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FDA De Novo Database Search

Find granted De Novo classification requests for novel low- to moderate-risk devices, including the new classification name, product code, device class, requester, and decision date.

Novel device decisionsNew predicate directionDecision-document linksFDA De Novo data through the openFDA 510(k) endpoint

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Find a De Novo by device name, requester, DEN number, or FDA product code.

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How De Novo decisions affect pathway research

A granted De Novo creates a new device classification and product code for a novel low- to moderate-risk device that lacked a suitable predicate.

After classification, later devices may be able to use the De Novo device as a predicate in a 510(k), but substantial equivalence still depends on intended use and technological characteristics.

Read the classification order, special controls, decision summary, and regulation rather than relying only on the device name or product code.

Read the official FDA dataset documentation

What is the FDA De Novo pathway?
De Novo is a classification pathway for novel devices of low to moderate risk when there is no legally marketed predicate suitable for a 510(k).
What does a granted De Novo create?
FDA classifies the device into Class I or II, creates a new classification regulation and product code, and identifies applicable controls.
Can a De Novo device become a 510(k) predicate?
Yes, a legally marketed device classified through De Novo can potentially serve as a predicate for a later device when substantial equivalence can be demonstrated.

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