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FDA Requirements for Medical Device Label Reconciliation

S

Schkund

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#1
#1
Does the FDA have any sort of requirements for label reconciliation for finished medical devices? I know that the pharmaceutical industry has some regulations on accounting for all labels printed in order to avoid counterfeits, but I'm not sure if the medical device industry has similar requirements. The verbiage that I see in 21 CFR 820.120 seems to be intended to avoid mixups between lots of labeled product, not what I'd consider label reconciliation. 21 CFR 801 doesn't seem to tackle control of printed labels either, only the expected material contained on the label itself.

We currently have a label reconciliation process for each of the labels we print for finished medical devices, but it is cumbersome and challenging to maintain with our current resources. If we can, we'd like to take label reconciliation out of some of our processes (or at least simplify the current label reconciliation process), but I want to be confident that we will not introduce a regulatory gap in doing so.
 
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shimonv

shimonv

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#2
#2
The volume and risk profile for pharmaceuticals is such that requires label reconciliation.
The CFRs for devices don't have such a requirement and I have not seen seen it implement in a similar way to pharmaceuticals (21 CFR 211.125(c)).
I believe you can simply the process.

Shimon
 
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hello1234

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#3
#3
It's generally a good idea to reconcile labels after a batch or to print on demand (eliminating the need to reconcile). There is no requirement from the FDA to reconcile labels, but it is recommended. There was a guidance document awhile ago that mentioned the FDA recommended reconciliation as a way to prevent mix-ups.

"The Quality System regulation does not require reconciliation of the number of labels used versus the number issued, although this control is recommended for some devices, such as when different sizes of the same product are being packaged or otherwise labeled."
 
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