UDI- RFID Labeling

[QAengineer13]

Dear all,

In my current project we are thinking of using the RFID for UDI, could you please share with the me your experience on implementing the labeling requirements for UDI using RFID.

Thanks in advance!

 

[miken99]

Healthcare companies have decided to focus on barcode at this point. RFID will probably follow in years to come.
I suggest you check with your customers before going too far. You could be out on a limb......alone. They may not have the required infrastructure, readers, antennas, software, etc. Plus, RFID is tricky and not nearly as precise and mature as barcode.

 

[Al Rosen]

FDA requires a label. See
Federal Register:: Unique Device Identification System

 

[miken99]

Al,
search for 'direct marking' in the federal register posting of the FDA rule and you will see what and why

 

[Al Rosen]

Al,
search for 'direct marking' in the federal register posting of the FDA rule and you will see what and why

Got it
801.45c2
Automatic identification and data capture (AIDC) technology, or any alternative technology, that will provide the UDI of the device on demand.

Thanks.