FDA Finalizes General Wellness GuidanceAugust 4, 2016
On July 29, 2016, FDA finalized its guidance document, General Wellness: Policy for Low Risk Devices. The draft guidance, on which we posted here, was issued in January 2015. The final guidance is nearly identical to the draft, while providing a few more examples of products that would be considered general wellness products, and clarifying that to be considered “low risk,” the product must present not only a low risk to the user, but also to “other persons.”
In assessing the risk of a product, it would seem that a key determinant is the accuracy of the product. Yet in both the draft and final guidances, FDA notes that general wellness products may present risks, “such as inaccuracy,” but, “when made in the absence of disease or medical condition claims,” such inaccuracy “does not pose a risk to the safety of users and other persons if specific regulatory controls are not applied.” The lack of concern about product accuracy in the absence of a medical claim seems to provide a great deal of leeway to manufacturers seeking to enter the general wellness product marketplace. If a product’s inaccuracy were to lead to user harm, FDA may reconsider this position. However, in the absence of such harm—and with proper disclaimers as to the level of accuracy provided by the product—products that meet the definition of general wellness may be marketed without oversight by FDA.
Of course, it may not always be easy to determine whether a product meets the definition of a general wellness product. The guidance states that FDA “does not intend to examine low risk general wellness products to determine whether they are devices within the meaning of” the Federal Food, Drug, and Cosmetic Act. This means that manufacturers may self-determine whether the product they intend to market meets the definition of a general wellness product without seeking FDA’s opinion. Doing so, however, is not without some risk. For products that fit squarely within the examples provided by FDA, there should be no risk associated with going to market without complying with FDA regulatory obligations. It is reasonable to assume, however, that there are a number of potential products that meet the definition of a general wellness product as described in the guidance, but are not captured in the specific examples provided. For example, the guidance includes as an example of a general wellness product a “portable product that is intended to monitor the pulse rate of users during exercise and hiking.” Presumably, a portable product that is intended to monitor respiratory rate during exercise and hiking would also meet the definition of a general wellness product, but the extent to which companies may market products under the auspice of the guidance is not yet clear, given its recent issuance. It is safe to assume that FDA will disagree with the self-determination made by certain companies. The question is what the outcome of those disagreements may be.