REGULATORY WATCHCAT De Novo Post-Mortem 6 – How Does This Even Happen?


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To be clear, I don’t mean to criticize whoever it was that drafted the definitions for the Proposed Rule and/or responded to my comment. Well…except for apparently not having compared my comment to the section of Proposed Rule that I was commenting on, which should have at least clued them into the fact that I wasn’t suggesting keeping anything, but adding something. And seems to me like an obvious thing for them to have done.

What astonishes me is that someone who didn’t have strong writing skills and was generally unfamiliar with CDRH’s regulations was assigned to work on these tasks, apparently without any meangingful oversight of the end result. This was, after all, a Proposed Rule, one step below the Act itself. Really, one step below FDA being Congress. It was also the definitions, which are the foundation for understanding the entire Rule.

I can’t help but wonder if this reflects a conclusion on CDRH’s part, that the De novo pathway has been largely a bust, and therefore it was not worth investing the appropriate resources in the Proposed and Final Rule.

My full comment, CDRH’s response, and my full comments on its response, are attached.

The Regulatory Watchcat


  • De novo Post Mortem 6 Even Happen.pdf
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