Do I need FDA clearance for my health app?

In short: Only if your app is a medical device: making disease-related claims or performing diagnosis, treatment, monitoring, or care recommendations. Wellness apps that avoid disease claims typically don't need clearance. If you do, the pathway — usually 510(k) or De Novo — depends on whether a predicate exists.

The first question: are you a device at all

Before asking which FDA pathway applies, confirm you actually need one. Apps that track general fitness, sleep habits, or wellbeing without referencing a specific disease or making a diagnostic or treatment claim generally fall outside FDA's device definition and need no clearance at all. The line moves the moment your app's claims — anywhere, including marketing copy, not just the interface — reference disease diagnosis, treatment, or monitoring in a clinically specific way.

If you are a device, which pathway

Once you've confirmed device status, note that some low-risk device types are 510(k)-exempt — a device, but with no premarket submission required. For the rest, the practical pathway question is usually 510(k) versus De Novo. A 510(k) requires demonstrating substantial equivalence to a predicate device already legally on the market with the same intended use and comparable technology. If no such predicate exists — because your product is genuinely novel but still low-to-moderate risk — De Novo classification is the route, creating a new device type and, often, a new predicate for others to reference later. High-risk devices with no low-risk pathway available go through PMA, though this is rare for consumer health apps specifically.

The word that matters: clearance, not approval

FDA "clears" 510(k) submissions, "grants" (authorizes) De Novo requests, and "approves" PMA submissions — these aren't interchangeable terms, and using "approved" for a 510(k)-cleared product is both technically incorrect and, if it appears in your marketing, a potential compliance problem in its own right. Most health apps that end up needing FDA authorization will be seeking 510(k) clearance or a De Novo grant, not approval — a distinction worth getting right from your first piece of marketing copy, not correcting later.

Where next: Does My Health AI Need FDA Clearance? · Is my product "general wellness" or a medical device?

Find out in minutes where your product likely sits. Start the MedTech Compass → — AI-generated first read, not a validated determination.