This draft guidance articulates FDA’s policy of accepting scientifically valid clinical data from foreign clinical studies in support of premarket submissions for devices. The guidance describes special considerations that apply when using such data, including applicability of the data to intended patient populations within the United States and study design issues, and also provides recommendations to assist sponsors in developing data that are adequate under applicable FDA standards to support approval or clearance of the device in the United States. This guidance is not intended to announce new policy, but to describe FDA’s existing approach to this topic. 



Posted on the FDA website on 22 April 2015