Agency makes changes based on industry suggestions . . .

FDA Finalizes Rule On Human Subjects Protection In Device Trials

By David Roza / February 22, 2018 at 8:28 PM
Presented with compelling evidence, FDA will allow device sponsors to sidestep a requirement that companies demonstrate their clinical investigations -- conducted both inside and outside the United States -- followed good clinical practices (GCPs), including human subjects protections, the agency announced in a final rule released Tuesday (Feb. 20). While FDA says sponsors could always have explained why they didn't follow GCPs, FDA created a formal waiver process in response to concerns from industry that there is not a global...


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