Tag Archive: ClassII

Sep 07 2012

De novo device reclassification: What have you done for me lately?

The recently passed FDA Safety and Innovation Act makes major changes to the de novo reclassification process for medical devices.  Namely, the new law mandates that a manufacturer can simply submit a request to the FDA for de novo classification without having a previously rejected 510(k) application. Medical devices are classified in a three-tiered classification …

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