In this article we will take a look at what is new in the 2026 version of the FDA guidance document, “General Wellness: Policy for Low Risk Devices.”

Recent history of FDA’s regulation of general wellness products:

• In 2016. section 3060(a) of the Cures Act amended section 520 of the FD&C Act to remove certain software functions from the device definition, including those intended for maintaining or encouraging a healthy lifestyle that are unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition.
• The CDRH released the General Wellness: Policy for Low Risk Devices guidance in 2016, explaining that CDRH did not intend to examine low risk products that promote a healthy lifestyle (general wellness products) to determine whether they are devices within the meaning of the FD&C Act.
• In January of 2026, FDA issued an updated version of the General Wellness: Policy for Low Risk Devices guidance.

What is a general wellness product?

The definition of a general wellness product remains unchanged from the 2016 to the 2026 version of the guidance document. CDRH defines a general wellness product as products that 1) are intended for only general wellness use, and 2) present a low risk to the safety of users and other persons. Furthermore, a general wellness product has 1) an intended use that relates to maintaining or encouraging a general state of health or a healthy activity, or 2) an intended use that relates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition.

Both versions of the guidance divide general wellness products into two categories:

1. Intended uses relate to claims about sustaining or offering general improvement to functions associated with a general state of health that do not make any reference to diseases or conditions. (weight management, physical fitness, relaxation/stress management, mental acuity, self-esteem, sleep management, sexual function)
2. Intended uses relate to sustaining or offering general improvement to functions associated with a general state of health while making reference to diseases or conditions. The intended use may promote/track and/or encourage choice, which, as part of a healthy lifestyle, either “may help to reduce the risk of” or “may help living well with” certain chronic diseases or conditions.

The 2026 wellness guidance added much more detail after the examples of disease-related general wellness claims in the second category. One big change is that FDA advises that they may now consider certain products that use non-invasive sensing (e.g. optical sensing) to 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 not-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 guide 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.

Products that meet the aforementioned criteria may display values, ranges, trends, baselines, or longitudinal summaries, and may contextualize these outputs in relation to sleep, activity, stress, recovery, or similar wellness domains. The guidance advises that the labeling, advertising, user interface, or functionality should be very circumspect. Any notifications generated by the product should not reference a specific disease or medical condition, should not characterize the output as abnormal/pathological/diagnostic, should not include treatment recommendations, and should not provide ongoing alerts or monitoring intended to manage a disease or condition.

What are examples of general wellness products?

The guidance is full of examples of what may be a general wellness product: exercise equipment, audio recordings, video games, software programs, etc. The “software programs” example has the additional guidance suggested by the FDA in Policy for Device Software Functions and Mobile Medical Applications. In section V, “Examples of General Wellness Products that Are Not Medical Devices and Examples of General Wellness Products that Are Medical Devices for which FDA Does Not Intend to Enforce Requirements,” the 2026 guidance added three new illustrative examples:

1. A wrist-worn wearable product intended to assess activity and recovery that outputs multiple biomarkers, among which are hours slept, sleep quality, pulse rate, and blood pressure. Sleep is measured via an accelerometer, while pulse rate and blood pressure are measured via a photoplethysmogram.
   *Qualifiers: the claim relates to general wellness and does not refer to a specific disease or medical condition, is low risk, and the product has validated values for blood pressure
2. A wearable product that is intended to provide estimations of blood glucose for monitoring nutritional impacts. The blood glucose measurement is made via minimally invasive microneedle technology, is explicitly contraindicated for use with diabetics and pre-diabetics, and is marketed to users as a means of better understanding their insulin response to certain foods.
   *Here, the claim relates to a general understanding of a user’s health (general wellness claim) but the product penetrates the stratum corneum and is therefore not a low risk general wellness product.
3. A non-invasive wearable product advertised toward elite athletes and intended for monitoring of several parameters, among which are electrolyte balance, lactate, and hemoglobin. The product is labeled as for use in an exercise/fitness context only, displays values from cleared devices or ranges from the wearable’s optical sensor, and is disclaimed for use diagnosing any condition or disorder.
   *Here, it is a general wellness claim and is low risk, therefore is a low risk general wellness product

Is your product impacted by the wellness guidance or mobile medical app guidance? Find other SoftwareCPR news items on the regulation of mobile medical apps here.