Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

I know that for traditional 510(K), there is a section of draft labeling. Does Unique Device Identifier needs to be a part of traditional 510(K) for class II Medical Device.
Reason Why I am asking this question because after 510(K) clearance, our organization is not going to manufacture the device. Basically after clearance , organization will sold the technology to third party. 

Any thought!

Hi, 

At this time, there is no requirement that a 510k requires the UDI draft labeling. Although, I do add placeholders e.g. samples of what it could look like <g class="gr_ gr_170 gr-alert gr_gramm gr_inline_cards gr_run_anim Grammar only-del replaceWithoutSep" id="170" data-gr-id="170">but I</g> do not generate the number. 

Good luck!

------------------------------
Rory Carrillo
RAC Medical, LLC
San Francisco CA
------------------------------

Original Message:
Sent: 25-Sep-2017 23:03
From: Anonymous Member
Subject: Unique Device Identifier

This message was posted by a user wishing to remain anonymous

I know that for traditional 510(K), there is a section of draft labeling. Does Unique Device Identifier needs to be a part of traditional 510(K) for class II Medical Device.
Reason Why I am asking this question because after 510(K) clearance, our organization is not going to manufacture the device. Basically after clearance , organization will sold the technology to third party.

Any thought!

Original Message------

This message was posted by a user wishing to remain anonymous

I know that for traditional 510(K), there is a section of draft labeling. Does Unique Device Identifier needs to be a part of traditional 510(K) for class II Medical Device.
Reason Why I am asking this question because after 510(K) clearance, our organization is not going to manufacture the device. Basically after clearance , organization will sold the technology to third party. 

Any thought!

This message was posted by a user wishing to remain anonymous

Thanks Rory and Ginger!
Original Message:
Sent: 27-Sep-2017 07:23
From: Ginger Cantor
Subject: Unique Device Identifier

Hello Anonymous,

You don't have to have a UDI on until you market, but FDA likes you to realize it is required. 

Here is what you can do. Add a place on your draft labeling primary package to represent the UDI. Even  text box that says ""UDI goes here " with a sample bar code below.  

Also if your device itself requires direct marking, show a picture or drawing with a place for it.

If you don't do this in the 510(k), then you will most likely be asked to revise the label to show it during review.

After 510(k) clearance, you can follow FDA's Q & A guidance for transfer of 510(k)

Good luck,

Ginger Cantor, MBA, RAC

Centaur Consulting LLC centaurconsultingllc@gmail.com

715-307-1850

Original Message------

This message was posted by a user wishing to remain anonymous

I know that for traditional 510(K), there is a section of draft labeling. Does Unique Device Identifier needs to be a part of traditional 510(K) for class II Medical Device.
Reason Why I am asking this question because after 510(K) clearance, our organization is not going to manufacture the device. Basically after clearance , organization will sold the technology to third party.

Any thought!