On January 19th, the FDA released draft guidance about wearables dated January 20th, proving not only do they have access to a time machine, but they are totally willing to rub our noses in it. The document, which you can download here, relates to the FDA’s policy on what it deems as “low risk devices,” i.e., wearables.
Low risk devices, by the FDA’s definition, are those that, “involve claims about sustaining or offering general improvement to conditions and functions associated with a general state of health that do not make any reference to diseases or conditions.” And, more specifically, a general wellness device has,
1) 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 diseases or conditions; and,
2) 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.