FDAnews Device Daily Bulletin

Good Clinical Practice in Overseas Trials Mandated Under FDA Proposed Rule

March 5, 2013
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Sponsors seeking a green light to market a medical device in the U.S. would have to demonstrate that any overseas clinical trials of the product conformed to good clinical practice, according to an FDA proposed rule. The rule seeks to bring the U.S. in line with global GCP standards for devices.
Devices & Diagnostics Letter