Convenience Kits-Not for Human Use

[Maryvicki]

Hello Forum,

We currently produce a non-sterile nursing kit for a college. The kit contains, gowns, swabs, mask, gauze, alcohol prep pads, several medical devices. The kit is sent to the student to practice with, these kits are labeled Not for Human Use.
Would they still be classified as a convenience kit and fall under regulatory requirements for 21 CFR 820 and the Interim Guidance for Convenience kits?

Thanks in advance for any insight on this.
Maryvicki

 

[Jen Kirley]

Hi Mary,

I don't feel adequately qualified to advise specifically, but I wanted to point out that the 21 CFR 820 Interim Guidance for Convenience Kits (is this the one you mean?) document is for sterilized and you said non-sterile. I did see a contact name and info in that document that would offer more binding advice than I can give you.

 

[Maryvicki]

Hi Jen,

Thank you for your input. I wil reach out to the contact in the guidance document.

 

[LUFAN]

More of a general comment and different angle, but if it's not for human or animal use, is it a medical device at all? And if it's not a medical device, then no UDI applies.

You could err on the side of caution and put the UDI if it was a convenience kit, but FDA might also consider that label misbranded.

 

[indubioush]

If an item states clearly that it is not for human use, then it is not a medical device. It is not (B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals.

I would add statements on the label indicating that the kit is for training use only and that it is not sterile.

 

[Maryvicki]

If an item states clearly that it is not for human use, then it is not a medical device. It is not (B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals.

I would add statements on the label indicating that the kit is for training use only and that it is not sterile.

Thank you!