On February 21, 2018, FDA amended its regulations on the acceptance of data from clinical investigations for medical devices. Under the new rule, FDA is requiring that data submitted from clinical investigations conducted outside of the United States (OUS) 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
humanitarian device exemption (HDE) application, or a product development protocol (PDP) application, be from investigations conducted in accordance with good clinical practice (GCP), which includes review and approval by an independent ethics committee (IEC) and informed consent from subjects.
The GCP requirements in the final rule encompass both data quality and integrity and ethical standards for device clinical investigations.
