Do I need a "State of the art" plan?

[katezhang]

Hi， I am writing the state of the art
however， currently， there's only a general requirement on it
and someone suggest to provided a process to show the state of the art is also a continous process
my question is do i need state of art plan?and then have a report, do I need seperate literature search protocol specific for the state of the art?
it brings too much paper work......

 

[indubioush]

It does not make sense to have a plan just for state of the art. State of the art needs to be considered for your clinical evaluation and when designing new products. You need to ensure you have a provision in your clinical evaluation plan and design and development documentation for assessing state of the art.