AMA on UDI

  • 27 May 2022
  • 8 replies
  • 111 views

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We invited Gary Saner from Reed Tech for an exclusive AMA (ask me anything) session to talk UDI.

Please let us know if you have any issues accessing the recording. We hope this was a beneficial session and we’re looking forward to seeing you next week!
 


All the best,
Etienne Nichols


8 replies

Hello. My name is Sophia and I work as QA& RA manager and PRRC for a dental industry in GR with exports in more than 60countries. I have put my questions in a pictorial way in 2 slides. I would be more than grateful in Gary could answer to my questions since I have searched MDR, MDCGs, FDA 21 CFR and cannot find the answer to the specific cases.

Thank you in advance

Sophia

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Is there any reason why a company would NOT use GS1? It seems like they are the most universal issuing agency, and I’ve not heard about a major backlog (but I’m out of the loop on this.) 

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We’re just getting into the Direct Marking part of UDI. What are some of the difficulties you’ve seen companies getting into with this? It seems straightforward enough… We’re planning to mark HRI & 2D barcode, provided there is room on the part. Is there any issue with stacking the HRI, or does it have to be a continuous string of characters? 

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Along Owen’s question, doesn’t the Direct Marking have to last the life of the part? Is this just done through simulated testing/accelerated aging, or is this something that would be included in a proactive post-market surveillance plan?

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Are there guidelines about the Production Identifier? Specifically, how is the manufacturing date defined? Typically some time has elapsed between the time that we’ve printed our labels and the final inspection occurs. What are best practices regarding applying these dates?

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What are some perspectives on IMDRF's harmonized global UDI system? The variances  between different jurisdictions UDI requirements may seem minor, but I know they also can wreak havoc on UDID. Is there any chance we'll ever see a unified single system, or is the global economy just to disparate and location-specific?

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Serialized Class II product with laser etched UDI. For a compliant DHR per 820.184, what level of record is required for direct marking? Is list of system generated UDI sufficient, or is additional objective evidence required, such as pictures or screen captures? 

 

 

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