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Hi there,
Now it's my turn to turn to the cove for guidance.
We manufacture medical devices and sell them to our sister company in the US. They use the products for kits, pack, sterilize and sell them. We, however, hold the FDA registration of the products.
Whose responsibility, under FDA regulation, is the contents of the Directions for Use enclosed with the kits??
Please help
Now it's my turn to turn to the cove for guidance.
We manufacture medical devices and sell them to our sister company in the US. They use the products for kits, pack, sterilize and sell them. We, however, hold the FDA registration of the products.
Whose responsibility, under FDA regulation, is the contents of the Directions for Use enclosed with the kits??
Please help

Gert, if it was my decision and I was the person or entity listed as the manufacturer with FDA, I would provide the labeling. I think, otherwise it might prove to be troublesome in the future.