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FDA Finalizes De Novo Process, Updates Related Guidance Docs

 
• By Elizabeth Orr

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.

FDA entrance sign 2016

The US Food and Drug Administration issued a final rule for the de novo classification program on 4 October, increasing clarity for manufacturers whose products might reach market through that pathway.

Congress established the de novo pathway as an alternative for low- to moderate-risk products that had no predicate device in 1997, and greatly expanded it in 2011 by removing a...

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