This message was posted by a user wishing to remain anonymous
Hi All,
I have a question about my company wanting to use packaging validations on the worst case packaging for a different product in our portfolio that was over 10 years ago in support of a product in a PMA. T validations are for shipping and to show the product remains sterile. However, the testing it is not the actual product and FDA may not consider it simulated.
I suggested they repeat the testing for our actual packaging since its PMA and not a 510k where they have used these other adoptions. and got clearance.
any thoughts on this. I was going to try and find a happy medium by suggesting a small sample size to redo testing 30 for 95% confidence)
IMO, we may need to redo it since its in support of an Original PMA and we need to create a baseline to support future PMA Supplements.
Thoughts or suggestions. I have never worked with this group before and they have never done a PMA so I am confused by the resistance to not have current state of the art testing.
thanks