De Novo Classification
De Novo Classification is an FDA pathway for novel low-to-moderate-risk medical devices that have no existing equivalent to compare against. It lets a device obtain marketing authorization and establish a new classification and predicate, rather than forcing it into the high-risk premarket approval route.
What is De Novo Classification?
De Novo Classification is a U.S. Food and Drug Administration (FDA) pathway for novel medical devices of low to moderate risk that have no existing legally marketed equivalent to compare against. Because there is no comparable predicate device, such a product cannot use the more common clearance route that relies on demonstrating similarity to something already on the market.
The De Novo process lets the device obtain marketing authorization while establishing a brand-new classification. In doing so, it creates a predicate that future, similar devices may then reference.
Why does De Novo Classification matter for devices?
Without this pathway, a genuinely novel low-to-moderate-risk device would be pushed toward the most rigorous and demanding premarket approval route, which is designed for high-risk products. De Novo provides a more proportionate option that matches the regulatory burden to the device's actual risk level.
By setting up a new classification and predicate, De Novo also smooths the way for follow-on innovation in the same category. It balances getting useful new technology to patients with maintaining appropriate regulatory oversight.
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