Inside the FDA De Novo pathway for digital therapeutics
A practical overview of the classification process for novel, low-to-moderate risk devices.
Most people encounter FDA clearance language secondhand, through a press release. The actual pathway a novel digital therapeutic follows is less well known — partly because, for a genuinely new device category, the usual shortcut doesn't apply.
510(k) clearance requires an existing "predicate" device to compare against. A first-of-its-kind digital therapeutic often doesn't have one. That's what the De Novo pathway exists for.
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The De Novo classification pathway
1. Confirm no predicate exists
The sponsor determines the device doesn't fit an existing 510(k) category — there's no comparable, already-cleared device to reference.
It's a slower road than most software timelines are used to. But it's also what lets a De Novo device become the predicate for the next company's 510(k) — which is part of why the classification matters beyond the product it's attached to.