FDA update addresses general wellness, medical use and non-invasive sensing for emerging technology

It’s an interesting start to 2026 for HealthTech wearable device companies. This week, the FDA announced they’re easing device regulation for general wellness products intended to promote a healthy lifestyle.[1] Non-invasive sensing was also addressed under general wellness. The FDA made a clear distinction between general wellness and clinical use; devices used for diagnosis or treatment are still expected to undergo strict regulatory reviews.

On January 6 2026, The US FDA Center for Devices and Radiological Health (CDRH) has announced it ‘does not intend to examine low risk general wellness products to determine whether they’re devices within the meaning of the FD&C Act or, if they’re devices, whether they comply with the premarket review and post-market regulatory requirements for devices under the FD&C Act implementing regulations’.

Defining the scope of general wellness vs medical products

Given that ‘health’ is a spectrum which can range from thriving to needing clinical care, the guidance offered clarification between general wellness and clinical use.

The CDRH defines general wellness products as products:

  1. Intended for only general wellness use (they go on to define what this means)

  2. Which present a low risk to the safety of users and other persons

  3. Intended to maintain or encourage a general state of health or a healthy activity

  4. With an intended use that relates the role of healthy lifestyle with helping 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

General wellness products are not those which were tied to clinical decision making. Anything intended to ‘measure, estimate, or report physiologic values for medical or clinical purposes, including screening, diagnosis, monitoring, alerting, or management of a disease or condition’ does not fall under the general wellness category.

Non-invasive sensing can also be used for general wellness

The FDA named products that use non-invasive sensing (for example, optical sensors) to measure physiologic outputs like blood pressure, oxygen saturation, blood glucose, heart rate to be general wellness products when the outputs are intended ‘solely for wellness uses’ 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.

The guidance provides interesting insight at a time where consumers have multiple opportunities to proactively address their health, while still being encouraged to rely on medical professionals and clinical experts for diagnosis and treatment.

  1. FDA General Wellness: Policy for Low Risk Devices. Available at: https://www.fda.gov/media/90652/download?. Accessed January 2026.