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Are you wondering about FDA's UDI rule?  Here's a non-exhaustive summary:
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Are you wondering about FDA's UDI rule?  Here's a non-exhaustive summary:
Are you wondering about FDA's UDI rule?  Here's a non-exhaustive summary:
Are you wondering about FDA's UDI rule?  Here's a non-exhaustive summary:
Are you wondering about FDA's UDI rule?  Here's a non-exhaustive summary:
Are you wondering about FDA's UDI rule?  Here's a non-exhaustive summary:
Are you wondering about FDA's UDI rule?  Here's a non-exhaustive summary:
Are you wondering about FDA's UDI rule?  Here's a non-exhaustive summary:
Are you wondering about FDA's UDI rule?  Here's a non-exhaustive summary:
Are you wondering about FDA's UDI rule?  Here's a non-exhaustive summary:
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convenience kits (medical device), fda (food and drug administration), fda requirements, medical device standards and regulations, medical devices, single use devices (sud), unique identification (uid)
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  Post Number #9  
Old 9th October 2013, 01:00 PM
ScottDL's Avatar
ScottDL

 
 
Total Posts: 4
Re: Are you wondering about FDA's UDI rule? Here's a non-exhaustive summary:

You can refer to "Request for Modification of Unique Device Identifier Labeling Requirements for Devices That Have Small Labels" if you haven't already found it.
Find it at the federalregister(dot)gov under /articles/2013/09/24/2013-23059/unique-device-identification-system#h-30

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  Post Number #10  
Old 14th January 2014, 03:47 PM
medic61

 
 
Total Posts: 87
Please Help! Re: Are you wondering about FDA's UDI rule? Here's a non-exhaustive summary:

After spending the day reviewing articles and online information regarding the UDI process I have to say thanks to Kevin for the information on his blog and posts on the cove.
Can anyone answer a few questions please?
1. Seems like the UDI number is NOT the part number of the product, correct?
2. Is there anything stopping us from continuing to use our current 3d barcode which allows alphanumeric data? We have scanned products for traceability for over 10 years and have a lot invested in the process and equipment.
3. Regarding the UDI class I exempt items, are these the same devices listed as exempt for 510k?.
4. Would the UDI categories be linked to the FDA Product Code classifications?
Maybe it is too soon to ask for answers but...
Thanks
  Post Number #11  
Old 14th January 2014, 04:40 PM
Chrisx

 
 
Total Posts: 107
Re: Are you wondering about FDA's UDI rule? Here's a non-exhaustive summary:

Here is my understanding of it, having spent some time trying to learn more:

1. UDI is not the same as part number. UDI is a combination of device identifier and production identifier. Device identifier serves the same function as a part number, but production identifier could be lot#, serial number, expiration date or production date.
2. It depends upon which UDI issuing agency you use. GS1 only allows numeric UDIs. And barcodes have to comply to GS1 standards (e.g. GS1-DataMatrix). HIBCC allows alphanumeric. The barcode has to meet HIBCC standards, but this might be your existing barcode standard. The barcode will still be different, because it has to include both production and device identifier and meet the issuing agencies standards.
3. GMP exempt devices are exempted from UDI. This is not the same as exempt from 510(k). The FDA classification database identifies GMP exempt devices. They tend to be very low risk devices, like ice bags.
Thanks to Chrisx for your informative Post and/or Attachment!
  Post Number #12  
Old 15th January 2014, 02:38 PM
medic61

 
 
Total Posts: 87
Re: Are you wondering about FDA's UDI rule? Here's a non-exhaustive summary:

Thanks Chrisx:
Our barcode is Datamatrix and others have mentioned HIBBIC so that might be our route.
Regarding the device identifier, well that is another issue. We have over 30,000 part numbers just within one product family or GMDN code classification. I was hoping the identifier would be a group id, hmm.
I am sure I am not the only one that is curious so I will stay tuned.
  Post Number #13  
Old 24th January 2014, 04:42 PM
mr.mike

 
 
Total Posts: 94
Re: Are you wondering about FDA's UDI rule? Here's a non-exhaustive summary:

Correction to the original post, regarding date formatting:

I believe in the final rule, the acceptable date format is now YYYY-MM-DD.

e.g. today's date would be "2014-01-24" and NOT "JAN 24, 2014" as in the proposed rule and original post.
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