FDA’s 2026 General Wellness Policy and What It Means for Manufacturers of Wearable Devices

Wearable devices are products worn on the body that use sensors and software to collect and display health or lifestyle information such as activity, sleep, or recovery trends.

Why FDA updated the policy

Wearable technology has advanced quickly. Many products now estimate physiological measures typically associated with clinical care, (e.g., blood pressure, oxygen saturation, blood glucose, heart rate variability). FDA has emphasized that regulatory status can shift based on intended use, as reflected in product claims, marketing, and how information is presented to users.

That concern became more visible in July 2025, when FDA issued a Warning Letter to WHOOP, Inc. FDA alleged that WHOOP marketed its “Blood Pressure Insights” feature without required clearance or approval, citing statements describing daily blood pressure estimations and “medical grade” insights. The letter illustrates how wellness positioning can shift into medical device territory based on claims and presentation, even where a product is otherwise framed as consumer focused.

What the general wellness policy does

FDA’s General Wellness: Policy for Low Risk Devices, finalized January 6, 2026, describes how FDA approaches low risk products marketed for general wellness purposes. The guidance explains that FDA uses enforcement discretion for products that are limited to general wellness use and present low risk to users and others.

FDA evaluates the following two key factors in determining whether a product qualifies as a general wellness product:

The product’s intended use is limited to general wellness, and
The product presents low risk to the safety of users and other people.

When those conditions are met, FDA indicates that it does not expect the product to go through the typical medical device regulatory process for requirements (e.g., registration and listing, labeling, quality system requirements, medical device reporting).

How FDA evaluates wearable products

Against that policy framework, FDA’s 2026 update clarifies how these concepts are applied in practice to wearable products that estimate physiological measures.

Intended use

FDA evaluates whether a product qualifies as a general wellness product by first examining intended use, which FDA infers from claims, labeling, advertising, and how features and information are presented to users. In practice, intended use is shaped not only by what a product says, but by how a user is expected to rely on it.

Under the guidance, general wellness use typically falls into one of the following categories:

General wellness only: Claims that promote or support a general state of health or a healthy activity (e.g., fitness, stress, sleep, weight management) without referencing a disease or condition.
Lifestyle-linked disease risk: Claims that link healthy lifestyle choices to reducing disease risk or helping users live well with a chronic condition, where that link is well established.

For wearable features that estimate physiological measures, intended use remains within general wellness when the product:

Avoids diagnosis or treatment claims, including references to curing, mitigating, preventing, or treating disease.
Does not substitute for medical devices or clinical care, either expressly or by implication.
Does not prompt users to take specific clinical or medical actions, such as adjusting treatment or managing a condition.

Because FDA considers the overall impression created by these elements, even small changes in language, displays, or prompts can affect how intended use is interpreted.

Low risk to users

FDA’s wellness policy is meant for products that do not raise safety concerns for users.

For wearables, FDA typically looks for signs of low risk such as:

Measurements are taken without breaking the skin or using implants.
The design does not raise safety risks that would normally require device-level safeguards.
Users are not encouraged to rely on the product for medical decisions.

Practical steps for wellness manufacturers

Because intended use and low risk can be shaped by how products are described, displayed, and updated over time, pre-launch and pre-update review should be built into development cycles.

Before launching a product or making major updates, manufacturers should consider the following steps to stay aligned with FDA’s general wellness policy:

Define and document the product’s wellness purpose. Clearly document that the product supports general wellness, not diagnosis or treatment, and make sure that purpose is reflected consistently across features, claims, screens, and user prompts.
Review all user-facing content as one package. Review marketing materials, in-app text, dashboards, notifications, and support content together to ensure they do not reference diseases, sound diagnostic, encourage medical decisions, or describe the product as “medical grade.”
Confirm low-risk design and appropriate data support. Make sure the product uses low-risk, non-invasive technology, does not encourage clinical reliance, and, where physiological values resemble those used in healthcare, that there is appropriate support showing the values reflect what is being presented without implying clinical accuracy.
Recheck positioning before updates go live. Apply the same review before releasing new features, algorithms, or updates to confirm that changes do not alter the product’s intended use or low-risk status over time.

These steps are relevant because FDA draws conclusions from the full record, not just a single claim. Consistent documentation helps show that wellness positioning is intentional, applied consistently, and maintained as features change.

Bottom line

FDA’s 2026 update clarifies how wearable features can remain within the general wellness framework by focusing on intended use and low risk, particularly for physiological measures. Manufacturers should build a pre-launch and pre-update review into release workflows now so claims, prompts, and displays stay aligned as products evolve.