Does 510(k) submission need to include UDI Data

shimonv

Trusted Information Resource
#1
Hi Fellows,
Does anyone know if a 510(k) submission is expected to include UDI information?
Obviously UDI implementation is required before placing the production the field, but is it a must for the 510(k) application? The CFR's or the UDI FAQ is not clear about it.

Thanks,
Shimon
 
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Ronen E

Problem Solver
Moderator
#2
Re: Does 510(k) submission needs to included UDI data

The submission must include draft labeling that shows regulatory compliance. How can the labeling be compliant without the UDI?
 

shimonv

Trusted Information Resource
#3
It does make sense to include some form of UDI data, but the product is not yet cleared (and may not be) plus registration in the GUDID is irrelevant because the product is far from point of commercialization.

Somethings begin to be relevant once commercialization begins, like device registration. It's probably not s big issue but it can help small startups with scarce resources.

Shimon
 

Mark Meer

Trusted Information Resource
#5
Our last submission was during the transition period, and it was not even brought up (we developed the UDI after 510(k) approval).

Nowadays, it may be different, however. I agree with shimonv, that you should just do a UDI mock-up, or a place-holder area in your labelling that is clearly designated for a UDI.

MM.
 

invitro_spain

Involved In Discussions
#7
Hi Fellows,

I did the same question to two differents expertise. Both of them told me that it is not necessary during the 510(k) submission. In consequence, the labeling (including UDI requirements) shall be reviewed by the FDA during the Inspections.
In my case, my company has a Class II device.

This is the best information I have. Any feedback will be appreciated.
 
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