FDA Creates Unregulated Device Category for General Wellness Products

Saturday, February 21, 2015

Source: FDA News

The FDA has created a new category of devices – general wellness products – that the agency will exempt from regulation. The concept is a boon to makers of apps and other products that help manage weight loss, fitness, stress, sleep, and other aspects of good health.

For devices that the agency views as low-risk and satisfying other criteria laid out in draft guidance, the new category will lift the burden of seeking FDA clearance and manufacturing products under agency quality rules.

In addition, the FDA will even allow makers of the general wellness devices to offer certain disease-specific claims, as long as certain conditions are satisfied.

For devicemakers, the challenge will be sorting out those conditions so that their allowed wellness advertising and marketing claims don't inadvertently cross into treatment claims, that are not allowed.

In addition, devicemakers will need to be sure that their apps and devices satisfy the agency definitions of low-risk, otherwise the FDA can decide their devices require clearance and will be subjected to traditional regulation.

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