Hello all...
I have a query regarding predicate device shelf life testing.
In one of the performance testings at accelerated conditions, we have to compare the subject device with the predicate.
If the predicate device's shelf life is 2 years and 1 year of shelf life is already over, how will I calculate its accelerated aging time? Will it be based on its remaining shelf life or shall I keep it for same period of acceleration as that of subject device? Kindly inform..
The test results will be submitted to US FDA.
Thank you.
I have a query regarding predicate device shelf life testing.
In one of the performance testings at accelerated conditions, we have to compare the subject device with the predicate.
If the predicate device's shelf life is 2 years and 1 year of shelf life is already over, how will I calculate its accelerated aging time? Will it be based on its remaining shelf life or shall I keep it for same period of acceleration as that of subject device? Kindly inform..
The test results will be submitted to US FDA.
Thank you.