The De Novo Classification process allows manufacturers to obtain a Class I or II classification for new devices that do not have a legally marketed predicate device or that have received a “Not Substantially Equivalent” (NSE) determination in a 510(k), but present a low or moderate risk.
In the absence of a suitable predicate, these devices could automatically be classified as high risk (Class III), requiring PMA (Premarket Approval). However, the De Novo process offers a more appropriate pathway for products that do not meet the Class III risk level.
Discover all about De Novo on this flyer, from classification request to post-market and maintenance: FDA DE NOVO AUTHORIZATION PROCEDURE
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