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FDA Proposes Non-U.S. Clinical Trials Follow Good Clinical Practices

The Feb. 25 proposed rule amends regulations on acceptance of data from medical device clinical trials done outside the U.S. to support any submission to FDA to comply with good clinical practice standards.

FDA is requiring that medical device clinical studies conducted outside the United States to support any submission to FDA be conducted with good clinical practices, including review and approval of the study by an independent ethics committee and documenting human subjects’ informed review of the study.

The Feb. 25 proposed rule is “intended to update the standards for FDA acceptance of data from clinical studies conducted outside the U.S. and to help ensure the...

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