When FDA Decision Summary opens?

Brian K

Starting to get Involved
#1
Hello,

I found many brand new devices cleared by FDA via De-novo pathway, but many of them are not providing FDA Decision Summary.

When this information opens? Does it depend on manufacturer's decision?

Thanks
 
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Watchcat

Trusted Information Resource
#3
First, none of this will be set in stone until CDRH issues the Final Rule. Second, there's been a pandemic going on lately.

I also do not think this is at the requester's discretion, but what CDRH is required to post...that's one of those things that is not set in stone. I would guess they are clearly required to post the Reclassification Order, but not so clearly required to post a Decision Summary. So, with the pandemic, they seem to have not been posting Decision Summaries since early 2020, probably because they have not been doing anything they didn't feel they were required to do....by law first, and also trying to keep their MDUFA commitments.

If there is a particular summary or summaries that you are interested in, just email whoever signed the letter on CDRH's behalf. I have done this a number of times in the past, and they always sent the summary, although sometimes I had to ask again. However, I only asked about those that were clearly lingering behind most of the other Decision Summaries that had been posted, on the assumption that it was available, and just hadn't gotten posted. As I recall, before user fees were being charged, that could be up to 6 months. They seemed to be posting them more promptly since they began to charge user fees, and then...along came the pandemic.

I also was doing this pre-pandemic. Today, many summaries might still not be available to post or to share.
 

Brian K

Starting to get Involved
#4
If there is a particular summary or summaries that you are interested in, just email whoever signed the letter on CDRH's behalf.
Highly appreciate for your reply

I haven't known there is pathway for requesting decision summary to CDRH.
Can I send a request freely or is there any form to fill out?
 

Watchcat

Trusted Information Resource
#5
There isn't supposed to be, but if one hasn't been posted for 6 months and pretty much all them are being posted with 3 months, then I for one won't hesitate to ask if the one that hasn't been posted is available. I think sometimes it simply falls off the radar and no one realized it hadn't been posted yet. Usually if I ask and they are in a helpful mood, they email me the summary and also post it.

Email addresses for divisional management can be found here:
CDRH Management Directory by Organization

Email addresses for other FDA employees can be found here:
HHS Employee Directory

Go at it with the mindset that you are asking for a favor, and, these days, that there is a pandemic on. Most FDAers are oriented to be helpful, but not all of them, and like most people, when they get overloaded, less so.
 
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