wearable health fitness device

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The FDA recently published a draft of regulations for wearable health gadgets. Manufacturers should follow these guidelines in order for the FDA to classify their products as “general wellness” devices. Under this classification the devices can monitor basic vitals, like heart rate, potential calories burned, and metrics like distance walked. However, they cannot diagnose or suggest medical treatments to the user. Otherwise, they would fall under vital medical equipment and treatments, and would be subject to different rules and regulations all together.

According to the FDA, “both subcategories of disease-related general wellness claims should only contain references where it is well understood that healthy lifestyle choices may reduce the risk or impact of a chronic disease or medical condition. That is, the claim that the healthy lifestyle choice(s) may play an important role in health outcomes should be generally accepted; such associations are typically described in peer-reviewed scientific publications. Examples of chronic diseases for which a healthy lifestyle is associated with risk reduction or help in living well with that disease include heart disease, high blood pressure, and type 2 diabetes.”

This means that a “general wellness” device should promote things like healthy weight and sleep management, fitness, relaxation, mental acuity, self-esteem and sexual function. These devices are meant to enhance a person’s life not claim to cure things like obesity or insomnia.

Since this is still a draft, there is no obligation to seek approval or adhere to any set of FDA guidelines. Right now, getting a “general wellness” classification is just an option for manufacturers for products they deem as “low risk devices.” But companies with similar products to be released down-the-line should start considering exactly what their devices can and cannot do to avoid unforeseen technical issues. For example, you can claim that your device helps manage diabetes, but one faulty firmware update and some tardy insulin shots later, can lead to a whole lot of lawsuits. It might be best to stick to tracking your hearts beats-per-minute and body temperature, because no company wants to be responsible for the harm or death of a consumer.

The FDA has essentially made a distinction between consumer grade off-the-shelf wearables gadgets and medical devices. By defining what tech companies can and can’t claim about a product, this ensures that you can’t buy something from Best Buy and try to cure or self-diagnose yourself.