All posts on July, 2015


IDG Contributor Network: Oh, joy. NeuroMetrix’s forthcoming app may require FDA approval

When it became apparent that medical and fitness uses would be one of the biggest drivers for wearables, a lot of people groaned. The Food and Drug Administration would have to get involved.

As it turned out, the FDA was doing some groaning of its own about the prospect, and earlier this year, it released draft guidance for low-risk medical devices that essentially said it was taking a hands-off approach. These are general wellness devices, it said of the new class of wearables that measured sleep and exercise and calorie consumption. It wouldn’t be coming after consumers’ beloved Fitbits.

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