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Hello all,
I have a question about accelerated aging test.
I am working on 510k for the first device of our company. The device is similar to surgical clips, which is composed of ABS,PC, pure titanium and stainless steal, etc. FDA asked for additional information about the accelerated aging test. Specifically, FDA required to provide scientific evidence that the material used in our device decomposed with similar mechanisms at elevated and standard temperature.
Right now, we cannot provide real-time aging test now to valid the accelerated aging.
Could you provide me some suggestions to solve this problem?
Thank you.
Nicole
I have a question about accelerated aging test.
I am working on 510k for the first device of our company. The device is similar to surgical clips, which is composed of ABS,PC, pure titanium and stainless steal, etc. FDA asked for additional information about the accelerated aging test. Specifically, FDA required to provide scientific evidence that the material used in our device decomposed with similar mechanisms at elevated and standard temperature.
Right now, we cannot provide real-time aging test now to valid the accelerated aging.
Could you provide me some suggestions to solve this problem?
Thank you.

Nicole