Lexology January 14, 2026
Since 2019, companies that offer software and/or hardware devices aimed at promoting consumer health and wellness have had little more to rely on than a single short U.S. Food and Drug Administration (FDA) guidance document to determine whether their product qualifies as a “general wellness product” that falls outside the scope of active regulation by FDA as a medical device. The ability for a device to go straight to market without the numerous regulatory obligations that apply to traditional “medical devices” can have a significant impact on market strategy, costs and timing of product launch.
That changed last week when FDA issued an updated final guidance titled “General Wellness: Policy for Low Risk Devices” on January 6, 2026. While FDA’s...
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