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®: CRE Regulatory Action of the Week

FDA Proposes Changes in Foreign Clinical Studies Rules
The U.S. Food and Drug Administration is proposing to amend its regulations on acceptance of data from clinical studies for medical devices. The FDA is proposing to require that clinical studies conducted outside the United States as support for an investigational device exemption, application, a premarket notification submission, a premarket approval application, a product development protocol application, or a humanitarian device exemption application be conducted in accordance with good clinical practice, which includes obtaining and documenting the review and approval of the study by an independent ethics committee and obtaining and documenting freely given informed consent of study subjects. The proposed amendments are intended to provide consistency in FDA requirements for acceptance of clinical data, whatever the application or submission type. Submit either electronic or written comments on the proposed rule by May 28, 2013.

  • Click here to read EPA's Federal Register notice of proposed rules