When is it appropriate to use study data from outside the U.S. to support FDA applications? FDA's Center for Devices and Radiological Health ("CDRH") and Center Biologics Evaluation and Research ("CBER") recently published a new draft guidance entitled "Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States. With this Draft Guidance, FDA aims to minimize the possibility for additional or duplicative U.S. studies, to harmonize global clinical trial standards, and to promote public health and innovation. Mason Weeda, Esq. from the law firm Olsson Frank Weeda Terman Matz PC, will review FDA's regulation and provide some insight on what FDA may focus on when evaluating the adequacy of an outside of the USA study.

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