FDA guidance on non-sterile Medical Device Packaging

#1
Hi everyone!

Currently working for a med device start up in the US.
I know that there are FDA guidance docs on Terminally Sterile Medical Device Packaging, however, we are having some trouble with our device which is non-sterile. We don't know how to conduct Packaging Validation and how to define our sample size.

All help will be appreciated!!! Thanks! :)
 
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#3
I think the ASTMD4169 is a good standard to fullfill packaging validation. Additonally "Canada recognized standards" - includes the ASTMD4169, too.
 
Last edited:
#4
I think the ASTMD4169 is a good standard to fullfill packaging validation. Additonally "Canada recognized standards" - includes the ASTMD4169, too.
Yes, I understand ASTM D1469, however, I am concerned that since the product is non-sterile, do we have to conduct a thorough packaging validation what so ever?
 

monoj mon

Involved In Discussions
#5
I am concerned that since the product is non-sterile, do we have to conduct a thorough packaging validation what so ever?
Yes, you will need to do it. The ASTM D4169 is for general purpose, it doesn't mention about any sterile barrier.
We have non-sterile product(s) with a shelf life. During premarket notification to FDA we were asked to provide all the validation testing (except for those related to sterility).
how to define our sample size
And for sample size, if you are contacting any third party organization to do the packaging validation, then it will be better if you discuss with them directly. Or there are many third party organization who provides such testing plan, you can also contact such organization and buy one plan for yourself.
 

levatorsuperioris

Involved In Discussions
#6
just because you didn't breach a sterile barrier does not mean your device still works (hint).

If your defibrillator no longer defibrillates after being jostled in shipping you have a problem.
If your devices loses lot traceability when it slips out of its packaging you have a problem.
Finally if your reusable surgical instrument can no longer be sterilized (SAL 10^-6) because the barrier was breached and you don't know what landed on it you have a problem.
 
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