Quick Tip: Use consensus standards database to identify state of the art
Identifying relevant state of the art for your medical device can be tricky. A good source is FDA's consensus standards database.
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LTR 60: Defining state of the art can be challenging; here are a few tips.
“There is a very strong push (in the EU) to look at threshold values and acceptance criteria in the clinical evaluation, and these acceptance criteria for benefit risk have to be based on the state of the art.”