FDA amended its regulations on the acceptance of data from clinical investigations for medical devices. The rule updates the FDA’s standards for accepting clinical data from clinical investigations conducted both inside and outside the United States to help ensure the protection of human participants, and to help ensure the quality and integrity of data obtained from these clinical investigations.
The final rule is intended to help ensure the quality and integrity of clinical data and the protection of human subjects.
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.
The rule requires that sponsors and applicants of submissions and applications that include clinical investigations conducted OUS and submitted to support of an IDE or device marketing application or submission provide information regarding how the investigations conform to GCP.
The final rule allows for a level of flexibility such that when GCP is not met, statements can be included in premarket submissions and applications, for FDA’s consideration, explaining why the investigation was not conducted in accordance with GCP and describing the steps taken to ensure that the data and results are credible and accurate and that the rights, safety, and well-being of subjects have been adequately protected.
