Regulatory News

Comment on FDA’s General Guidance: Policy for Low Risk Devices by April 20

Published on

The US Food and Drug Administration Center for Devices and Radiological Health has released draft guidance on General Wellness: Policy for Low Risk Devices. These general wellness products include consumer sleep trackers. You can comment on the draft guidance through April 20, 2015.

According to the draft guidance, the first category of general wellness intended uses involves claims about sustaining or offering general improvement to conditions and functions associated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. Among other claims, the wellness claims can relate to sleep management, such as to track sleep trends.

Per the draft guidance, the second category of general wellness intended uses is comprised of two subcategories:
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. An example is a product that tracks activity sleep patterns and promotes healthy sleep habits, which, as part of a healthy lifestyle, may help reduce the risk for developing type 2 diabetes.

This draft guidance, when finalized, will represent the FDA’s current thinking on this topic.