healthy lifestyle, may help to reduce the risk of certain chronic diseases or conditions; and
- intended uses to promote, track, and/or encourage choice(s) which, as part of a healthy lifestyle, may help living well with certain chronic diseases or conditions.
If you claim that the use might help restore a structure or function impaired by a disease, you will fall outside of this exemption.
Plain Language Example: An app that tracks daily walking and encourages users to "maintain mobility and joint flexibility as part of a healthy lifestyle for those living with arthritis" would likely qualify as a Category 2 general wellness product. However, if the same app claimed to "restore joint function impaired by arthritis" or "improve range of motion lost due to arthritis," it would fall outside the general wellness exemption because it's claiming to restore a function that was impaired by disease, making it a regulated medical device.
2026 EXPANSION OF GENERAL WELLNESS CRITERIA: Physiologic Parameter Monitoring Via Non-Invasive Sensing
In the 2026 guidance, the FDA included new language confirming that they 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, and provided they:
- are non invasive-and non-implanted;
- do not involve an intervention or technology that may pose a risk to the safety of users or other persons if specific regulatory controls are not applied;
- are not intended for the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition;
- are not intended to substitute for an FDA-authorized, cleared, or approved device;
- do not include claims, functionality, or outputs that prompt or guiide specific clinical action or medical management; and
- do not include values that mimic those used clinically unless validated (e.g. manufacturer testing, peer-reviewed clinical literature) to reflect those values.
The majority of these new criteria are related to how a product is marketed—that is, the claims you make about the product's intended use. This provides companies with significant flexibility to offer wellness products outside FDA clearance that could otherwise be considered medical devices if marketed differently. For example, a smartwatch that uses optical sensing to capture blood pressure and pulse rate would not qualify for the general wellness exemption if it claims to help detect hypertension, but would likely qualify if it claims to help assess activity levels and recovery.
Three criteria from the 2026 expansion warrant additional explanation:
Claims, functionality, or outputs that prompt or guide specific clinical action or medical management
The 2026 guidance creates an important exception for companies that provide consumer notifications. Products may notify users that evaluation by a healthcare professional may be helpful when outputs fall outside ranges, provided the notification:
- Does not identify or name a specific disease or medical condition;
- Does not characterize the output as abnormal, pathological, or diagnostic;
- Does not include clinical thresholds, diagnoses, or treatment recommendations; and
- Does not provide ongoing alerts or monitoring intended to manage a disease or condition.
Values that mimic those used clinically unless validated
Companies may validate clinically-mimicking values through manufacturer testing, clinical studies, peer-reviewed clinical literature, or similar methods.
Intervention or technology that may pose a risk to the safety of users or other persons if specific regulatory controls are not applied
How do you determine the risk level? The "low risk" analysis framework discussed later in this document provides guidance.
What Products Can Display and Still Qualify
The 2026 guidance clarifies that products can display values, ranges, trends, baselines, or longitudinal summaries, and may contextualize these outputs in relation to sleep, activity, stress, recovery, or similar wellness domains while still qualifying as general wellness products.
Examples of (likely) permissible displays include:
- A fitness wearable that displays heart rate variability (HRV) trends over time with contextualization like "Your HRV suggests you may benefit from additional recovery time before your next workout"
- A wellness app that shows blood glucose estimates with statements like "Your glucose levels appear elevated after meals high in refined carbohydrates-consider whole grain alternatives to support sustained energy."
- A smartwatch that displays estimated blood pressure readings alongside activity data with messaging such as "Your blood pressure readings tend to be lower on days when you complete 30+ minutes of aerobic exercise."
- A sleep tracker that reports SpO2 levels during sleep with context like "Your oxygen saturation remained stable throughout the night, supporting restorative sleep."
However, products do NOT qualify as general wellness products if they measure, estimate, or report physiologic values for medical or clinical purposes, including screening, diagnosis, monitoring, alerting, or management of a disease or condition. Regulated devices include: blood pressure monitors or sphygmomanometers, blood glucose measuring devices (such as fingerstick meters and continuous glucose monitoring systems), electrocardiogram recording and analysis devices, and any product intended to provide outputs used to make treatment decisions (e.g., medication dosing).
Examples that would require FDA authorization:
- A device that measures blood pressure and alerts users when readings exceed clinical thresholds for hypertension (e.g., "Your blood pressure is 140/90 - this may indicate hypertension, consult your doctor")
- An app that provides blood glucose readings with insulin dosing recommendatioons
- A wearable that provides blood glucose readings with insulin dosing recommendations
- A wearable that analyzes ECG data and identifies arrhythmias or alerts users to potential atrial fibrillation
- Any device marketed to screen for, diagnose, or manage specific diseases or conditions
IMPORTANT DISTINCTION: Many consumer wearables display values from FDA-cleared device components. Simply incorporating or displaying values from an FDA-cleared device does not disqualify your product from being a general wellness product; the intended use and marketing claims remain the determining factors.
Companies Pushing the Envelope
That said, many companies are bumping up against regulatory boundaries. In July 2025, the FDA warned Whoop, a consumer wellness device company, that its blood pressure insights (BPI) made its product a regulated device under the FD&C Act. The FDA states in the warning letter that because the company markets BPI as a tool to measure its users’ blood pressure, a measurement the agency believes is inherently associated with the diagnosis of hypotension and hypertension, BPI does not qualify as a general wellness product. Whoop, as stated in the article, “indicated its intention to continue marketing BPI without appropriate FDA authorization despite FDA's repeated assertions that BPI is a medical device and therefore requires FDA authorization to be legally marketed.” Buckle up, folks. They aren't the only player in the space testing how far they can push to win the consumer healthcare innovation race.
Low-Risk Requirement: What Does "Low Risk" Mean?
1. Exclusionary Factors: A product is NOT low risk (and therefore not covered by this guidance) if the answer to any of the following is YES:
- Does it penetrate or pierce the skin or mucous membranes?
- Is it implanted?
- Does it involve an intervention or technology that may pose safety risks without regulatory controls (e.g., lasers, electrical stimulation, radiation exposure)?*
*For this analysis, it can be helpful to determine whether FDA actively regulate products of the same type and the types of controls they require to determine that such product is "safe".
2. What constitutes "sufficient risk" to trigger FDA regulation? The FDA doesn't provide a bright-line test in this guidance, and leaves this largely open to interpretation. The agency does, however, provide examples demonstrating how it would analyze some specific use cases. These examples show that certain technologies are considered low-risk for general wellness purposes when marketed without disease-specific claims:
- Exercise activity monitoring (for cardiovascular health improvement): While inaccuracy presents some risk, the technology is considered low-risk when marketed without disease or medical condition claims.
- Food consumption tracking (for weight management): Considered low-risk technology.
- Pulse rate and oxygen saturation (SpO2) monitoring during exercise: Considered low-risk technology. (Note: SpO2 reference is new in 2026!)
- Sleep, pulse rate, and blood pressure monitoring (for general wellness purposes): Considered low-risk technology. (Note: This example is new in 2026!)
- Electrolyte balance, lactate, and hemoglobin measurement (for exercise and fitness): Considered low-risk technology, provided the values are validated (Note: This example is new in 2026!)
The FDA also applies the International Organization for Standardization (ISO) 14971 framework when evaluating medical device risk, making this a valuable resource for companies assessing their own products. While the FDA has no statutory or regulatory definition of "risk," the agency evaluates two key factors: (1) probability of harm and (2) severity of harm. This analysis considers both scenarios where the device functions as intended and where it fails. Companies should consult a regulatory professional for a comprehensive risk assessment, but a practical starting point is to document all potential hazards and analyze their associated risk levels.
What's Next?
The 2026 General Wellness guidance signals where the FDA is headed: toward greater flexibility, lighter regulatory touch, and an agency willing to get out of the way of innovation. By clarifying and expanding the regulatory boundaries for wellness products—particularly in the realm of physiologic parameter monitoring—the FDA has opened significant opportunities for companies developing wearables, longevity tech, and consumer health tools. This shift aligns with broader federal priorities favoring innovation over intervention.
The high level takeaway? if your product promotes healthy lifestyles, uses non-invasive sensing, avoids disease-specific diagnostic claims, and poses minimal safety risk, you may be able to bring it to market without FDA clearance.
But wellness products are only half the story. The second major regulatory shift in 2026 involves Clinical Decision Support (CDS) software—tools designed to assist healthcare providers in clinical decision-making. If you're building AI-driven diagnostics, clinical analytics platforms, triage tools, or provider-facing software, the updated CDS guidance fundamentally reshapes what triggers FDA regulation and where the agency will exercise enforcement discretion.
Part Two of this series, coming soon, will break down the 2026 CDS guidance and explore:
- What qualifies as CDS software that is exempt from FDA oversight
- The four critical factors the FDA uses to determine if CDS requires regulatory clearance
- How AI and machine learning tools fit into the new framework
- Practical strategies for building provider-facing clinical tools that stay outside FDA jurisdiction
The regulatory landscape continues to evolve, and understanding both the wellness and clinical tool frameworks is essential for any health tech company navigating 2026 and beyond. Stay tuned for Part Two.
-----
Need help determining if your product qualifies? I've created an FDA General Wellness Product Determination Guide designed to streamline your analysis of specific product functions and features. This practical resource walks you through the key decision points outlined in the 2026 guidance and helps you quickly assess whether your product meets the general wellness exemption criteria. If you'd like a copy, email me at rebecca@elevarelaw.com, and I'll send it your way.