510k - Product shelf life validation

Jen

Starting to get Involved
#1
I am currently helping my company to prepare documents for 510k. I have some questions for the frequency of testing for product during accelerated aging test. Is it acceptable for FDA we only conduct the tests for the product before and after accelerated aging test?
 
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chris1price

Trusted Information Resource
#3
I don't believe FDA has any requirements for interim test points when performing accelerated (or eal time) aging. Take a look at ASTM F1980, it is the best guidance available. (unfortunately, I no longer have a copy to refer to.) ISO11607 also provides more general information.

The advantage of interim time points, are that they provide information if there is a failure and may enable you to launch with a reduced shelf-life.

Chris
 
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