New Draft Guidance Outlines FDA’s Key Considerations in Accepting Foreign Data

On April 21, 2015, the Food and Drug Administration (FDA) released a draft guidance document, Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States, discussing considerations related to the acceptance of foreign clinical data in support of investigational device exemptions (IDEs) and marketing applications for medical devices.

Read more: New Draft Guidance Outlines FDA’s Key Considerations in Accepting Foreign Data


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