The Next Big Thing For Medical Device Clinical Studies

Law360, New York (April 2, 2013, 11:26 AM EDT) -- On Feb. 25, 2013, the U.S. Food and Drug Administration released a proposed rule entitled Human Subject Protection: Acceptance of Data From Clinical Studies for Medical Devices.[1]

The proposed rule would require that clinical studies conducted outside the U.S. (“foreign clinical studies”) provided in investigational device exemption applications (IDE) or premarket submissions, including 510(k), Premarket Approvals (PMA), Humanitarian Device Exemptions (HDE), and Product Development Protocols (PDP) submissions, comply with Good Clinical Practices (GCP) or provide a justification for not complying with the GCP requirements.[2]

In addition,...
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