The final rule will require that data submitted by sponsors and applicants from clinical investigations conducted outside the United States 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). GCP includes the review and approval by an independent ethics committee (IEC) before initiating an investigation, continuing IEC review of ongoing investigations, and obtaining and documenting the freely given informed consent of subjects. The rule is intended to update our standards of acceptance of data from clinical investigations and to help ensure the quality and integrity of data obtained from these investigations and the protection of human subjects.

Regulatory Impact Analysis

Human Subject Protection; Acceptance of Data from Clinical Investigations for Medical Devices (Final Rule) RIA

Federal Register: 83 FR 7366 (February 21, 2018)

Docket: FDA- 2013-N-0080