Final Early Feasibility IDE Guidance Gives More Tips on Informed Consent

The FDA issued a final version of its early feasibility study guidance on the eve of the federal government’s 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. Under the guidance, companies are encouraged to start human trials earlier and to conduct more early studies in the U.S.
Devices & Diagnostics Letter