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Demystifying the De Novo Process

Global Medical Device Podcast powered by Greenlight Guru

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The Five Ten K Pathway

There's a couple of ways people can arrive at the decision. People may try to do a pre submission meeting and get the opinions of fda. Sometimes they might go the five ten cape pathway, and fda just says, nop, it's not so tinks e gonlk yo have to go to nova. That happens pretty rarely. When we do our searches for substantial predicate devices, you could use something that was a genova a one point time. If there 's nothing that new in itfadeof, you know, that's when we would look at the danoba.

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