No.Does the device have to be fully transferred to production and ready for shipping?
I'd say verification needs to be complete but validation perhaps not 100% (you'll need to show something for usability for example).I'm wondering if all verification and validation testing needs to be completed before the submission
All safety testing has been completed but I'm wondering if all verification and validation testing needs to be completed before the submission or if it can continue in parallel while submission is being reviewed.
That's quite a sweeping statement. I think that "the FDA" is not that uniform or consistent.Any V&V testing that is part of the submission, i.e. data used to demonstrate safety and effectiveness must be completed. All risk controls must be completed and verified.
It used to be that FDA would allow some of the validation testing, like long term compatibility, or safety/electrical testing done by a third-party lab, to be finished while the submission was under the review, but that is no longer the case.
Additionally, you need to be finished with all performance testing that shows your device is substantially equivalent to the predicate if you are going thru the 510k pathway,Any V&V testing that is part of the submission, i.e. data used to demonstrate safety and effectiveness must be completed. All risk controls must be completed and verified.
It used to be that FDA would allow some of the validation testing, like long term compatibility, or safety/electrical testing done by a third-party lab, to be finished while the submission was under the review, but that is no longer the case.