Convenience pack FDA

Hi all,

Our company has a reusable medical device that is being used in hospitals and has a dedicated kit (procedure pack, single use content) that support the treatments.
The kit's content can serve only the intended purpose of our medical device system.
We are considering adding Vaseline to our medical devices kit (instead of using the hospital's Vaseline).
Vaseline is regulated in US under OTC drugs. Can we do that? Does it become combination product?

Thank you!
Yael

Yes, it would become a co-packaged combination product.
The combination product regulations are by necessity somewhat open ended and case-specific as there are so many different unique situations that could apply. The bottom line is that the same drug and device laws are applicable to the constituent components, so you need to provide all the information that would be necessary to support each component when used individually. In addition, you need to provide the supporting information for both components and their use together if the combination use brings up new questions of S&E. Your Primary Mode of Action is likely still the device, so you would submit the kit to FDA using whatever type of submission you would usually use. For the drug component, if it is an existing product, it may be permissible to "bridge" with the drug submission and just reference that information instead of submitting the information separately or redoing any V&V. This would all depend pretty heavily on the details for your product so there may be a few different routes that could apply.

Thank you very much!

Thank you again. I have additional question-
As a reminder, our company has a reusable medical device that has a dedicated kit (procedure pack, single use content) that support the treatments.
The kit's content can serve only the intended purpose of our medical device system.
We are considering adding sterile off the shelf product to the kit. Unfortunately, the off the shelf product is being provided in a box with many items inside. Meaning, we will need to repack it.

Assuming, the sterile device will not be affected by it.
And assuming if the secondary packaging has been designed by the off the shelf manufacturer to protect the integrity of the sterile barrier then further validation would be required on the new packaging.

In the above case, I understand we will become the legal manufacturer of the off the shelf product- is it correct?
What are the labeling requirements in such case? Can the imitate package contain the original label? What should we add on labeling?
BTW, I found a clear answer for the EU, under MDCG 2021-26, but I couldn't find such answer for the US.


Thanks!