ITA (Investigational Testing Authorizations) - Labeling requirements

[Jen C]

Hi all - just hoping to confirm my understanding of the rules for labeling of investigational devices in Canada.

The MDR (Section 86) requires the investigational statements to be present in English and French, but doesn't make any statement about where on the packaging these words must appear (as far as I can see). I also don't see any requirements about location of the statements in the ITA guidance. I don't even see it in the draft ITA guidance for consultation, even though the draft does introduce some interesting new "requirements" for labeling (bilingual!!!).

All that said, I have it in my head that I have seen a requirement for the statements to be on the device or the immediate package. I may just be getting mixed up with the US requirements in 21 CFR 812.5, which DO require the statement to be on the immediate package.

Our device (Class III, prescription only) is sterile inside a jar, and then the jar is placed inside a box (this is what sits on the shelf). So my understanding is that we are OK for Canada if we have the statement only on the outer box, but that in the US we would need it to be on the jar.

I'd appreciate it if anyone can confirm my thinking here!

Thanks,
Jen

 

[RA Guy]

Hi Jen:

I don't believe you will find official Canadian requirements for where to place the investigational labels.

My approach with both investigational and non-investigational devices has always been to feature the required labeling statements as close to the product as possible (i.e, ideally direct marking for example on a piece of hardware).

As you will need to submit risk management evidence for a Class 3 ITA, I would propose addressing the labeling approach there. What is the risk of labeling the box vs. the jar? What are the limitations to physical labeling of the device given its physical nature (size, shapre, sterility, etc.)? At least this approach may preempt some review questions and/or give the reviewers confidence that you thought about this in your design process.