The FDA will regulate wearable gadgets that make health claims, the regulator has released new guidance related to wearable gadgets and health.
The FDA is attempting to clarify the regulations relating to wearable gadgets and devices and they will determine which devices are medical devices.
According to the guidance, a wearable gadget that could be used to treat a specific illness would be classified as a medical device.
Other devices which are not designed to treat specific illnesses but may be used for monitoring your health and fitness like smart watches will be classified as wellness devices and will not need regulation like medial devices.
This could change in the future as more software is added to these devices, and a number of companies have plans to work with health providers on their devices, which could lead to reclassification in the future.