Hi at all.
I have question regarding a 510(k) submission.
1. is it possible to start the 510(k) submission without doing the full shelf life test? If we assume that the shelf life of the device is 3 years, but we only do an accelerated aging of 1 year, with the idea of starting the submission as soon as possible. At the same time, we are working on Acc. Aging for 3 years. Or does it not make sense as it will only bring more problems and queries from the FDA.
Thank you!
I have question regarding a 510(k) submission.
1. is it possible to start the 510(k) submission without doing the full shelf life test? If we assume that the shelf life of the device is 3 years, but we only do an accelerated aging of 1 year, with the idea of starting the submission as soon as possible. At the same time, we are working on Acc. Aging for 3 years. Or does it not make sense as it will only bring more problems and queries from the FDA.
Thank you!