Bev, thanks for clarifying that. I see there may be cases where n=1 is acceptable; however, I believe it would be very difficult to justify an N of one for a high risk, sterile Class III device.
This is the feedback my company received years ago from US FDA regarding a Class III sterile device:
"In xxx Packaging Test Report – ....
We noted in several places of this report an unusually low sample size (n=10). Please be reminded that a risk analysis should be performed to determine the number of samples to be used during your studies. ....we recommend 95%/90% confidence and reliability."
This is the feedback my company received years ago from US FDA regarding a Class III sterile device:
"In xxx Packaging Test Report – ....
We noted in several places of this report an unusually low sample size (n=10). Please be reminded that a risk analysis should be performed to determine the number of samples to be used during your studies. ....we recommend 95%/90% confidence and reliability."