820.120 UDI (Unique Device Identification) Labeling Verification Requirements

I

Imecoli

#11
OK, we have implemented the new labels, but I have one follow up question if anyone can help.
We manufacture class II tests, pregnancy and DOA urine tests. based on the standard...

Sec. 801.40 Form of a unique device identifier.
(a) Every unique device identifier (UDI) must meet the technical requirements of 830.20 of this chapter. The UDI must be presented in two forms:
(1) Easily readable plain-text, and
(2) Automatic identification and data capture (AIDC) technology.

we are now required to have the scan-able bar code and also the data coded in said bar code printed as well? is it me or does this sort of defeat the purpose for the streamlining? I see how scanning the bar code assures no transcription errors, but why would you have the readable text next to it if you already label lot number, exp date etc on the label?

:deadhorse: or is it just me?

Thanks
 
Elsmar Forum Sponsor
Q

QA-Man

#12
OK, we have implemented the new labels, but I have one follow up question if anyone can help.
We manufacture class II tests, pregnancy and DOA urine tests. based on the standard...

Sec. 801.40 Form of a unique device identifier.
(a) Every unique device identifier (UDI) must meet the technical requirements of 830.20 of this chapter. The UDI must be presented in two forms:
(1) Easily readable plain-text, and
(2) Automatic identification and data capture (AIDC) technology.

we are now required to have the scan-able bar code and also the data coded in said bar code printed as well? is it me or does this sort of defeat the purpose for the streamlining? I see how scanning the bar code assures no transcription errors, but why would you have the readable text next to it if you already label lot number, exp date etc on the label?

:deadhorse: or is it just me?

Thanks
It is an interesting question. The duality may have to do with the long term plans for UDI that are being worked out behind the scenes. I read they were going to replace HCPCS and be entered into EHR's.

After all, why barcodes at all?
 
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