FDA has historically taken the position that products intended to benefit a user’s overall health and wellness, and that did not make claims about disease prevention, treatment, mitigation, or cure, would not be regulated as medical devices. For example, in 1995, FDA issued Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Exercise Equipment. In that guidance, FDA stated:
Note that FDA regulates exercise equipment only if the equipment is intended to be used for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. FDA does not regulate exercise equipment intended only for general physical conditioning and/or for the development of athletic abilities in individuals who lack physical impairment. Therefore, it is not necessary to notify FDA of an intent to market a device if it will not be labeled or promoted for medical uses. However, FDA will regulate the equipment and may require premarket notification if any promotional material appears which makes medical claims after marketing begins.
When FDA issued the Mobile Medical Applications guidance in September 2013, it again repeated its position that it did not intend to regulate apps intended for general health and wellness.
Given this historical view on general wellness devices, FDA’s issuance of a draft guidance, General Wellness: Policy for Low Risk Devices, on January 16, 2015, would not, on its face, appear to present a major change to these types of products. There are, however, a few points in the guidance worth noting. First, FDA, for the first time, defines a “general wellness product” as a product that has:
- an intended use that relates to maintaining or encouraging a general state of health or a healthy activity, or
- an intended use claim that associates the role of healthy lifestyle with helping to 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.
Draft Guidance, at 3.
The second of these is particularly interesting, and appears to expand the category of general wellness products excluded from FDA’s jurisdiction. FDA states that this second category includes two subcategories:
- intended uses to promote, track, and/or encourage choice(s), which, as part of a healthy lifestyle, may help to reduce the risk of certain chronic disease or conditions; and
- intended uses to promote, track, and/or encourage choice(s) which, as part of a healthy lifestyle, may help living well with certain chronic diseases or conditions.
Draft Guidance, at 4 (emphasis in original).
The draft guidance includes examples of claims falling within this subcategory, including the product promotes physical activity, which, as part of a healthy lifestyle may help reduce the risk of high blood pressure. Another example would be a product that tracks caloric intake and helps manage a healthy eating plan to maintain a healthy weight and balanced diet, which in turn may help living well with high blood pressure and type 2 diabetes.
The significance of this is that the manufacturer may say more about the product than that it merely helps achieve a healthy lifestyle or may help aid in weight loss. It can then link those outcomes to potential benefits with specific disease states, implying that the product itself may, to a certain extent, help mitigate or reduce the risk of those disease states. FDA has included the caveat that it must be well known that healthy lifestyle choices are associated with improved outcomes for those diseases or conditions. This seems like a reasonable requirement, and still permits health outcomes claims that, prior to the guidance, may not have been permissible or were at least questionable.
This draft guidance is another welcome sign that FDA is attempting to focus its resources on high(er) risk products, and will not actively regulate products that present a low risk to the user. We hope to see this trend continue when FDA issues its draft guidance on regulation of clinical decision support software, on the “A-list” for development in FY2015.