The FDA released a final guidance update to the General Wellness: Policy for Low Risk Devices today (January 6, 2026) in what could only be characterized as a sudden and momentous event. It is worth noting that this came without any warning or period of public comment, which may signal that other final guidances may be updated in the future without a public comment period.
One of the major changes to the General Wellness guidance explicitly called out 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) may be general wellness products, and not subject to FDA enforcement or regulation, provided that 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. Another major change was the callout that a product may be considered a general wellness product, even if it includes a notification informing a user that evaluation by a healthcare professional may be helpful when outputs fall outside ranges appropriate for general wellness use, provided that such notifications:
- do not identify or name a specific disease or medical condition;
- do not characterize the output as abnormal, pathological, or diagnostic;
- do not include clinical thresholds, diagnoses, or treatment recommendations; and
- do not provide ongoing alerts or monitoring intended to manage a disease or condition.
Today’s news is a huge win for Whoop, who publicly disagreed with the FDA’s assertion that their blood pressure product was a regulated device in 2025, and it goes without saying Whoop was very likely in some ways responsible for this update. But frankly many other companies, both large and small, will benefit greatly from this new development in being able to operate a broader swath of products without FDA regulatory requirements, if they can properly align with these new guidelines.
This clearly was a missed opportunity for some in the mental health space. The Digital Health Advisory Committee (DHAC) meeting held on November 6, 2025 on GenAI mental health for digital health medical devices included advocates for more expansive general wellness allowances to specifically call out GenAI use for mental health. While this would have allowed potentially for non-regulated use of GenAI for mental health, this clearly was a bridge too far for even today’s FDA.
The General Wellness guidance was not listed as a candidate on the fiscal year 2026 priorities, which raises the question if any draft guidances on the 2026 “A-list” or “Under construction list” may similarly be released without public comment. One such proposed “return to draft” guidance on the “A-list” is the Policy for Device Software Functions, which currently is a final guidance titled Policy for Device Software Functions and Mobile Medical Applications.
And if this wasn’t news enough, the FDA simultaneously released a new final guidance update for Clinical Decision Support Software today (a review of this will be forthcoming).
