The FDA held a virtual town hall today (February 11th, 2026) on the General Wellness guidance update which published on January 6th, 2026. This was a highly anticipated event to address questions on the guidance, which was reported previously in creating broader opportunities for products that the FDA does not intend to regulate. Submitters were allowed to supply in writing ahead of the town hall meeting and no questions were taken live during the virtual town hall. The FDA noted that meeting materials from the town hall (recorded presentation, slide deck, transcript) will be available in the future at CDRH Learn under “Specialty Technical Topics,” sub-section “Device-Specific Topics.”
The FDA presenters for the town hall included:
- Henry Roberts (Digital Health Specialist at FDA, Division of Digital Health Technology Assessment, Office of Strategic Partnerships and Technology Innovation)
- Aneesh Deoras (Assistant Director; Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices; Office of Cardiovascular Devices; Office of Product Evaluation and Quality)
After a slide deck presentation by both presenters noted above, which outlined some key points of the guidance, a Q&A session was conducted. Some key questions that were raised and addressed by FDA included the following:
- If a manufacturer has questions about the General Wellness guidance, what should they do? The FDA stated that if you have any questions about how the updated version of the General Wellness Guidance may impact your product, it was recommended that you submit a Pre-Submission (Q-sub) to the review division that may be responsible for your product or a product that provides similar physiologic parameters or values. Office of Product Evaluation and Quality, or OPEQ, review teams will be working closely with the Digital Health Center of Excellence, or DHCoE, to provide clear direction and consistency with the updated guidance.
- In situations where validation studies are generated where applicable to support a general wellness claim per the guidance, do the validation studies need to be made public? The FDA responded that a physiologic parameter or value can be validated through a variety of means, including testing conducted by the manufacturer and publication of validation results in a peer-reviewed journal. FDA encourages making validation results public. If information supporting the validation of a physiologic parameter or value are not made public, FDA may request a summary of the information supporting validation. Under this policy there are no specific requirements for validation, but manufacturers are encouraged to consider whether there exist relevant FDA guidance documents or performance standards, FDA-recognized voluntary consensus standards, requirements promulgated by professional societies, and other criteria.
- Does the general wellness guidance apply for both adults and children? The FDA responded by saying low risk general wellness products may be intended for use by both adults and children, provided the products are consistent with the policy that the product has a general wellness intended use and is low risk. Manufacturers should consider the characteristics of an intended use population in determining whether a product has a general wellness intended use. For example, measurement of blood oxygen in an infant population may not relate to maintaining or encouraging a general state of health or a healthy activity. FDA recommended reaching out to the review division responsible for your product or product that provides similar physiologic parameters or values for additional feedback on products intended for general wellness use by specific populations.
- Do cybersecurity requirements for regulated devices apply in cases of data sharing? The FDA responded by stating FDA does not intend to examine compliance with device requirements, including cybersecurity requirements, in the Federal Food, Drug, and Cosmetic Act, and its implementing regulations for low risk general wellness products. Data communication and privacy requirements administered by other agencies may apply. Patients may choose to share such data output from low risk general wellness products with their healthcare provider.
- What would an example “notification informing a user that evaluation by a healthcare professional may be helpful when outputs fall outside ranges appropriate for general wellness use” look like? The FDA stated product may still be a low risk general wellness product if it provides notifications when outputs fall outside ranges appropriate for general wellness use. These notifications should not name a specific medical disease or condition. However, ranges appropriate for general wellness use may fall within the clinical thresholds defined for specific medical diseases or conditions, such as 100 beats per minute for resting heart rate being an accepted clinical threshold for tachycardia. In this case, low risk general wellness products may provide notifications that align with clinical thresholds but should not include the numeric value of the threshold or name the specific medical disease or condition. Low risk general wellness products can also indicate that a physiologic parameter is higher or lower than a threshold; for example, “Your resting heart rate was high over the past few days. You should check with your doctor if this an unexpected result.” In addition, such notifications should not include other features, such as colors or sounds, that characterize the output as abnormal, pathological, or diagnostic. These limitations do not preclude notifications that are triggered by or include numeric values for thresholds defined by the user, user community, or those that are based on typical values for the user or user community, which may not be those typically used by the medical community.
- Are there low risk general wellness products that make reference to specific diseases or conditions? The FDA stated the General Wellness guidance includes a category of general wellness products that have intended uses that make reference to diseases or conditions and relate to sustaining or offering general improvement to functions associated with a general state of health. These products may help users live well with or may help reduce the risk of certain chronic diseases or conditions. As discussed in the guidance, these products do not perform non-invasive sensing of physiologic parameters.
Despite recent guidance on the expansion of situations where general wellness products would not be FDA regulated, it is clear from the town hall meeting that companies need to consider the Q-sub process to discuss their products to stay consistent with the FDA’s expectations for a general wellness product. Where applicable, the generation of peer-reviewed publications for support gives real advantages to companies that elect to go down this route, but these efforts take dedicated time and resources. Depending on the type of validation data being gathered, there could be requirements to go through an Institutional Review Board (IRB) process to gather what could be considered quasi-clinical data, even though the intent of the product is not for specifically named clinical or medical purposes. In the case of validation data that is not published in a peer-reviewed arena, it could be assumed for the moment that a summary of validation that the FDA may require would be supplied via a Q-sub. These are exciting times for general wellness product manufacturers, but as with most things the details matter, and clearly in some cases the FDA is signaling that it needs to be informed on those details, even for an enforcement discretion product the FDA does not intend to regulate.
