The US Food and Drug Administration (FDA) automatically classifies Class I or II medical devices without a predicate as class III.
De novo process allows these low risk devices to be re-classified via a request for a risk-based (re)classification from the FDA.
If rejected, the device will remain class III (and consequently request a PMA application). A similar level of product information as a 510 (k) clearance process is expected by the FDA.
De Novo procedure is currently not widely used procedure however utilized increasingly.
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