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What is meant by “Least Burdensome approach” by the FDA

The FDA believes that you should take the least Burdensome approach in all areas of medical device regulation. They have carefully reviewed relevant scientific and legal requirements and have come up with methods they believe to be the least burdensome approach.

 If however you believe you have a method that is less burdensome than the FDA’s recommendation then you should contact them so that they can consider your method.