In the draft guidance General Wellness: Policy for Low Risk Devices, the FDA states that it will not regulate a general wellness product. However, such a product becomes a medical device subject to FDA regulation when it refers to its use for a specific disease or condition and that application is invasive or goes beyond the general goals of most wearables (e.g., help people monitor their exercise, food consumption and heart rate).
Specifically, devices that claim any of the following are NOT general wellness devices according to the draft guidance:
In the draft guidance Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types, the FDA states that it will regulate medical device accessories based on the risks they present when used with their parent devices, and not automatically based on the risks of their parent devices.
The public has 90 days to submit comments regarding the two draft guidances.