FDA Wants to Regulate Some Wearables, But Fitbit's Fine

With so many health-focused wearables hitting the market, the U.S. Food and Drug Administration is clarifying which of them can skate by without tighter regulations.
Under the proposed guidance, the FDA’s Center for Devices and Radiological Health won’t examine what it considers “low risk general wellness” devices. If all the device does is promote better health through awareness and coaching—as fitness trackers from Fitbit and Jawbone do—they’ll be free from scrutiny under fed