Health-focused wearables facing greater government scrutiny

The FDA gets involved

Apple Watch

Many of the companies who are getting in on the wearables craze have made lofty claims about health and fitness, and now those companies will face greater scrutiny from the government.

The problems arise as smartwatches gain more sophisticated medical sensors, like heart rate monitors.

Actual medical devices are regulated by the US Food and Drug Administration, but the line between these smartwatches and legitimate medical equipment is being blurred more with every new smartwatch announcement.

Watch what you say

The FDA hasn't taken any action yet, but it has published a draft guidance regarding "policy for low risk devices," requesting input from the public.

The Administration isn't worried about gadgets like the Fitbit and Apple Watch, which monitor your sleep and tell you to get off your butt once in a while, but anything that makes specific claims - like that it will help you lose weight, or prevent heart attacks, or whatever - may fall under its purview.

Wearables is a rapidly evolving area of tech right now, and the FDA is doing well to start looking at it now, before things spiral out of control.

Via Engadget

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