Is it necessary to show Model Number on the Labeling (meter box, label and manual)?

#1
Hi there,

Is it necessary to show model number on the labeling (meter box, meter label and manual)?

I cannot find the information anywhere on FDA website or FDA guidance...
Many thanks!
 
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Marc

Hunkered Down for the Duration
Staff member
Admin
#2
Re: Is it necessary to show Model Number on the Labeling (meter box, label and manual

A quick "Bump". My Thanks in advance to anyone who can help with this one.
 

yodon

Staff member
Super Moderator
#3
Re: Is it necessary to show Model Number on the Labeling (meter box, label and manual

Hate to see a good post go unanswered, so, despite my lack of expertise in this, I'll give it a shot (hopefully someone will follow on confirming or correcting).

I'm not aware of anything that requires the model number be included in the labeling. I re-reviewed:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=801
and
http://www.fda.gov/downloads/Medica...onandGuidance/GuidanceDocuments/UCM095308.pdf

Neither mentions model, specifically. They both indicate manufacturer (or applicable point of contact) and indications for use. There are special provisions for IVD, OTC, etc. so if your product falls under those, another check may be in order (although the closest I could find in those cases was the statement of identity for OTC).

I would think, though, that if your IFU covers a variety of models with different indicated uses, you may need to somehow identify the model & limitations on intended use.
 
M

MIREGMGR

#4
Re: Is it necessary to show Model Number on the Labeling (meter box, label and manual

Agreed.

I'm sure the general inspector-logic would be, if there is a possibility that the product could be mis-identified either in distribution or use, the labeling does not provide sufficient identifying information.

If a product is unambigously identified without a model number, that model number needn't be present on labeling. Note however that if a model number does exist...say, in a catalog or in marketing literature...the possibility of confusion as to what to call the product is obvious.

So my view would be: a product need not have a model number, but if it does have one, that model number should be consistently used in all labeling.
 
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