R
rakma
MIREGMGR,
I understand and agree with all your clarification and I don't want to pursue this too much, but to conclude: bottom line is if you are selling the device in bulk non-sterile form, then you do not have the legal responsibility of regulatory compliance for the final product (kit). It would not affect you if the repackager markets it as class I or class II. It would not be labeled under your name anyways.
We had seen a similar issue and our take on this was as I mentioned above, though the repackager were not selling the device as class I, we were not sure about their sterilization revalidation of the kit. The sterilization validation of the kit would need to be redone though the method was still ETO. We did send a letter to them indicating that they should follow their own regulatory procedures for assessing the regulatory implication of repackaging. I do understand your point on wanting to avoid any agreement issues.
Anyways, it was a good discussion. Thank you. Good luck for resolving the issue.
Rakma
I understand and agree with all your clarification and I don't want to pursue this too much, but to conclude: bottom line is if you are selling the device in bulk non-sterile form, then you do not have the legal responsibility of regulatory compliance for the final product (kit). It would not affect you if the repackager markets it as class I or class II. It would not be labeled under your name anyways.
We had seen a similar issue and our take on this was as I mentioned above, though the repackager were not selling the device as class I, we were not sure about their sterilization revalidation of the kit. The sterilization validation of the kit would need to be redone though the method was still ETO. We did send a letter to them indicating that they should follow their own regulatory procedures for assessing the regulatory implication of repackaging. I do understand your point on wanting to avoid any agreement issues.
Anyways, it was a good discussion. Thank you. Good luck for resolving the issue.
Rakma
