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by The Law Library (Author)
Human Subject Protection - Acceptance of Data From Clinical Investigations for Medical Devices (US Food and Drug Administration Regulation) (FDA) (2018 Edition) The Law Library presents the complete text of the Human Subject Protection - Acceptance of Data From Clinical Investigations for Medical Devices (US Food and Drug Administration Regulation) (FDA) (2018 Edition). Updated as of May 29, 2018 The Food and Drug Administration (FDA or we) is amending its regulations on acceptance of data from clinical investigations for medical devices. We are requiring that data submitted from clinical investigations conducted outside the United States intended to support an investigational device exemption (IDE) application, a premarket notification (510(k)) submission, a request for De Novo classification, a premarket approval (PMA) application, a product development protocol (PDP) application, or a humanitarian device exemption (HDE) application be from investigations conducted in accordance with good clinical practice (GCP), which includes obtaining and documenting the review and approval of the clinical investigation by an independent ethics committee (IEC) and obtaining and documenting freely given informed consent of subjects, which includes individuals whose specimens are used in investigations of medical devices. The final rule updates the criteria for FDA acceptance of data from clinical investigations conducted outside the United States to help ensure the quality and integrity of data obtained from these investigations and the protection of human subjects. As part of this final rule, we are also amending the IDE, 510(k), and HDE regulations to address the requirements for FDA acceptance of data from clinical investigations conducted inside the United States. The final rule provides consistency in FDA requirements for acceptance of data from clinical investigations, whatever the application or submission type. This book contains: - The complete text of the Human Subject Protection - Acceptance of Data From Clinical Investigations for Medical Devices (US Food and Drug Administration Regulation) (FDA) (2018 Edition) - A table of contents with the page number of each section
