Wearable electronics designed to offer health-related benefits to users seem to be drawing increased attention from the US Food and Drug Administration (FDA). Though the expanding market of these “wearables” has not been brought under the category of “medical devices,” the administration recently issued a Draft Guidance for Industry that represents the FDA’s thinking about the wearbles. That draft guidance appears to be an initial framework for classifying these products according to function and claims regarding effectiveness.
The 11-page document states that it aims to provide clarity to industry and FDA staff members about the Center for Devices and Radiological Health’s (CDRH) compliance policy for low-risk products that promote a health lifestyle, also sometimes described as general wellness products. Components of the draft are not legally enforceable, and are intended only to offer recommendations unless otherwise noted in the document.
Wearables, referred to in the document as “general wellness products,” are identified in the draft as those described by two definitions. The first defines them as “products intended for only general wellness use, as defined in this guidance. The second definition describes them as products that “present a very low risk to users’ safety.” Among the products that would fit these definitions are exercise equipment, audio recordings, video games, software programs, and related items.
Furthermore, the draft guidance clarifies what constitutes a general wellness product. It defines them as those that have an intended use that relates to “Maintaining or encouraging a general state of health or a health activity. That definition also includes products that make 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.”
According to the draft guidance, the first category of general wellness intended uses do not make reference to disease or conditions. The document outlines them as follows:
· weight management,
· physical fitness, including products intended for recreational use,
· relaxation or stress management,
· mental acuity,
· self-esteem (eg, devices with a cosmetic function that make claims related only to self-esteem),
· sleep management, or
· sexual function.
The complete draft guidance is available at the FDA website.
[Source: US Food and Drug Administration]