On February 11, 2026, the U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) held a Town Hall to address industry questions and provide further clarity on the January 6, 2026, update to the "General Wellness: Policy for Low Risk Devices" guidance document, which was initially issued in 2019. The updated guidance was intended to provide clarity and has largely been viewed as opening the door to providing consumers with additional information and metrics from analysis and sensors under the category of wellness and outside the scope of FDA regulatory review.

Reiterating Core Principles

FDA opened the presentation by affirming that the basic principles of the guidance document are unchanged, including the requirements for a general wellness product - i.e., intended only for general wellness use and presenting a low safety risk to users and other persons. Such products remain outside of FDA’s regulatory authority as they are not considered to be medical devices. FDA referenced that three new examples of general wellness products were added to the final guidance, which illustrate wrist‑worn or other noninvasive wearables that assess multiple activity‑ or recovery‑related biomarkers, estimate blood glucose for nutritional monitoring, and monitor athletic performance parameters such as electrolyte balance, lactate, and hemoglobin that would be considered wellness products and outside the scope of device regulatory oversight.

FDA further emphasized that a device may make general wellness claims, but it will not meet the criteria for a general wellness product if its technology is not low risk. To illustrate this point, FDA staff referenced laser products claiming to rejuvenate skin (and carrying associated skin and eye burn risks), neurostimulation devices marketed to improve memory (with electrical‑stimulation risks), and microneedle‑based continuous glucose monitors (categorized as invasive), noting that these represent examples where general wellness claims are undermined by higher‑risk technology, thereby bringing the products under FDA’s regulated device framework.

Reviewing Updates to the Guidance

FDA noted that a range of non‑invasive sensing technologies—including optical sensing and accelerometry used in the estimation of physiologic parameters such as blood pressure, oxygen saturation, blood glucose, and heart‑rate variability—may fall within the scope of general wellness when they are non‑invasive, intended only for wellness use, and satisfy the specific conditions set forth in the policy (specific qualifications discussed below).

While the prior 2019 guidance acknowledged that some non‑invasive sensors could support general‑wellness intended uses, the January 2026 update more clearly spells out the circumstances under which validated, non‑invasive physiologic estimates can remain non‑device, and expressly permits additional output formats—such as ranges, trends, baselines, and longitudinal summaries—when used to contextualize outputs in relation to sleep, activity, stress, recovery, or similar wellness domains. To qualify as a wellness product, such products must not pose safety risks requiring regulatory controls, must not diagnose, cure, mitigate, prevent, or treat disease, and must not be marketed as a substitute for an FDA‑authorized device. The updated guidance also gives more detailed guardrails around clinical framing or clinically suggestive presentation, clarifying that any claims or values that mimic clinical outputs remove the product from the general wellness category unless those values have been properly validated and confined to non-clinical use.

The agency also explained how a product may still be considered a general wellness product even if it includes a notification advising the user that consultation with a healthcare professional may be helpful when user-specific outputs fall outside ranges appropriate for wellness use—so long as the notification avoids clinical implications. Specific guardrails and a sample notification were shared by the agency during the Q&A portion of the town hall, as discussed below. These notifications must not identify or name a disease or medical condition, characterize outputs as abnormal or diagnostic, include clinical thresholds, diagnoses, or treatment recommendations, or provide ongoing alerts intended to manage a disease or condition. When these limitations are observed, user notifications remain compatible with a general‑wellness intended use.

The agency then addressed several emailed questions from industry that were collected ahead of the session; no questions were taken live.

What are FDA’s expectations for validation of measurement data?

FDA explained that manufacturers should validate the measurements their products produce and are encouraged to make this validation publicly available, including through peer reviewed literature when possible. While FDA does not prescribe specific validation methods as these products are not regulated by FDA, it encouraged manufacturers to consider FDA guidance documents, recognized standards, and professional society guidelines. The agency indicated that it may contact manufacturers to request validation information if such data is not publicly available, though the mechanism for doing so is uncertain considering that wellness products are outside of the scope of FDA regulatory authority.

What does FDA mean by “noninvasive”?

The agency articulated that wellness products are inherently low risk, and that low risk products are non-invasive, not implanted, and 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. FDA reiterated that noninvasive sensing may include modalities such as optical or motion‑based sensing and, in some cases, inflatable cuffs, while invasive technologies, including minimally invasive technologies like microneedles, fall outside the general wellness category.

With regarding to specific examples, the agency noted that certain noninvasive, software‑based glucose features may still qualify when used solely for general wellness. FDA further addressed urinalysis tools, stating that while a platform that incorporates urinalysis as a physiological input could theoretically fall within general wellness if low risk and intended solely for wellness, most urinalysis products currently cleared by FDA are authorized for clinical indications, such as detecting urinary tract infections, and therefore would not qualify.

What might be a permissible user notification based on analysis of data?

FDA explained that a general wellness product may notify a user that seeking evaluation from a healthcare professional could be helpful when outputs fall outside ranges appropriate for wellness use, but these notifications must avoid any clinical implication. A sample permissible notification (as described by the agency) could state: “Your resting heart rate was high over the past few days. You should check with your doctor if this is an unexpected result.”

The guidance provides the following parameters for permissible notifications:

  • must not imply a diagnosis by naming or referencing a disease or medical condition;
  • may align conceptually with clinical ranges but must not identify specific numerical thresholds available to users (e.g., 100 beats per minute for resting heart rate, an accepted clinical threshold for tachycardia);
  • may use general terms such as “higher” or “lower,” but not specific values; and
  • must not use colors (such as red or green), alarms, or sounds that imply a pathological or abnormal condition.

These restrictions do not bar notifications based on numeric thresholds defined by the user or a particular user community, including values typical for that group rather than those used clinically. There remains some uncertainty, however, regarding the appropriateness of setting the thresholds for notifications based on well-accepted clinical guidelines where the user is provided educational content in an app and then prompted to enter their own threshold values.

Do these clarified policies apply to products intended for both adults and children?

FDA confirmed that general wellness products can be intended for adults or pediatric populations, as long as the intended use aligns with the policy. However, manufacturers should consider population specific factors when determining whether an intended use is truly limited to general wellness. The agency provided the example that measurement of blood oxygen in infant populations may not relate to maintaining a healthy and active lifestyle and therefore may not qualify as a general wellness intended use.

Are there cybersecurity requirements or limits on data sharing?

FDA stated that while the agency does not intend to evaluate general wellness products for compliance with medical device cybersecurity requirements, other federal or state privacy and data‑protection frameworks may apply. The agency also confirmed that general wellness products may allow users to electively share data with healthcare providers.

Are any FDA-authorized medical devices affected by the updated policy?

FDA clarified that the updated policy does not exempt any previously authorized medical devices from active regulation. Products that sense physiologic parameters such as blood pressure remain regulated when their intended use if for clinical purposes and accordingly extends beyond general wellness. FDA also reminded manufacturers that labeling for general wellness products should not suggest that the product is medical or clinical grade, and cannot state or imply that can substitute for an FDA-authorized medical device.

FDA feedback and review

In closing, FDA encouraged manufacturers with individual questions to seek feedback from the agency via the Q submission program. Of course, seeking feedback through this formal device-based pathway would take several months, with a review time of 75 days, and would be subject to review by divisions associated with specific therapeutic areas and not necessarily the Digital Health Office and those involved in developing these general wellness policies.

The agency did not offer digital health mailbox as an option for seeking interactive feedback, though this may be a viable option for clear and discrete questions. However, the limited staffing in the Digital Health Office may mean that there are delays in response or the agency declines to review the inquiry.