Apple Watch Is a Wellness Tool, Not a Medical Device: FDA

In December 2013, Apple executives met with representatives from the U.S. Food and Drug Administration (FDA) to see how the agency planned to regulate new, innovative products with sensors. Nine months later, the Apple Watch was announced, a wearable device which Apple says will help us “live a better day.”

The FDA has published a draft that clarifies whether a wearable device is also a medical device, thereby setting it up for governmental scrutiny. The draft, “General Wellness: Policy for Low Risk Devices,” could be approved after a 90-day public review process.

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