New 2026 FDA Wellness Guidance Provides Broader Exemptions

 The FDA’s Jan. 6 guidance for general wellness products does not represent a wholesale overhaul of the previous version, but developers of these products may find that more of their products will now be exempt from regulation as medical devices. 

The FDA released two guidances for digital products in the first week of January, including a rewrite of the guidance for clinical decision support (CDS) software products. FDA Commissioner Marty Makary discussed both guidances in a social media post also dated Jan. 6, in which he states that the new guidances are part of an emphasis on artificial intelligence at the agency. Makary said the wearables addressed in the wellness guidance are known for their ability to detect early physiological changes that are associated with disease. “We have a clear lane for medical-grade products,” Makary stated, although he endorsed the notion of reducing needless barriers for products that do not fall under the agency’s regulatory regime.

While the wellness guidance does not apply to combination products, the FDA cited the 21^st Century Cures Act as having exempted several software functions from FDA oversight. Among these are software intended for maintaining or encouraging a healthy lifestyle so long as the software’s output is unrelated to diagnosis or treatment of a disease.

A wellness product can aid the user with both weight and sleep management while a software product that claims to treat or diagnose obesity would be a regulated product and thus would not escape regulatory oversight. A software product that is intended to promote choices that help to reduce the risk of certain chronic diseases may also be exempt from regulation, as would products that promote a healthy lifestyle with the intention of aiding the user’s efforts to live well with chronic diseases or conditions. However, these claims must be backed by information such as peer-reviewed medical literature.

The guidance states that a wellness product cannot by marketed as a substitute for a device that is cleared or approved by the FDA as a regulated device. A wellness product also cannot include claims that the outputs can be used to prompt or guide specific clinical action or a course of medical management of the patient. While a wearable article that is a non-regulated wellness product can display vital signs, they cannot be marketed with claims that the output can be used for screening purposes.

The guidance lists several functions that would make the product a regulated medical software function, such as outputs that refer to specific diseases, clinical conditions, or diagnostic thresholds. The agency stated that a product may be deemed a wellness product if it includes a notification that the user may want to consider an evaluation by a medical professional. In doing so, however, the output cannot refer to a specific disease or condition.

The risk of a product plays a significant role in determining the status of that product under the wellness policy. An example of this is a product that claims to improve athletic performance by providing suggestions on the basis of a reading of lactic acid provided by venipuncture blood samples. The venipuncture is invasive and hence would disqualify the product from the unregulated status of a wellness product. However, a product that provides estimates of blood glucose levels will avoid the FDA’s regulatory regime if it provides glucose data by means of a minimally invasive component such as a microneedle unit because a microneedling component penetrates only to the level of the stratum corneum, the outermost layer of the epidermis.

Both the wellness guidance and the CDS guidance are immediately effective, although the FDA did not provide a draft version of either guidance. This does not comport with the agency’s own good guidance practices as a general matter, but Makary stressed the need for the FDA “to get out of the way as a regulator” in his Jan. 6 social media post.