REGULATORY WATCHCAT - De Novo Proposed Rule - General Comments

Watchcat

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With the Final Rule now on FDA's Unified Agenda, I was going to do a high-level summary of the comments it received on the Proposed Rule. Then I realized I could comment extensively on many of the extensive comments.

I decided I’d do a high-level summary first, and then comment on the comments later. I soon decided that a high-level summary wouldn’t offer enough value for the time it would take me to compile one. (“I don’t have time to be brief.”)

So now I'm tackling them a bit at a time, with my comments. Many comments were received about the proposed content of a De novo request. Most of them were about specific information CDRH proposed for inclusion in a De novo request, but some were more general in nature. The more general comments and my comments on those comments are attached. I plan to cover the more specific comments later, one item at a time. Should CDRH issue a Final Rule before I'm done , I'll stop and comment on the Final Rule instead.
 

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