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Guidance on Device Data from Foreign Clinical Studies

04/21/2015

Federal Register Notice: FDA is making available a draft guidance entitled Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States; Draft Guidance for Industry and Food and Drug Administration Staff. It articulates FDA’s current policy of accepting scientifically valid clinical data obtained from foreign clinical studies in support of premarket submissions for devices. The guidance describes special considerations that apply when using such data, including applicability to populations within the U.S. and study design issues and provides recommendations to assist sponsors in ensuring their data are adequate under applicable FDA standards to support approval or clearance of the device in the U.S. This guidance is not intended to announce new policy, but to describe FDA’s existing approach to this topic. To download this draft guidance, click here. To view this notice, click here.

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