Home » Final Early Feasibility IDE Guidance Clarifies Informed Consent Needs
Final Early Feasibility IDE Guidance Clarifies Informed Consent Needs
November 5, 2013
The U.S. Food and Drug Administration issued a final version of its early feasibility study guidance on the eve of the federal government’s partial shutdown, adding detailed recommendations for informed consent documents in response to comments on the draft and the agency’s own experiences with a related pilot program.
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