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Hello, I am trying to get feedback on following questions:
1. Can you sell a convenience kit which contains medical devices and non-medical device? Eg. Toothbrush (device), Floss (device), For forensic use only product (non-medical device, not regulated by FDA)
I am trying to understand if we can combine a non-medical device with a medical device in a convenience kit.
2. Convenience kit with drug & device
a. If a customer orders a drug and a convenience kit (which has medical devices) on our website, and if we want to ship it together in one package without changing labeling, will this be classified as a "co-packaged combination product"?
b. If we purchase "off-the-shelf" OTC drug & device from a vendor, and put them together in one package (pouch/hard case) to create a kit, is it considered as "convenience kit" or "co-packaged combination product"?
Eg. Create a branded kit using off-the-shelf toothpaste (drug) and off-the-shelf device (toothbrush & floss). No changes to the labeling of the individual components.
Based on the preamble discussion of final rule for combo products, I am thinking that this wont be a co-packaged combination product since: all components are legally marketed independently, all components can be taken out of kit and legally marketed without modifying labeling, all components are labeled as per its own marketing authorization (if applicable) for independent sale, intended use remains same for all 3.
c. If it is classified as "convenience kit", do we need to create a kit label with UDI and other applicable labeling?