Blood glucose meters would fall in the category requiring direct marking. Think about it from a user stand point. I get my first blood glucose meter, open the box, read the instructions (haha), start using my meter, throw the box away, throw the instructions away. Two years in the future something happens with the device, who do I call to get it fixed? The UDI number directly on the glucose meter can be looked up on the FDA GUDID database to determine who is the manufacturer. (Of course knowing the 70 year old user knows what UDI means and where to go on the FDA GUDID information to find the manufacturer ... another story.) The idea with the UDI and direct marking UDI is for traceability. As the glucose meter can be separated from its packaging and is reusable/multiple use/used more than once, then it needs the UDI on the device for direct marking purposes. Don't put too much into the phrase 'reprocessed before each use' the important part is the device is intended to be used more than once.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 02-Jul-2020 02:02
From: Spyros Drivelos
Subject: UDI requirement of directly mark a device
Hi Anon,
Will the blood glucose meter be used more than once or will be reprocessed (e.g. cleaned, assembled, etc) before use? If so, yes.
If it is single use then no.
Hope that helps
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Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece
Original Message:
Sent: 01-Jul-2020 01:41
From: Anonymous Member
Subject: UDI requirement of directly mark a device
This message was posted by a user wishing to remain anonymous
Hello,
Does class II blood glucose meter falls into the category of devices that should be directly marked with UDI?
What does reprocessed before each use mean?
"Under 21 CFR 801.45(a), if a UDI is required on a device label, that device is also required
to have a UDI permanently affixed to the device itself if the device is intended to be used
more than once and intended to be reprocessed before each use. "