I waited my entire career for the direct De novo. After FDASIA was passed, I enjoyed over five long and shining years of delight and anticipation.
Right from the start, everyone I spoke to at CDRH and in industry called it a "mini-PMA" (that would be 'A' as in Approval). They got it, they really got it! The draft and final guidances were solid. It seemed like the direct De novo was going to be just what I always thought the industry needed, and had arrived on the scene not a moment too soon, after decades of "me too" had made a mockery of innovation and driven the industry all too quickly through its lifecycle, perhaps even into an early grave.
Then CDRH published its Proposed Rule for De novos. And now...
Now I have no idea what the De novo will turn out to be. Whatever becomes of it, my De novo---the one I waited for all those years---will always be my one true Regulatory love. And I'm not prepared to abandon it, just because someone tried to throw acid in its face.
Below I have posted draft and final guidances, the Proposed Rule, and my comments on the Proposed Rule.
It is my intention to eventually summarize all the data and information on direct De novos available in the CDRH De novo database. This is no small task, and I don't plan to work on it 24/7/365. So far I've compiled some summary statistics, including timeframes from receipt to decision, for De novos with decision dates 2015-2018. I've looked at the impact of MDUFA fees on submissions and estimated the number of De novo requests that did not result in a positive outcome. I've also summarized the information on biocompatibility that was included in the decision summaries.
So, it is over. In the end, something of a mercy killing, I guess.
The Final Rule was published October 5, something of a testament to CDRH's and industry's failure of imagination. The De novo as nothing more than "starter dough" for more 510(k)s. And, given the number of submission over the past six years, still something of a dud. Or maybe not in spite of it, but because of it. Really, who needs yet more yet another's, anyway?
In any case, this brings me close to closure on the subject.
I have read through some of the preamble to see how CDRH responded to some comments, especially my own, and comment on those of particular interest to me.
I will probably also post a list of what I considered key points that CDRH didn’t cave on, at least not too much.
I will continue to maintain my statistical summary of whatevered De novos. However, given the lack of enthusiasm with which industry and CDRH have not exactly embraced this not-so-brave-after-all new pathway and the impact of the pandemic, I think it will be at least another three years before anything like enough De novos have been posted for any trends to emerge. Maybe more like five.
Otherwise, the Regulatory Watchcat is now ready to de-prioritize the De novo and move on to other projects that have been languishing.