New Draft Guidance Document for FDA's current thinking on De Novo submission


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Hi all,

FDA has issued draft guidance on 14 Aug to provide updated process for de novo submission

It looks almost similar to draft guidance of 2011. De Novo Process chart is updated and simplified, Pre de novo submission (PDS) is merged with pre-submission

De novo may be submitted via two pathways:
1. Pre-Submission (Pre-Sub) - though not necessary, it provides FDA's preliminary perspective on device and documents required for de novo
2. De novo - with or without 510 (k) (direct de novo)

Some other points from guidance document:

FDA must make a classification within 120 days (if approved)
If device is classified as class I or II, it may serve as a predicate device
New class of device will be published in the Federal Register (classification and the necessary controls)
If the de novo is declined, the device will remain in class III


  • de novo classification process (2014).pdf
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