FDA Issues Proposed Rule Amending Regulations Regarding Acceptance of Data from Clinical Studies for Medical Devices


On February 25, 2013, the U.S. Food and Drug Administration (FDA) released a proposed rule entitled Human Subject Protection: Acceptance of Data From Clinical Studies for Medical Devices. 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. In addition, the proposed rule would require that clinical studies conducted inside the United States (“U.S. clinical studies”) and provided in IDEs and premarket notifications (510(k) submissions) comply with the applicable provisions of FDA’s existing regulations regarding the protection of human subjects, institutional review boards (IRBs), and IDE requirements as set forth in 21 C.F.R. Parts 50, 56, and 812, respectively. The proposed rule is intended to ensure the protection of human subjects and the integrity and quality of the data submitted. It is also intended to standardize the criteria for FDA’s acceptance of clinical data in support of IDE and premarket submissions. Comments on the proposed rule must be submitted by May 28, 2013.

I. Proposed Inclusion of Good Clinical Practice in the IDE Regulations -

The proposed rule would incorporate the GCP requirements for acceptance of foreign clinical studies in FDA’s investigational new drug application (IND) regulations into the IDE regulations by...

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