FDA Finalizes De Novo Process, Updates Related Guidance Docs
The pathway is used to clear class I and II products that don’t have a predicate device, including many innovative technologies. The original draft rule came out in 2018.
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The FDA will discuss the de novo request for opioid use disorder genetic test, AvertD.
Manufacturers can’t use the US FDA’s voluntary eSTAR product submission program for de novo requests until January – but they can start practicing now on how to use eSTAR for that review pathway.
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