The FDA has proposed changes to its requirements for medical device clinical trials conducted outside the U.S., including mandating that manufacturers provide documentation on human subjects' informed consent as well as on trial evaluation and approval by an independent ethics panel. The proposal is up for comment through May 28.
FDA plan would revise rules on device trials outside U.S.
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|Director, Site Quality Management||
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|Associate - Food and Drug||
Keller and Heckman LLP
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