On January 6, 2026, FDA issued a revised version of its General Wellness Policy for Low Risk Devices (“Revised General Wellness Policy”). Although the Revised General Wellness Policy may advance innovation for some wearable and sensor-enabled wellness products, it introduces new questions and a few ambiguities that may be challenging to implement in practice.
We outline the key takeaways below.
Software functions intended solely for maintaining or encouraging a healthy lifestyle and are unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition are excluded from the definition of a medical device under Section 520(o)(1)(B) of the Federal Food, Drug, and Cosmetic Act (FDCA). Non-software products intended solely for such uses are subject to enforcement discretion, meaning FDA does not intend to enforce requirements under the FDCA.
Additionally, software and non-software products intended to reduce the risk of or help users live well with certain chronic diseases or conditions through healthy lifestyle choices also are subject to enforcement discretion.
FDA issued final guidance on general wellness products most recently in 2019, and the Revised General Wellness Policy supersedes that guidance.
1. Focus on Wearables
All the revisions focus specifically on sensor-based technologies (particularly wearables) that measure physiologic parameters such as blood pressure, blood glucose, blood oxygen saturation, and heart rate variability. This emphasis aligns with broader federal attention to consumer wearables, including the HHS Secretary’s recent announcement of a campaign to encourage their use for tracking health metrics, as well as FDA’s publication of a list of authorized medical devices incorporating sensor-based technologies.
The prior version of the general wellness policy left open questions regarding which physiologic parameters measured and reported by wearables could fall within the general wellness category and which FDA viewed as inherently clinical. Moreover, as consumer wearables increasingly measured parameters traditionally measured by medical devices, FDA’s product-specific actions added to that uncertainty. For example, FDA announced that blood oxygen saturation products could be wellness, but at the same time required continuous glucose monitors for wellness uses and blood pressure monitors to obtain 510(k) clearances as devices. The Revised General Wellness Policy provides clarity on this landscape and, with respect to one physiologic parameter, reflects a notable change in the Agency’s approach (below).
2. A Notable Course Correction on Blood Pressure, And New Clarity for Other Parameters.
One of the most important updates in the Revised General Wellness Policy is FDA’s discussion of sensor-based wearables that estimate or output blood pressure.
In mid-2025, FDA took a high-profile stance through a warning letter and subsequent Safety Communication that products intended to measure or estimate blood pressure are regulated medical devices and not general wellness products, given blood pressure’s inherent association with clinical conditions like hypertension.
The Revised General Wellness Policy departs from that position. FDA now explains that non-invasive products that estimate or output a variety of physiologic parameters, including blood pressure, for wellness uses can qualify as general wellness products if their intended use is strictly wellness-focused and they meet other conditions in the guidance. Examples include:
- A product that outputs blood pressure alongside sleep metrics and pulse rate, without referencing a disease or condition.
- A wearable that estimates blood glucose for monitoring nutritional impacts, if specifically contraindicated for use with diabetics and pre-diabetics.
That said, FDA draws a clear line at invasiveness – even for minimally invasive products. The Revised General Wellness Policy indicates that a blood glucose wearable that uses “minimally invasive microneedle technology” is not “low risk,” even if its claims are purely wellness oriented (consistent with FDA’s clearance of CGMs for wellness uses).
This evolution in FDA’s thinking raises an important practical question for developers: Are there any biomarkers inherently associated with clinical conditions such that products measuring or outputting them can never fall within the general wellness category? Or do these revisions signal that FDA is now focused on the claims and intended use of the measurement, rather than what parameter is being measured?
3. Opening the Door, Not Removing the Gate.
The Revised General Wellness Policy imposes several guardrails, including that the sensor-based wearables described above cannot remain in the general wellness bucket if they:
- Include values that “mimic those used clinically,” if such values are not validated;
- Claim to be a substitute for an FDA-cleared device, including claims of clinical equivalence, clinical accuracy, or medical grade;
- Prompt or guide specific clinical action or medical management, including through alerts or alarms;
- Include treatment guidance intended to inform or direct medical management;
- Measure, estimate, or report physiologic values for medical purposes such as screening, diagnosis, monitoring, alerting or management of a disease or condition; or
- Include references to specific diseases, clinical conditions, or diagnostic thresholds.
These limitations reinforce that FDA may still be carefully policing the line between wearables intended solely for general wellness purposes and those potentially intended for clinical use or to inform clinical decision making.
However, some of these limitations may create practical challenges for developers. For example, the Revised General Wellness Policy permits wearables to include values that “mimic those used clinically,” but only if such values are validated. But, FDA also states that claims of clinical accuracy or equivalence are inappropriate. This tension creates a challenge for companies seeking to communicate to prospective users that their products are sufficiently validated without crossing into restricted clinical performance claims.
4. A Carefully Drawn Opening for User Notifications.
One of the more nuanced additions in the Revised General Wellness Policy is FDA’s acknowledgement that sensor-based wellness products may include “a notification informing a user that evaluation by a healthcare professional may be helpful when outputs fall outside ranges appropriate for general wellness use.”
However, FDA tightly cabins this flexibility. Such notifications must:
- Avoid naming diseases or conditions;
- Avoid characterizing outputs as abnormal, pathological, or diagnostic;
- Exclude clinical thresholds, diagnoses, or treatment recommendations; and
- Avoid ongoing alerts or monitoring intended to manage a disease.
This raises meaningful questions about what such a notification would look like under these parameters. For example, how would a product flag for a user that an output is outside wellness ranges without implying abnormality or referencing clinical thresholds? How should “ranges appropriate for general wellness use” be defined?
5. What This Means (Or Doesn’t Mean) for AI.
Despite FDA’s framing of these revisions as a new guidance on AI, the Revised General Wellness Policy notably does not directly address AI. As noted, the substantive edits are focused specifically on sensor-based wearables, not AI-enabled analytics or health and wellness chatbots.
The revisions may, however, indirectly support arguments that AI tools leveraging data from wellness wearables can also fall outside of medical device regulation as general wellness tools, if the other conditions in the guidance are met. For example, while minimally invasive CGM sensors are not general wellness products under the Revised General Wellness Policy, the CGM example in the guidance suggests that AI that uses data from a CGM to provide nutritional guidance could be wellness. Questions remain on whether FDA intends to more squarely address AI in future guidance, such as in planned revisions to the Agency’s Policy for Device Software Functions and Mobile Medical Applications in FY26.
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Of note, FDA issued the Revised General Wellness Policy as a revised final guidance with no formal comment period. Although stakeholders may comment on guidance at any time, as a practical matter, FDA may not act upon such comments until the document is next revised or updated. Our team is closely tracking these developments and would welcome the opportunity to discuss strategic, constructive ways to engage with FDA on the revisions and the open questions they raise.
If you have any questions concerning the material discussed in this client alert, please contact the following members of our Digital Health practice.
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