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U.S. Department of Health and Human Services

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Summary: Regulatory Impact Analysis of Human Subject Protection; Acceptance of Data from Clinical Studies for Medical Devices

The proposed rule will require that clinical studies conducted outside the United States and used to support investigational device exemption (IDE) applications, premarket notification (510(k)) submissions, premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, or product development protocol (PDP) applications comply with good clinical practice (GCP). In addition, the proposed rule seeks to amend the 510(k), HDE and IDE requirements for FDA acceptance of data from clinical studies conducted inside the United States to parallel existing FDA requirements for PMA applications.

Regulatory Impact Analysis