Skip to main content

FDA Creates Unregulated Device Category for General Wellness Products

This article was reposted from the FDA news website.

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For devices that the agency views as low-risk and satisfying other criteria laid out in draft guidance, the new category will lift the burden of seeking FDA clearance and manufacturing products under agency quality rules.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

For more information, devicemakers should register today for FDAnews’ upcoming webinar: General Wellness Products: How to Make the FDA’s New Policy Work for You.