RAPS: FDA Guidance Explains How Medical Device Companies Can Rely on Foreign Clinical Data

New draft guidance issued by the US Food and Drug Administration (FDA) seeks to make it easier for medical device companies to rely on data obtained from clinical studies outside the US, provided those studies are conducted to appropriate federal standards. The draft guidance document, Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States, is closely related to a rule proposed by FDA in February 2013. That rule, Human Subject Protection; Acceptance of Data from Clinical Studies for Medical Devices, proposed requiring all clinical studies conducted outside the US in support of a device application comply with US regulations on good clinical practice.

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