De Novo classification is a risk-based classification process.
The De Novo process provides a pathway to classify novel medical devices for which general controls alone, or general and special controls.
It has to provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device.
Devices that are classified into class I or class II through a De Novo classification request (De Novo request) may be marketed and used as predicates for future premarket notification [510(k)] submissions.
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