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We are introducing a class 2 medical device in the US for sale at the retail level. Our marketing department would like to "bundle" another product with this for sale to specialty markets. The second product would not be a medical product and would be shrink wrapped to the medical device. The medical device packaging would not be altered in any way and they would like to do this at our warehouse facility.
My question is, are there things the FDA would require the warehouse to do outside of what they would normally do for warehouse control because of this?
My question is, are there things the FDA would require the warehouse to do outside of what they would normally do for warehouse control because of this?