Teri Sturgell
Registered
I have a question about co-packaged medical device/drug convenience kits.
The medical device is a class II with market approval and the drug is an OTC monographed product already on the market and registered with the FDA. We want to put the two products into a kit for convenience but they will not be used together and/or at the same time. They would retain the original labelling and DFU's, would this type of kit need to still seek additional approval through the FDA Office of Combination Products or could the kit be registered under CDHR as a convenience kit?
Thank you in advance for any clarification that can be provided.
Teri
The medical device is a class II with market approval and the drug is an OTC monographed product already on the market and registered with the FDA. We want to put the two products into a kit for convenience but they will not be used together and/or at the same time. They would retain the original labelling and DFU's, would this type of kit need to still seek additional approval through the FDA Office of Combination Products or could the kit be registered under CDHR as a convenience kit?
Thank you in advance for any clarification that can be provided.
Teri
