Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

What is the risk if you sell products after 24Sep2018 that do not have UDI Direct Part Marking?


Also, if your device already has the lot code already on the device, do you still have to add it again if you are doing the human readable option?  I guess what I am asking is, do I need to put the (10) in front of the lot code?

If your product requires a DPM and it doesn't have one it would be considered adulterated.  There is a three year grace period for product already in distribution.  If there is a technical reason why a DPM cannot be placed on the device, that should be documented in the DHF.

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Patrick Kager
MedPharma Partners LLC
United States
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Original Message:
Sent: 13-Sep-2018 17:49
From: Anonymous Member
Subject: UDI direct part marking

This message was posted by a user wishing to remain anonymous

What is the risk if you sell products after 24Sep2018 that do not have UDI Direct Part Marking?


Also, if your device already has the lot code already on the device, do you still have to add it again if you are doing the human readable option?  I guess what I am asking is, do I need to put the (10) in front of the lot code?

​Hello Patrick,

Don't we need to get an exemption from the FDA if we are not doing the direct part making? Is it sufficient to have the same recorded in the DHF?

Regards,

Rashmi

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RashmiAdelaideAustralia
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Original Message:
Sent: 18-Sep-2018 16:58
From: Patrick Kager
Subject: UDI direct part marking

If your product requires a DPM and it doesn't have one it would be considered adulterated.  There is a three year grace period for product already in distribution.  If there is a technical reason why a DPM cannot be placed on the device, that should be documented in the DHF.

------------------------------
Patrick Kager
MedPharma Partners LLC
United States

Original Message:
Sent: 13-Sep-2018 17:49
From: Anonymous Member
Subject: UDI direct part marking

This message was posted by a user wishing to remain anonymous

What is the risk if you sell products after 24Sep2018 that do not have UDI Direct Part Marking?


Also, if your device already has the lot code already on the device, do you still have to add it again if you are doing the human readable option?  I guess what I am asking is, do I need to put the (10) in front of the lot code?