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Advantages to pursuing a Special 510(k) instead of a Traditional 510(k)

Watchcat

Trusted Information Resource
#1
Has anyone found any advantages to pursuing a Special 510(k) instead of a Traditional 510(k)? Other than that it sounds so special? :)
 
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chris1price

Trusted Information Resource
#2
I have made one Special 510(k), where we had to change the source of an ingredient for an IVD, but there were no changes to the intended use manufacturing processes or the performance data. We only had to show equivalence between the new and old systems, and not go through the whole 510(k) process.

If you meet the necessary criteria, its worth trying :)
 

Watchcat

Trusted Information Resource
#3
Thanks, Chris. Your response seems to support my best guess, which is that it is worth doing for one or a few changes, limited in scope, but something more like a full version upgrade to an old model of device, maybe not so much. The wider the scope of changes, the more the Special and Traditional may converge.
 
Last edited:

monoj mon

Quite Involved in Discussions
#4
I once submitted one special 510(k) where we,

1. Added one accessory (510k exempt device) to the system.
2. Made some design change to the previously cleared device for better performance (in terms of ergonomics and durability) and submitted it as the Gen-2 device while keeping vital technical specification identical.

It took me exactly one month (which includes the e-mail conversations with the reviewers for additional information) to get the 510(k) clearance. So, it was worthy in my case to go via special 510(k) pathway.
 
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