Label - IFU requirement, maybe?

[katastic2908]

Good Morning,

I have a quick question that I am hoping someone can help me with.

I am evaluating one of our suppliers' IFU for a distributed product. I know on our IFUs we include page numbers, document number and current revision, and date of last revision. Is there a requirement somewhere for us to do this? If so can you please tell me the cfr number or section and standard it is in?

These aren't for implantables or life sustaining devices either.

TIA

 

[Mark Meer]

...
I am evaluating one of our suppliers' IFU for a distributed product. I know on our IFUs we include page numbers, document number and current revision, and date of last revision. Is there a requirement somewhere for us to do this? If so can you please tell me the cfr number or section and standard it is in?...

I am unaware of a CFR requirement (edit:see below), but it is good practice from a document-control perspective.

As far as other regulations, there is the European MDR, Annex I, 23.4:
"The instructions for use shall contain all of the following particulars:
...
date of issue of the instructions for use or, if they have been revised, date of issue and identifier of the latest revision of the instructions for use;
..."

EDIT: There is this requirement in 21 CFR §801.109:
"(e) All labeling, except labels and cartons, bearing information for use of the device also bears the date of the issuance or the date of the latest revision of such labeling."
Note this is for prescription exemptions...but again, still good practice.