FLYER | FDA De Novo Authorization procedure

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. 

Discover all about De Novo on this flyer, from classification request to post-market and maintenance.  

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