Is my product "general wellness" or a medical device?

In short: FDA's general wellness policy keeps low-risk products that promote healthy lifestyles without referencing disease out of active FDA oversight — as enforcement discretion, not a blanket statutory exemption. The test is claims plus risk — not technology. A wellness label does not override clinical marketing language: one disease claim in your copy, store listing, or investor deck framing can make you a device.

What genuinely qualifies as general wellness

FDA revised its General Wellness Policy on 6 January 2026, replacing the 2019 version with a more detailed test. A product qualifies if it's intended solely for wellness use and is non-invasive; doesn't involve technology posing a meaningful safety risk; isn't intended to diagnose, cure, mitigate, prevent, or treat a disease; isn't intended to substitute for an FDA-cleared or FDA-approved device; doesn't carry claims, functionality, or outputs that guide clinical management; and doesn't output values that mimic clinically-used values unless validated. The update is notably more permissive on one specific point that surprises founders: non-invasive wearables that output physiological parameters — including blood pressure — can now qualify as general wellness products if the intended use stays strictly wellness-focused, which wasn't as clearly stated under the 2019 guidance. A product can use identical underlying sensor technology to another that's clearly a medical device and still qualify under the wellness policy, purely because of how it's positioned and what it outputs. One precision worth holding onto: this is largely an enforcement-discretion policy — FDA "does not intend to examine" qualifying low-risk products — rather than a guaranteed statutory exemption from device status.

Where products actually drift out of wellness territory

The drift is almost always gradual and almost always happens in marketing copy rather than in engineering. "Track your sleep patterns" is wellness. "Detect signs of sleep apnoea" is not — even if the detection logic existed in the product from day one and the marketing simply caught up to what the feature could technically do. The same pattern shows up with heart-rate monitoring drifting into "detect atrial fibrillation," or mood tracking drifting into "screen for depression." Each step feels like a natural, honest description of a real capability; each one also moves the product across FDA's line. The 2026 guidance also draws a firm line at invasiveness that no amount of wellness-framed marketing gets around: FDA specifically calls out a blood-glucose wearable using minimally invasive microneedle technology as not low-risk, regardless of how purely wellness-oriented its claims are. And even for a permitted parameter like blood pressure, alerts or notifications that prompt specific clinical action can pull the product back into device territory.

The practical audit

Write down every distinct health-related claim your product currently makes — across the app itself, your website, your app store listing, and any recent investor or press materials — and check each one against two questions: does it reference a specific disease or condition, and could a reasonable reader conclude the product is meant to diagnose, treat, or monitor that condition. Any claim that fails either test needs either rewriting or a genuine regulatory strategy behind it, because "we didn't mean it that way" is not a defense FDA recognizes once a claim is public.

Where next: Wellness App or Medical Device? The FDA Line · Do I need FDA clearance for my health app?

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