DE NOVO FINAL RULE IS PUBLISHED

Watchcat

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#1
Well, here it is.

The Regulatory Watchcat will no doubt have something to say about the subject in the future. First observations, without having looked at the rule itself, are that 1) "classification" doesn't sound promising and 2) seems clear that they sat on it until the first weekday of FY 2022.

What the latter might mean, I don't know, but I'm pretty sure it means something. Maybe very little, maybe not.

FDA Issues Final Rule and Updated Guidance for De Novo Classification Process
 
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