Co-packaged convenience kits FDA

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
 

v9991

Trusted Information Resource
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
I do not have any regulatory experience., though, it ought to be registered, even if its convenience kits;
Unique Device Identification: Convenience Kits

also, refer. the details @ FDA Webinar: Unique Device Identification: Convenience Kits Final Guidance
 
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